[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"M.D. Anderson Cancer Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":510},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,566,0,25,[9,40,62,85,105,127,152,171,191,212,232,249,268,287,304,324,343,361,381,400,417,435,455,472,490],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100544466","phase-1-prorad-5-prostate-radiation-in-5-fractions-phase-ii-five-fraction-radiotherapy-for-patients-with-advanced-prostate-cancer-100544466",false,"NCT06369246","PRORAD-5 PROstate RADiation in 5 Fractions: Phase II Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer.","Inclusion Criteria:\n\n1. Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate within one year of study entry. Evaluation can happen outside of MD Anderson as long as histological confirmation takes place at MD Anderson.\n\n   1. cT1c-T3a by digital exam or imaging (AJCC 8th Ed.). No cT3b-4 by digital exam or imaging (AJCC 8th Ed.)\n   2. Gleason Grade Group 2-5 (Gleason 7, 8, 9, 10).\n   3. If Gleason Grade 2, must meet definition of unfavorable intermediate risk (at least one of the following: cT2b, and\u002For ≥ 50% biopsy cores positive, and\u002For PSA \\>10 ng\u002FmL prior to starting androgen deprivation therapy (ADT).\n\n   If a participant is taking 5-alpha reductase inhibitors the measured PSA may be doubled).\n2. Node negative by conventional imaging.\n3. Be ≥ 18 years of age on the day of signing informed consent.\n4. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 185 days prior to registration; Please note: baseline PSA must be obtained prior to the start of any ADT.\n5. ECOG performance status 0-2.\n\nExclusion Criteria:\n\n1. Diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe RT.\n2. Prior prostatectomy, cryosurgery, or HIFU for adenocarcinoma of the prostate\n3. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields\n4. Distant metastatic disease on conventional imaging, which by the discretion of the treating physician cannot be treated definitively.","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer.",[26],"Advanced Prostate Cancer","RECRUITING","2026-08-20",{"date":30,"type":31},"2026-08-21","ACTUAL",{"date":33,"type":31},"2024-06-27",{"date":35,"type":20},"2027-09-01",{"name":37,"class":38},"M.D. Anderson Cancer Center","OTHER",1,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":4,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":39},"100191818","molecular-testing-for-the-md-anderson-cancer-center-personalized-cancer-therapy-program-100191818","NCT01772771","Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program","Inclusion Criteria:\n\n* Patients must have histologically, radiographic, or cytologically documented cancer, suspected glioma, sarcoma, melanoma or hematologic cancer. Patients with benign tumors may also be consented at the discretion of the attending physician if molecular profiling is felt to have potential clinical implications.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document\n* Patients may be consented without confirming the amount and quality of archival diagnostic or residual tissue available. However, research testing will only be performed on patients who have sufficient archived diagnostic tissue or residual tissue banked in one of the authorized tissue banks at MD Anderson available to proceed with testing. The extent of testing may be modified based on amount of tissue available. If any new tissue acquisition including a biopsy and\u002For surgical resection etc. is being ordered for clinical care or another research study, or an operation is being performed testing can be ordered on that sample\n* Circulating cell-free deoxyribonucleic acid (cfDNA) Cohort: Circulating cell-free DNA next generation sequencing (NGS) testing will be performed with the Clinical Laboratory Improvement Act (CLIA)-certified Guardant360 panel (or equivalent) for select patients. This particular cohort of research collaboration will be supported by Guardant Health, Inc. at no charge to MD Anderson. Patients who are being considered for enrollment into clinical trials in the next 2 lines of therapy may be enrolled. Selected patients may have cfDNA, circulating RNA \u002Fexosome\u002Fcirculating tumor cell testing approaches performed on alternate platforms (eg Foundation ACT)",{"count":47,"type":20},12000,"OBSERVATIONAL","This study performs standardized testing of tumor tissue samples to learn which genes are mutated (have changed) in order to provide personalized cancer therapy options to cancer patients at MD Anderson. This may help doctors use testing information on tumors to identify clinical trials that may be most relevant to patients. Researchers may also use the information learned from this study to develop a database of the different kinds of mutations in cancer-related genes.",[51,52,53,54,55],"Glioma","Hematopoietic and Lymphoid Cell Neoplasm","Malignant Solid Neoplasm","Melanoma","Sarcoma",{"date":30,"type":31},{"date":58,"type":31},"2012-03-01",{"date":60,"type":20},"2033-03-01",{"name":37,"class":38},{"id":63,"slug":64,"hasResults":12,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":39},"100652853","phase-1-study-of-monzosertib-in-patients-with-rr-aml-or-high-risk-myelodysplastic-syndrome-100652853","NCT07780565","Study of Monzosertib In Patients With R\u002FR AML Or High-Risk Myelodysplastic Syndrome","Phase 1b Study of Monzosertib In Patients With Relapsed Or Refractory Acute Myeloid Leukemia Or High-Risk Myelodysplastic Syndrome","Inclusion Criteria:\n\n1. Patients need to be adults ≥18 years with R\u002FR AML, 'MDS\u002FAML', MDS, or CMML, per the ICC 2022 or the WHO 2022 with ≥5% blasts at screening. 6,7\n2. Relapsed or refractory disease is defined as: patient having received and have progressed or relapsed or intolerant to standard regimens, e.g., as listed in NCCN guidelines, or declined treatment with such therapies.\n\n   a. This may include at least one cycle of intensive chemotherapy for AML, or for AML\u002FMDS\u002FCMML at least 2 cycles of BCL2 inhibitor based lower intensity regimen or 4 cycles of HMA-based regimens without BCL2 inhibitor, or clear progression during such treatment.\n3. \"Treated secondary AML\" i.e., patients with antecedent hematological disorder, e.g., MDS, CMML, MPD\u002FMPN, who progress to AML despite receiving treatment adequate for AML (per NCCN) for the antecedent hematological disorder, will be eligible due to recognized poor outcomes similar to R\u002FR AML.\n\n   8,9\n4. Patients with actionable mutations with available FDA-approved therapies, e.g., FLT3, IDH1\u002F2, menin inhibitors may be enrolled after they have exhausted or ineligible for appropriate lines of FDA approved treatment options.\n5. ECOG PS 0 to 2\n6. Adequate hepatic function (total bilirubin ≤ 1.5 x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and\u002For ALT ≤ 2.5 x ULN unless considered due to leukemic involvement, in which case total bilirubin or AST and\u002For ALT ≤ 3 x ULN will be considered eligible).\n7. Adequate renal function with creatinine clearance ≥ 30 mL\u002Fmin calculated by the CockcroftGault formula or MDRD equation.\n8. Patients relapsing after allo-SCT may be eligible if they have recovered from all transplantrelated toxicities and are off all immunosuppression, with no more than grade 1 chronic GVHD. Physiologic (\"replacement\") dose of steroids (≤10 mg prednisone or equivalent) may be acceptable. Patients must be off all immunosuppression, including calcineurin inhibitors, for at least 2 weeks or 5 half-lives, whichever is longer, prior to enrollment on study.\n9. The effects of these agents on the developing human fetus are unknown. For this reason, and because other therapeutic agents used in this trial may be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 90 days after last treatment.\n\n   a. This includes all female patients between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: i. Postmenopausal (no menses in greater than or equal to 12 consecutive months). ii. History of hysterectomy or bilateral salpingo-oophorectomy. iii. Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range, who have received whole pelvic radiation therapy). iv. History of bilateral tubal ligation or another surgical sterilization procedure.\n\n   b. Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), tubal ligation or hysterectomy, subject\u002Fpartner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n10. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patient has a white blood cell count \\> 15 x 10⁹\u002FL. Hydroxyurea, and\u002For cytarabine use as supportive care is permitted to meet this criterion.10\n2. Prior use of any cytotoxic chemotherapy, targeted therapy, immunotherapy, or investigational therapies within 2 weeks or 5 half-lives (whichever is shorter), prior to first dose of study treatment. Patients should have recovered from all prior therapy related toxicities. Patients may receive hydroxyurea or cytarabine for control of WBC count during this washout period.\n3. Patient has uncontrolled systemic fungal, bacterial, viral or other infection with ongoing signs\u002Fsymptoms despite appropriate treatment.\n4. Decompensated congestive heart failure, clinically significant, uncontrolled arrhythmia prolonged QT interval corrected for heart rate (QTcF) to greater than 450 msec, or long QT syndrome, or history of Torsades de pointes. Patients with bundle branch block or pacemaker and prolonged QTc interval are permitted after appropriate correction, (e.g., Bogossian formula, or others) or after discussion with the PI and\u002For cardiologist. Acute respiratory failure, unstable or decompensated pulmonary disease\n5. Patients with any severe gastrointestinal or metabolic condition or gastric bypass, which could interfere with absorption of oral drug.\n6. Active hepatitis B (HBV) or Hepatitis C (HCV) infection with detectable viral DNA or RNA, respectively, or known HIV infection. Patients with history of hepatitis with undetectable viral load will be eligible.\n7. Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator.\n8. Any previous malignancy, except when the patient has completed definitive curative-intent treatment with chemotherapy and\u002For surgery and\u002For radiotherapy at least 1 month prior to enrollment. Patients having completed definitive treatment for the following conditions may be eligible immediately after completion of definitive curative-intent therapy, after healing of wounds, and no evidence of residual disease by examination or imaging or cytology\u002Fpathology, e.g., non-melanoma skin cancers, or any carcinoma in-situ, e.g., ductal carcinoma in situ, urothelial cancer, cervical cancer, localized prostate cancer, pre-cancerous colon polyp, etc.\n9. Major surgery within 4 weeks prior to screening or a major wound that has not fully healed.\n10. Patients under legal protection measure (guardianship, trusteeship or safeguard of justice) and\u002For uncontrolled psychiatric comorbidities, ongoing illicit substance abuse, inability, any impairment or unwillingness to comply with the treatments, follow-up, requirements and procedures of this clinical trial.\n11. Nursing women, women of childbearing potential (WOCBP) with positive urine or serum pregnancy test, or WOCBP who are not willing to maintain adequate contraception.\n12. Pregnant women are excluded from this study because study agents may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated on this study.",{"count":70,"type":20},42,[72],"PHASE1","The goal of this clinical research study is to find the recommended dose of monzosertib in patients with relapsed\u002Frefractory AML and high-risk MDS. The safety and effects of monzosertib will also be studied.",[75,76],"Acute Myeloid Leukemia (AML)","Myelodysplastic Syndrome","NOT_YET_RECRUITING","2026-08-19",{"date":30,"type":31},{"date":81,"type":20},"2027-01-01",{"date":83,"type":20},"2031-08-30",{"name":37,"class":38},{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":48,"phases":4,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100455038","trans-pacific-multicenter-collaborative-study-of-minimally-invasive-proximal-versus-total-gastrectomy-for-proximal-gastric-and-gastroesophageal-junction-cancers-100455038","NCT05205343","Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers","Inclusion:\n\n1. Able to speak and read English, Spanish, Japanese or Korean\n2. Participants with a biopsy-confirmed diagnosis of non-metastatic gastric or GEJ adenocarcinoma, who are scheduled to undergo MIPG or MITG for curative-intention\n3. Age ≥ 18\n\nExclusion:\n\n1. Participants with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract\n2. Participants with known narcotic dependence, with average daily dose \\> 5 mg oral morphine equivalent\n3. Participants deemed unable to comply with study and\u002For follow-up procedures, at investigators' discretion\n4. Participants who are pregnant (since are excluded from receiving standard-of-care MIPG or MITG)",{"count":92,"type":20},20,"To compare the symptoms of patients who have a MIPG to the symptoms of patients who have a MITG.",[95,96,97],"Gastrostomy","Gastric","GastroEsophageal Cancer",{"date":30,"type":31},{"date":100,"type":31},"2022-05-11",{"date":102,"type":20},"2028-05-31",{"name":37,"class":38},4,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":39},"100336506","phase-1-quizartinib-decitabine-and-venetoclax-in-treating-participants-with-untreated-or-relapsed-acute-myeloid-leukemia-or-high-risk-myelodysplastic-syndrome-100336506","NCT03661307","Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome","A Phase I\u002FII Study of Quizartinib in Combination With Decitabine and Venetoclax for the Treatment of Patients With Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Diagnosis of 1) AML (World Health Organization \\[WHO\\] classification definition of \\>= 20% blasts) excluding acute promyelocytic leukemia (APL) or 2) MDS with \\> 10% blasts (defined by the International Prognostic Scoring System \\[IPSS\\] classification).\n* For frontline Cohort: Patients aged \\>= 60 years old who are not candidates for intensive induction therapy and agree to receive the proposed combination therapy will be enrolled.\n* Not considered candidates for intensive remission induction chemotherapy at time of enrollment based on EITHER:\n\n  * 75 years of age OR\n  * \\\u003C 75 years of age with at least 1 of the following:\n\n    * Poor performance status (Eastern Cooperative Oncology Group \\[ECOG\\]) score of 2-3.\n    * Clinically significant heart or lung comorbidities, as reflected by at least 1 of:\n\n      * Left ventricular ejection fraction (LVEF) =\\\u003C 50%.\n      * Lung diffusing capacity for carbon monoxide (DLCO) =\\\u003C 65% of expected.\n      * Forced expiratory volume in 1 second (FEV1) =\\\u003C 65% of expected.\n      * Chronic stable angina or congestive heart failure controlled with medication.\n  * Liver transaminases \\> 3 x upper limit of normal (ULN).\n  * Other contraindication(s) to anthracycline therapy (must be documented).\n  * Other comorbidity the investigator judges incompatible with intensive remission induction chemotherapy, which must be documented and approved by the principal investigator (PI).\n* Patients with newly diagnosed AML with poor risk complex karyotype and\u002For TP53 deletions\u002Fmutations equal or younger than 60 year old\n* For relapsed cohort: Patients aged \\>= 18 years old. (Patients who are candidates for relapse cohort will be enrolled into the study regardless of their fitness for intensive chemotherapy). (a) Patients with relapsed\u002Frefractory AML are eligible if they are not eligible for potentially curative therapy such as effective salvage therapy or hematopoietic stem cell transplantation or who refuse these options at the time of enrollment.\n* Detection of FLT3-ITD mutation or FLT3-ITD\u002FTKD co-mutations in bone marrow and\u002For peripheral blood samples within 30 days prior to study enrollment.\n* For frontline cohort: Patients must be chemonaive, i.e. not have received any chemotherapy (except hydrea or 1-2 doses of ara-C for transient control of hyperleukocytosis) for AML or MDS. They may have received transfusions, hematopoietic growth factors or vitamins for an antecedent hematological disorder (AHD) or for AML. Temporary prior measures such as apheresis, all-trans-retinoic acid (ATRA), steroids or hydrea while diagnostic work-up is being performed are allowed and not counted as a prior salvage. Supportive care therapy for MDS (growth factors, transfusions) will not be considered as prior therapy for MDS\u002FAML and these patients will be enrolled to the frontline cohort of the study if they are otherwise eligible.\n* For relapsed cohort: Patients who have received at least one prior therapy for AML or for MDS with \\> 10% blasts will be eligible. Patients may have received up to 4 prior salvages for AML and\u002For MDS (defined by the IPSS classification). Prior therapy for AML or MDS will be counted as a prior salvage. Patients who receive MDS directed therapies considered not purely supportive such as HMAs, lenalidomide, investigational therapies, will be enrolled to the salvage cohort if they are otherwise eligible.\n* In the absence of rapidly progressing disease, the interval from prior treatment to time of initiation of protocol therapy will be at least 2 weeks for cytotoxic agents or at least 5 half-lives for cytotoxic\u002Fnoncytotoxic agents. The half-life for the therapy in question will be based on published pharmacokinetic literature (abstracts, manuscripts, investigator brochure's, or drug-administration manuals) and will be documented in the protocol eligibility document\n* The use of chemotherapeutic or anti-leukemic agents is not permitted during the study with the following exceptions: (1) intrathecal (IT) therapy for patients with controlled central nervous system (CNS) leukemia at the discretion of the PI a (2) Use of one dose of cytarabine (up to 2 g\u002Fm\\^2) or hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy. These medications will be recorded in the case-report form.\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2.\n* Serum biochemical values with the following limits unless considered due to leukemia, hemolysis or congenital disorder (creatinine \\\u003C 1.8 mg\u002Fdl, total bilirubin \\\u003C 1.8 mg\u002FdL, \\[serum glutamate pyruvate transaminase (SGPT)\\] \\\u003C 2.5 x upper limit of normal).\n* White blood cell count \\\u003C 25 x 10\\^9\u002FL\n* Potassium, magnesium, and calcium (normalized for albumin) levels should be within institutional normal limits.\n* Ability to take oral medication.\n* Ability to understand and provide signed informed consent.\n* Baseline left ventricular ejection fraction by echocardiogram (ECHO) or multigated acquisition (MUGA) \\>= 50%.\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.\n* WOCBP must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy until at least 3 months after the last dose of investigational drug. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as men with azoospermia do not require contraception.\n* Negative urine or serum pregnancy test.\n* Investigational agents that are not used for treatment of the leukemia per se (e.g. anti-infective prophylaxis or therapy) will be allowed. Other supportive care studies are allowed, even if under an Investigational New Drug (IND).\n\nExclusion Criteria:\n\n* Patients with known allergy or hypersensitivity to quizartinib, mannitol, decitabine or any of their components.\n* Prior quizartinib use.\n* Patients with known uncontrolled CNS leukemia.\n* Only for frontline cohort: patients who are fit for intensive chemotherapy.\n* Patients with electrolyte abnormalities at study entry defined as follows: Serum potassium \\\u003C 3.5 mEq\u002FL despite supplementation, or \\> 5.5 mEq\u002FL Serum magnesium above or below the institutional normal limit despite adequate management. Serum calcium (corrected for albumin levels) above or below institutional normal limit despite adequate management.\n* Patients with known significant impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of quizartinib.\n* Patients with any other known concurrent severe and\u002For uncontrolled medical condition including but not limited to diabetes, cardiovascular disease including hypertension, renal disease, or active uncontrolled infection, which could compromise participation in the study. Patients on active antineoplastic or radiation therapy for a concurrent malignancy at the time of screening. Maintenance therapy, hormonal therapy, or steroid therapy for well-controlled malignancy is allowed.\n* Patients with a known human immunodeficiency virus (HIV) infection.\n* Patients with known positive hepatitis B or C infection by serology, with the exception of those with an undetectable viral load within 3 months. (Hepatitis B or C testing is not required prior to study entry). Subjects with serologic evidence of prior vaccination to HBV \\[i.e., hepatitis B surface antigen \\[HBs Ag\\]-, and anti-HBs+\\] may participate.\n* Patients who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment.\n* Patients who have had any major surgical procedure within 14 days of day 1.\n* Impaired cardiac function including any of the following: Screening ECG with a Fridericia's correction formula (QTcF) \\> 450 msec. The QTcF interval will be calculated by Fridericia's correction factor (QTcF). The QTcF will be derived from the average QTcF in triplicate. Patients are excluded if they have QTcF \\>= 450. Subjects with prolonged QTcF interval in the setting of RBBB (right bundle branch block) may participate upon review and approval by the medical monitor. RBBB for patients' triplicate EKGs can show false corrected QT (QTc) prolongation; therefore, the Cardiology collaborator for this study will manually review to provide an accurate reading of the QTc. Patients with congenital long QT syndrome. History or presence of sustained ventricular tachycardia requiring medical intervention. Any history of clinically significant ventricular fibrillation or torsades de pointes. Known history of second or third degree heart block (may be eligible if the patient currently has a pacemaker). Sustained heart rate of \\\u003C 50\u002Fminute on pre-entry ECG. Right bundle branch block + left anterior hemiblock (bifascicular block). Complete left bundle branch block. Patients with myocardial infarction or unstable angina within 6 months prior to starting study drug. Congestive heart failure (CHF) New York (NY) Heart Association class III or IV. Atrial fibrillation documented within 2 weeks prior to first dose of study drug. Patients who are actively taking a strong CYP3A4 inducing medication.\n* Patients who require treatment with concomitant drugs that prolong QT\u002FQTc interval or strong CYP3A4 inhibitors with the exception of antibiotics, antifungals, and antivirals that are used as standard of care to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject or if the Investigator believes that beginning therapy with a potentially QTc-prolonging medication (such as anti-emetic except for prochlorperazine) is vital to an individual subject's care while on study.\n* Known family history of congenital long QT syndrome.\n* Patients who are on strong CYP3A4 inhibitor will be excluded.",{"count":113,"type":20},73,[72,23],"This phase I\u002FII trial studies how well quizartinib, decitabine, and venetoclax work in treating participants with acute myeloid leukemia or high risk myelodysplastic syndrome that is untreated or has come back (relapsed). Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving quizartinib and decitabine may work better at treating acute myeloid leukemia and myelodysplastic syndrome.",[117,76,118,119,120],"Acute Myeloid Leukemia","Recurrent Acute Myeloid Leukemia","Recurrent Myelodysplastic Syndrome","Refractory Acute Myeloid Leukemia",{"date":28,"type":31},{"date":123,"type":31},"2018-10-31",{"date":125,"type":20},"2028-01-01",{"name":37,"class":38},{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":39},"100245918","phase-2-cytotoxic-t-lymphocytes-in-treating-patients-with-malignancies-with-bk-andor-jc-virus-100245918","NCT02479698","Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and\u002For JC Virus","Phase II Study Assessing the Effect of BK Specific CTL Lines Generated by Ex Vivo Expansion in Patients With BK Virus Infection and JC Virus Infection","Inclusion Criteria:\n\n* Patients ≥ 2 years.\n* English and non-English speaking patients are eligible.\n* Immunocompromised patients including but not limited to those with any type of malignancy, HIV\u002FAIDS, or history of solid organ transplant\n* Non-immunocompromised patients with PML\u002FJC virus encephalitis\n* Microscopic or greater hematuria urine or blood PCR positive for BK virus\n* Biopsy proven BK nephritis and urine or blood PCR positive for BK virus disease and\u002For polyomavirus.\n* Definite or probable PML\u002FJC viral encephalitis (see Appendix C)\n* JC end-organ disease\n* Receiving \\> 6 mg \u002F day of prednisone or equivalent at the time of enrollment.\n* Patients with BK virus hemorrhagic cystitis, who are receiving treatment with cidofovir, leflunomide, or other antiviral therapy with no response, will be eligible for CTL infusion.\n* Patients with JCV encephalitis \u002F PML may be receiving pembrolizumab.\n* Written informed consent and\u002For signed assent from patient, parent or guardian.\n* Patients with cognitive impairments are eligible.\n* A negative pregnancy test in female patients of childbearing potential. Childbearing potential is defined as pre-menopausal, post-menopausal for \\\u003C 1 year, and not having undergone surgical sterilization.\n* Women of childbearing potential must be willing to use an effective contraceptive measure while on study.\n* Patients enrolled on this study may be enrolled on other IND studies at the discretion of the PI.\n* Patients with bacterial infections must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment.\n* Patients with fungal infections patients must be receiving definitive systemic anti fungal therapy and have no signs of progressing infection for 1 week prior to enrollment.\n* Patients may be re-enrolled in the protocol if the BK or JC virus infection recurs, so long as they meet all the other eligibility criteria at the time of re-enrollment.\n\nExclusion Criteria:\n\n* Patients receiving \\> 6 mg \u002F day of prednisone or equivalent at time of\n* Patients who have received ATG within 14 days of enrollment\n* Patients who have received donor lymphocyte infusion (DLI) within 28 days of enrollment.\n* Patients who have received alemtuzumab within 28 days of enrollment.\n* Patients with other uncontrolled infections (including HIV\u002FAIDS). Uncontrolled infection is defined as the presence of hemodynamic instability attributable to sepsis, or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as uncontrolled infection.\n* Patients with active acute GVHD grades II-IV.",{"count":19,"type":20},[23],"This phase II trial studies how well donor cytotoxic T lymphocytes work in treating patients with malignancies with BK and\u002For JC virus. Cytotoxic T lymphocytes are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections in transplant patients and may be an effective treatment in patients with malignancies with BK and\u002For JC virus.",[138,139,140,141,142,143,144,145],"Acquired Immunodeficiency Syndrome","BK Virus Infection","Human Immunodeficiency Virus","JC Virus Infection","Malignant Neoplasm","Merkel Cell Carcinoma","Merkel Cell Polyomavirus Infection","Viral Encephalitis",{"date":30,"type":31},{"date":148,"type":31},"2015-07-23",{"date":150,"type":20},"2027-07-31",{"name":37,"class":38},{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":39},"100641128","phase-2-pilot-study-of-ivonescimab-in-advancedmetastatic-cutaneous-angiosarcoma-100641128","NCT07655570","Pilot Study of Ivonescimab in Advanced\u002FMetastatic Cutaneous Angiosarcoma","Inclusion Criteria:\n\n* Patients must have histologically confirmed cutaneous angiosarcoma that is advanced, metastatic or unresectable.\n* Patients must have received prior paclitaxel or docetaxel containing therapy.\n* Patients must have measurable disease within 28 days of starting treatment, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, PET or calipers by clinical exam\u002Fmedical photography.\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of ivonescimab in patients \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status ≤1 (Karnofsky ≥60%,).\n* Patients must have adequate organ and marrow function as defined below (see Schedule of Activities) :\n\nAbsolute neutrophil count ≥1,500\u002FmcL Platelets ≥100,000\u002FmcL Hemoglobin ≥ 9.0 g\u002FdL Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). For patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤3 × ULN AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional ULN. For patients with liver metastases, AST and ALT ≤ 5 × ULN.\n\nCreatinine clearance (CrCl) ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥50 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation Urine protein \\\u003C 2+ or 24 hour urine protein quantification \\\u003C 1.0 g Coagulation Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 x ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy, or prophylactic coagulation). Patients receiving therapeutic anti-coagulation should be on a stable dose.\n\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for one month prior to enrollment .\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 3 months.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen per PI are eligible for this trial.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class NYHA classification 2B or better.\n* The effects of ivonescimab on the developing human fetus are unknown. For this reason and because anti-PD-1 and anti-VEGFA agents have the potential to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation up to 120 days after last dose of ivonescimab. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 120 days after the last dose of ivonescimab. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 120 days after the last dose of ivonescimab.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Consent to MD Anderson companion laboratory protocol 2014-0938 for correlative analyses of biopsies obtained in this trial.\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (residual toxicities that are \\> Grade 2 by CTCAE v 5.0) with the exception of alopecia.\n* Patients who are receiving any other investigational agents.\n* Patients who have received prior immune checkpoint inhibitors (anti-PD-1 or anti-PD-L1 drugs).\n* Symptomatic CNS metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to enrollment, potential need for CNS radiation within the first cycle, or leptomeningeal disease.\n\nNote: Patients must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).\n\n* Active autoimmune or lung disease requiring systemic therapy (eg, with disease modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to enrollment, however the following will be allowed:\n\n  1. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n  2. Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted\n* Current use of systemic corticosteroids (\\>10 mg daily prednisone or equivalent)\n* Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ivonescimab (immune checkpoint inhibition antibodies, antiangiogenic antibodies).\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE v5.0\n* Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic Note: Patients managed with indwelling catheters (eg, PleurX) are allowed\n* History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ivonescimab, breastfeeding should be discontinued if the mother is treated with ivonescimab. These potential risks may also apply to other agents used in this study.\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to enrollment, including but not limited to:\n\n  * Gastrointestinal bleeding\n  * Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots) Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n  * Nasal bleeding \u002Fepistaxis (bloody nasal discharge is allowed)\n* Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to enrollment is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.\n* Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Current hypertension with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n* Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to enrollment, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia).\n* Patients with acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before enrollment.\n* Major surgical procedures or serious trauma within 4 weeks prior to enrollment or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to enrollment.\n* Patients with a history of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to enrollment.\n* Patients with a history of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before enrollment.\n* Patients with a history of arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to enrollment.\n* Imaging during the 28-day screening period shows that the patient has:\n\n  * Radiologically documented evidence of major blood vessel invasion or encasement by cancer\n  * Radiographic evidence of intratumor cavitation\n* Live vaccine or live attenuated vaccine within 4 weeks prior to planned enrollment, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted.\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n* Severe infection within 4 weeks prior to enrollment, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to enrollment (excluding antiviral therapy for hepatitis B or C).\n* History or current evidence of any condition (medical \\[including adverse events from prior anticancer therapy, disorders secondary to tumor\\], surgical or psychiatric \\[including substance abuse\\]), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, might lead to higher medical risk and\u002For is not in the best interest of the patient to participate, in the opinion of the treating investigator",{"count":159,"type":20},10,[23],"This is a pilot study evaluating the efficacy and safety of ivonescimab in subjects with advanced or metastatic cutaneous angiosarcoma who have previously been treated with taxane-based chemotherapy.",[163],"Cutaneous Angiosarcoma","2026-08-18",{"date":28,"type":31},{"date":167,"type":20},"2026-11-30",{"date":169,"type":20},"2029-05-11",{"name":37,"class":38},{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":39},"100617948","phase-2-a-pilot-study-to-correlate-4-18f--fluoro-1-naphthol-18f-4fn-petct-imaging-with-chronic-graft-versus-host-disease-manifestations-100617948","NCT07325253","A Pilot Study to Correlate 4-18F- Fluoro-1-naphthol 18F-4FN PET\u002FCT Imaging With Chronic Graft Versus Host Disease Manifestations","Eligibility Criteria\n\n1. Chronic GVHD involving the joints, defined as any limitation of range of motion measured by Photographic Range Of Motion (PROM). Criteria can be found at (Jagasia, et al. 2015).\n2. Able to give written informed consent.\n3. ≥18 years of age\n4. Creatinine clearance ≥ 30 mL\u002Fmin\u002F1.73m2\n5. Non-joint chronic GVHD diagnostic \u002F distinctive features are allowed.\n6. Subjects may be planned to receive a new systemic therapy for chronic GVHD\n7. Prior\u002Fcontinuing systemic therapy for chronic GVHD is allowed\n8. KPS ≥ 20\n9. Ability to understand and the willingness to sign a written informed consent document.\n10. The effects of the study agent on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n    * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n    * History of hysterectomy or bilateral salpingo-oophorectomy.\n    * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n    * History of bilateral tubal ligation or another surgical sterilization procedure.\n\n      * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n11. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study agent administration.\n\nExclusion Criteria\n\n1. Unable to comply with all study procedures (for example, participants who are unable to come to all follow up visits because they live far away from the transplant center)\n2. Pregnant or lactating women: pregnant women are excluded from this study because the effects of \\[18F\\]4FN in pregnancy are not known.\n3. Subjects with contraindications to the use of \\[18F\\]4FN including confirmed allergy.\n4. Participants with a body weight of 400 pounds or more, or a body habitus which precludes their entry into the bore of the PET\u002FCT scanner, because the hardware is not intended to support that weight.\n5. Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.\n6. Children below the age of 18 are excluded because of the unknown but potential risks of administration of radiopharmaceuticals to minors.",{"count":178,"type":20},16,[23],"To study the safety and possible side effects of using the imaging agent 4-\\[18F\\]Fluoro-1-Naphthol (also called \\[18F\\]4FN) in PET\u002FCT scans for participants with chronic GVHD.",[182,183,184],"Pilot Study","PET\u002FCT Imaging","Host Disease Manifestation",{"date":28,"type":31},{"date":187,"type":31},"2025-11-18",{"date":189,"type":20},"2030-01-03",{"name":37,"class":38},{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":21,"phases":198,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":39},"100614756","phase-2-phase-2-trial-of-zanzalintinib-and-pembrolizumab-in-select-subtypes-of-advancedmetastatic-soft-tissue-sarcoma-100614756","NCT07283731","Phase 2 Trial of Zanzalintinib and Pembrolizumab in Select Subtypes of Advanced\u002FMetastatic Soft-tissue Sarcoma","Eligibility Criteria\n\n* Participants must have histologically or cytologically confirmed undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma (MFS), high grade pleomorphic (HGPS) or undifferentiated sarcoma (HGUS).\n* Participant ≥ 18 years of age. Because no dosing or adverse event data are currently available on the use of zanzalintinib in combination with pembrolizumab in participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status ≤2 (Karnofsky ≥60%).\n* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.\n* At least 4 weeks since prior chemotherapy.\n* At least 2 weeks since radiation therapy for bone metastases, any other radiation therapy within 4 weeks before first dose of study treatment. At least 6 weeks since systemic treatment with radionuclides before first dose of study treatment.\n* Participants must have adequate organ and marrow function as defined below within 14 days before first dose of study treatment:\n\nabsolute neutrophil count ≥1,500\u002FmcL without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection.\n\nplatelets ≥100,000\u002FmcL without transfusion within 2 weeks of screening laboratory sample collection.\n\nhemoglobin ≥ 9 g\u002FdL (≥ 90 g\u002FL) without transfusion within 2 weeks prior to screening laboratory sample collection.\n\ninternational normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN ).\n\ntotal bilirubin ≤ 1.5 x institutional ULN AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN Alkaline phosphatase (ALP) ≤3 × institutional ULN, . For subjects with documented bone metastasis ALP ≤ 5 x ULN.\n\ncreatinine ≤ 1.5 x institutional ULN or calculated creatinine clearance ≥ 40 mL\u002Fmin (≥ 0.67 mL\u002Fsec) using the Cockcroft Gault equation.\n\nUrine protein-to-creatinine ratio (UPCR) ≤ 1 mg\u002Fmg (≤ 113.2 mg\u002Fmmol)\n\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 4 weeks. Note: Participants must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).\n* Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first three cycles of therapy.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* The effects of zanzalintinib and pembrolizumab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n  o Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n\n  o History of hysterectomy or bilateral salpingo-oophorectomy.\n\n  o Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n\n  o History of bilateral tubal ligation or another surgical sterilization procedure.\n\n  o Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n* Females must not be pregnant.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal ligation or hysterectomy, subject\u002Fpartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Women of childbearing potential must comply for the duration of study participation and through 186 days after the last dose of zanzalintinib and 180 days after the last dose of pembrolizumab, whichever date is later. Men must comply for the duration of study participation and through 96 days after the last dose of zanzalintinib or 96 days of pembrolizumab, whichever date is later.\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.\n* Consent to MD Anderson companion laboratory protocol 2014-0938 for correlative analyses of biopsies obtained in this trial.\n\nExclusion Criteria\n\n* Prior treatment with immune checkpoint inhibitors (ICIs)\n* Prior treatment with zanzalintinib\n* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n* Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible. Additionally, if participants have received radiation therapy within 4 weeks or systemic therapy with radionucleotides within 6 weeks they are not eligible.\n* Participants who are receiving any other investigational agents, as well as cytotoxic or biological systemic anticancer therapy including investigational treatments within 4 weeks of initiating study treatment are excluded.\n* Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin inhibitors) and platelet inhibitors (eg, clopidogrel).\n\n  * Allowed anticoagulants are the following:\n\n    1. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n    2. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\nNote: Subjects must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer.\n\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\nUnstable of deteriorating cardiovascular disorders • Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (eg, ventricular flutter, ventricular fibrillation, Torsade's de pointes).\n\n* Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment.\n* Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction, or other clinically significant arterial thrombotic and\u002For ischemic event within 6 months before first dose of study treatment.\n* Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before first dose of study treatment.\n\nNote: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\nNote: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator.\n\no Prior history of myocarditis.\n\nGastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n\n* Tumors invading the GI-tract from external viscera.\n* Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis.\n* Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before first dose unless cause of obstruction is definitively managed and subject is asymptomatic.\n* Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n* Known gastric or esophageal varices.\n* Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks.\n\n  * Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose of study treatment.\n  * Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed).\n  * Tumors invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. Note: Subjects with intravascular tumor extension (eg, tumor thrombus in renal vein or inferior vena cava) may be eligible following Principal Investigator approval.\n  * Other clinically significant disorders that would preclude safe study participation.\n* Active infection requiring systemic treatment. Note: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are allowed.\n* Serious non-healing wound\u002Fulcer\u002Fbone fracture. Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.\n* Malabsorption syndrome.\n* Pharmacologically uncompensated, symptomatic hypothyroidism.\n* Moderate to severe hepatic impairment (Child-Pugh B or C).\n* Requirement for hemodialysis or peritoneal dialysis.\n* History of solid organ or allogeneic stem cell transplant.\n\n  * Participants with brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 3 months.\n  * History of allergic reactions attributed to compounds of similar chemical or biologic composition to zanzalintinib or pembrolizumab or other agents used in study.\n  * Moderate or strong CYP3A4 inhibitors (see section 5.4).\n  * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load and CD4+ T cell count ≥ 200\u002FµL within 6 months are eligible for this trial.\n* Note: To be eligible, participants taking CYP inhibitors (eg, zidovudine, ritonavir, cobicistat, didanosine) or CYP3 inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies (ART) must have been received for at least 4 weeks prior to the first dose. Note: CD4+ T cell counts, and viral load are monitored per standard of care by the local health care provider.\n\n  * Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n  * Pregnant women are excluded from this study because zanzalintinib has the potential for teratogenic or abortifacient effects based on its mechanism of action. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with zanzalintinib and pembrolizumab, breastfeeding should be discontinued if the mother is treated with either agent. These potential risks may also apply the other agents used in this study.\n  * Major surgery (as defined in Appendix 2) within 8 weeks prior to first dose of study treatment. Prior laparoscopic surgeries (ie nephrectomy) within 4 weeks prior to first dose of study treatment. Minor surgery (eg, simple excision, tooth extraction) within 5 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment.\n\nNote: Fresh tumor biopsies should be performed at least 5 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.\n\n• Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment.\n\nNote: Triplicate ECG evaluations one minute apart will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility.\n\n* Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube.\n* Another malignancy that requires active therapy and in the opinion of the Investigator would interfere with monitoring of radiologic assessments of response to Investigational Product, within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n* Suspected autoimmune disease, or active or prior documented autoimmune disease within the last 2 years.\n\nNote: Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n\n* Known positive test for tuberculosis infection if supported by clinical or radiographic evidence of disease.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computerized tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Free thyroxine (FT4) outside the laboratory normal reference range. Asymptomatic subjects with FT4 abnormalities can be eligible after Principal Investigator approval.\n* Diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\> 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment. Inhaled, intranasal, intraarticular, and topical corticosteroids and mineralocorticoids are allowed. Note: Adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. Transient short-term use of higher doses of systemic corticosteroids for allergic conditions (eg, contrast allergy) is also allowed.\n* Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.\n* Other conditions, which in the opinion of the Investigator, would compromise the safety of the participant or the participant's ability to complete the study.",{"count":92,"type":20},[23],"To learn if zanzalintinib and pembrolizumab can help to control select subtypes of advanced\u002Fmetastatic soft-tissue sarcoma (UPS, MFS, HGPS, and HGUS",[201,202,203,204,205],"Phase 2","Zanzalintinib","Pembrolizumab","Advanced\u002FMetastatic","Soft-Tissue Sarcoma",{"date":28,"type":31},{"date":208,"type":31},"2026-04-14",{"date":210,"type":20},"2030-11-01",{"name":37,"class":38},{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":21,"phases":220,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":39},"100614754","phase-2-a-phase-ii-study-evaluating-bms-986504-in-mtap-deleted-pancreatic-cancer-100614754","NCT07283705","A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer","Eligibility Criteria\n\n* Age ≥18 years.\n* Homozygous MTAP deletion detected by NGS. Test can be performed on an archival tissue collected within 6 months from study enrollment and on blood samples.\n* ECOG performance status 0-1.\n* Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC)\n* Adequate organ and marrow function as defined below\n\n  * Hemoglobin ≥9.0 g\u002FdL with no packed red blood cell transfusions in the past 7 days.\n  * Absolute neutrophil count (ANC) ≥1.5 x 10⁹\u002FL.\n  * Platelet count ≥100 x 10⁹\u002FL with no platelet transfusions in the past 7 days.\n  * Total bilirubin ≤1.5 x institutional upper limit of normal (ULN).\n  * AST (SGOT)\u002FALT (SGPT) ≤2.5 x institutional ULN value unless liver metastases are present, in which case ≤5 x ULN.\n* Calculated creatinine clearance ≥50 mL\u002Fmin (using Cockroft-Gault formula or 24-hour urine collection).\n* Participants are allowed to have received 1 month of GA (cohort 1 and 2) and mFolfirinox (cohort 3) in consideration of the aggressive nature of PDAC and the time required for to test MTAP-deficiency\n* Agree to follow the study protocol, including treatment, scheduled visits, and examinations, for the duration of the study.\n* Ability to understand and the willingness to sign a written informed consent document.\n\n  1 Female (as assigned at birth) participants\n* Women of child-bearing potential (WOCBP) include all female participants, between the onset of menses and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114): :\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* WOCBP must agree to use a combination of a hormonal and a non-hormonal contraceptive method or a non-hormonal method alone that is highly effective (with a failure rate of \\\u003C 1% per year) during the intervention period and for at least 9 months after the last dose of study intervention, or according to approved local product label requirements for individual chemotherapy agents, whichever is longer.\n\n  * WOCBP are not permitted to use hormonal contraceptive methods alone as a highly effective method of contraception and must use an additional non-hormonal highly effective method of contraception.\n  * WOCBP participants must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period. Participants should be advised to seek advice about egg donation and cryopreservation of germ cells before treatment.\n  * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, and Implantable or injectable contraceptives. . Not engaging in sexual activity for the entire period of risk associated with the study intervention is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n    2 Male (as assigned at birth) participants\n* Male (as assigned at birth) participants will be required to always use a latex or other synthetic condom during any sexual activity (eg, vaginal, anal, oral) with WOCBP, even if the participant has undergone a successful vasectomy or if the partner is pregnant or breastfeeding. Male (as assigned at birth) participants should continue to use a condom during the intervention period and for at least 6 months after the last dose of study intervention, or according to approved local product label requirements for individual chemotherapy agents, whichever is longer.\n* Male (as assigned at birth) participants with a pregnant or breastfeeding partner must agree to remain abstinent from sexual activity or use a male condom during any sexual activity (eg, vaginal, anal, oral), even if the participant has undergone a successful vasectomy, during the intervention period and for at least 6 months after the last dose of study intervention or according to approved local product label requirements for individual chemotherapy agents, whichever is longer.\n* Male (as assigned at birth) participants must refrain from donating sperm during the intervention period and for at least 6 months after the last dose of study intervention, or according to approved local product label requirements for individual chemotherapy agents, whichever is longer. Participants should be advised to seek advice about sperm donation and cryopreservation of germ cells before treatment.\n* WOCBP partners of male (as assigned at birth) participants should be advised to use a highly effective method of contraception during the intervention period and for at least 6 months after the last dose of study intervention, or according to approved local product label requirements for individual chemotherapy agents, whichever is longer, for the male participant.\n\nCohort 1 specific criteria:\n\n* Resectable or borderline resectable pancreatic adenocarcinoma per NCCN version 3.202432 that have not received any neoadjuvant treatment\n\n  o Resectable PDAC will be defined as the tumor with:\n* No arterial tumor contact (celiac axis \\[CA\\], superior mesenteric artery \\[SMA\\], or common hepatic artery \\[CHA\\])\n* No tumor contact with the superior mesenteric vein (SMV) or portal vein (PV) or ≤180° contact without vein contour irregularity.\n* Borderline PDAC will be defined as the tumor with:\n\n  o For tumors of the pancreatic head\u002Funcinate process:\n* Solid tumor contact with CHA without extension to CA or hepatic artery bifurcation, allowing for safe and complete resection and reconstruction.\n* Solid tumor contact with the SMA of ≤180°.\n* Solid tumor contact with variant arterial anatomy (eg, accessory right hepatic artery, replaced right hepatic artery, replaced CHA, and the origin of replaced or accessory artery) and the presence and degree of tumor contact should be noted if present, as it may affect surgical planning.\n* Solid tumor contact with the SMV or PV of \\>180°, contact of ≤180° with contour irregularity of the vein or thrombosis of the vein but with suitable vessel proximal and distal to the site of involvement, allowing for safe and complete resection and vein reconstruction.\n* Solid tumor contact with the inferior vena cava (IVC).\n\n  o For tumors of the pancreatic body\u002Ftail:\n* Solid tumor contact with the CA of ≤180°\n\nCohort 2 specific criteria:\n\n* Locally advanced, unresectable pancreatic cancer per NCCN version 3.202432\n\n  o For tumors of the head\u002Funcinate process:\n* Solid tumor contact \\>180° with the SMA or CA\n* Unreconstructible SMV\u002FPV due to tumor involvement or occlusion (can be due to tumor or bland thrombus).\n\n  o For tumors of the pancreatic body\u002Ftail:\n* Solid tumor contact of \\>180° with the SMA or CA.\n* Solid tumor contact with the CA and aortic involvement.\n* No prior treatment with the exception of one month of chemotherapy with GA without progression of disease\n\nCohort 3 specific criteria:\n\n* Metastatic pancreatic adenocarcinoma.\n* No prior treatment, except one month of chemotherapy with mFOLFIRINOX without progression of disease.\n\nExclusion Criteria\n\n* Prior treatment with PRMT5 and MAT2A inhibitors.\n* Exposure to an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to trial enrolment is not permitted.\n* Participants with other primary cancers are excluded, except for adequately treated nonmelanoma skin cancer, prostate cancer post-resection with undetectable PSA, in-situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast, Stage 1 Grade 1 endometrial carcinoma, or solid tumors (including lymphomas without bone marrow involvement) curatively treated with no evidence of disease for ≥2 years prior to study entry.\n* Major surgery within 2 weeks of starting treatment is not permitted. Participants must have recovered from the effects of any major surgery.\n* Significant third-space fluid retention (e.g., ascites or peritoneal effusion) that requires drainage within 1 month prior to randomization.\n* Cardiac abnormalities including:\n\n  * Left ventricular ejection fraction \\\u003C 50%\n  * History of prolonged QTc, or QT interval corrected for heart rate using Fridericia's formula (QTcF) prolongation \\> 480 msec, except for right bundle branch block\n  * Uncontrolled\u002Fsymptomatic or significant cardiovascular conditions within 6 months prior to enrollment, including but not limited to any of the following:\n* Cardiac angioplasty or stenting, myocardial infarction, stroke\u002Ftransient ischemic attack, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, New York Heart Association (NYHA) class III-IV congestive heart failure, pericarditis, myocarditis, atrial fibrillation or other arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsade's de pointes)\n* Ongoing need for a medication with a known risk of Torsade's de Pointes or known as a strong inhibitor or strong inducer of CYP3A4 and\u002For P-glycoprotein or a proton-pump inhibitor that cannot be switched to alternative treatment prior to study entry. The following drug interaction databases and other literature can be utilized to determine the CYP3A4\u002FPgp inhibitors and inducers:\n\n  * https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-anddruginteractions- table-substrates-inhibitors-and-inducers.\n  * https:\u002F\u002Fdruginteractions.medicine.iu.edu\u002FMainTable.aspx. Note: Please consult with the Sponsor Medical Monitor for any uncertainties regarding potential CYP3A4 and P-gp modulators.\n* Active viral hepatitis, including the following:\n\n  * Any positive test result for hepatitis B virus (HBV) indicating presence of virus, e.g., HBV DNA positive would be excluded. Participants with anti-HBs positive in line with prior vaccination or resolved infection are eligible to enroll.\n  * Any positive test result for hepatitis C virus (HCV) indicating presence of active viral replication (detectable HCV RNA).\n  * Participants with positive HCV antibody and an undetectable HCV RNA are eligible to enroll.\n* Known human immunodeficiency virus (HIV) positive with an AIDS-defining opportunistic infection within the last year, or a current CD4 count \\\u003C 350 cells\u002FμL. Participants with HIV are eligible if they have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization and continue on ART as clinically indicated while enrolled on study. Viral serology only to be conducted if locally mandated and, if done, must be performed within 28 days of randomization.\n* Evidence of active infection that requires systemic antibacterial, antiviral, or antifungal therapy ≤ 7 days prior to the first dose of study intervention.\n* Live\u002Fattenuated vaccine received within 30 days of first treatment. The use of inactivated seasonal influenza vaccines (e.g., Fluzone®) will be permitted on study without restriction.\n* Any botanical preparation (e.g., herbal supplements or traditional Chinese medicines) intended to treat the disease under study within 4 weeks prior to treatment. The concurrent use of any botanical preparation is not permitted while on study.\n* Prior organ allograft.\n* History of allergy to study intervention or any of its components.\n* Known central nervous system (CNS) metastases or leptomeningeal disease is exclusionary unless adequately treated and the participant is no longer on steroids or anticonvulsants.\n* Participants unable to swallow oral medication or with gastrointestinal disorders that, per the treating physician's judgement, would likely to interfere with drug absorption, are excluded.\n* Pregnant or breastfeeding women are excluded.\n* History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, or multiple allergies.\n\nCohort 1 specific criteria:\n\n* Radiographically detectable metastatic disease and\u002For locally advanced PDAC.\n* Anticipated need for preoperative radiation therapy (as determined per the treating medical team: medical oncologist and\u002For surgical oncologist at the time of study enrollment)\n\nCohort 2 specific criteria:\n\n* Radiographically detectable metastatic disease.\n* Cytotoxic chemotherapy or targeted therapy within 28 days of Cycle 1 Day 1 is not permitted. Palliative radiotherapy must have been completed 14 or more days prior to Cycle 1 Day 1.\n* Participants with more than one prior line of therapy are excluded.\n* Clinically significant persistent toxicities (CTCAE v5.0 Grade ≥2) caused by previous cancer therapy, excluding alopecia and Grade 2 neuropathy, are not allowed.\n\nCohort 3 specific criteria:\n\n* Cytotoxic chemotherapy or targeted therapy within 28 days of Cycle 1 Day 1 is not permitted. Palliative radiotherapy must have been completed 14 or more days prior to Cycle 1 Day 1.\n* Participants with more than one prior line of therapy are excluded.\n* Clinically significant persistent toxicities (CTCAE v5.0 Grade ≥2) caused by previous cancer therapy, excluding alopecia and Grade 2 neuropathy, are not allowed",{"count":219,"type":20},60,[23],"To find out if the combination of BMS-986504 plus neoadjuvant\u002Fadjuvant chemotherapy and surgery (Cohort 1) or BMS-986504 plus standard of care chemotherapy (Cohorts 2 and 3) can help to control pancreatic cancer.",[223,224,225],"Phase 2 Study","BMS-986504","MTAP-deleted Pancreatic Cancer",{"date":28,"type":31},{"date":228,"type":31},"2026-04-09",{"date":230,"type":20},"2031-10-01",{"name":37,"class":38},{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":39},"100607378","phase-2-phase-ii-trial-of-single-agent-belzutifan-or-pembrolizumab-versus-combination-as-neoadjuvant-therapy-in-clear-cell-renal-cell-carcinoma-blaze-100607378","NCT07187778","Phase II Trial of Single Agent Belzutifan or Pembrolizumab Versus Combination as Neoadjuvant Therapy in Clear Cell Renal Cell Carcinoma (BLAZE)","Inclusion Criteria:\n\nPatient must meet the following criteria to be eligible for participation in the trial:\n\n* Biopsy or archival tissue proven clear cell renal cell carcinoma (ccRCC).\n\n  a. Extra tissue should be submitted if available for correlative analysis. Formalin-fixed paraffinembedded (FFPE) tissue blocks are preferred to slides. Details pertaining to tumor tissue submission can be found in the Lab Procedures Manual.\n* Has intermediate-high risk, high risk, or M1 ccRCC as defined by the following pathological tumor-node metastasis and tumor grading:\n\nIntermediate-high risk ccRCC\\*\n\n1. T2 (by radiographic\u002Fsize criteria), Grade 4 or with sarcomatoid\u002Frhabdoid features (on biopsy), N0, M0\n2. T3 (presence of tumor thrombus, perinephric and\u002For sinus fat invastion by imaging), any grade, N0, M0 High-risk ccRCC\\*\n3. T4, (by radiographic criteria), any grade, N0, M0\n4. T, any stage, any grade, N+, M0 M1 RCC participants who present with the primary kidney tumor, but also solid, isolated, soft tissue metastases that are planned to be completely resected at the time of nephrectomy are eligible (e.g. metastasis to ipsilateral adrenal gland).\n\n   * NOTE: Fuhrman Tumor Grade and\u002For WHO\u002FISUP Tumor Grade are required for all subjects entering the study.\n\n     • Evaluated by urology and approved as candidates for nephrectomy.\n\n     • Age ≥18 years and consent to participation.\n\n     • Performance status of 0-1 per Zubrod\u002FEastern Cooperative Oncology Group \\[ECOG\\] scale.\n\n     • Absence of distant metastases on imaging of chest, abdomen and pelvis within 42 days of enrollment (by CT, MRI, or PET imaging). Brain imaging is not required unless clinical suspicion per the treating provider.\n\n     • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\n     • Screening laboratory criteria include the following: a. ANC ≥1000, PLT ≥ 75, Hgb ≥9 (transfusion allowed if Hgb \\\u003C 1.5 or = to upper limit of normal\n\n     • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n\n     • Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (see below) prior to study entry and for the duration of study participation, including for 120 days after the last dose of pembrolizumab and 30 days after the last dose of belzutifan. WOCBP will be required to have a negative pregnancy test prior to cycle 1 day 1 of treatment, ≤24 hours prior to first dose of treatment. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n\n     • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 30 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n\n     • This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n     o Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n     * History of hysterectomy or bilateral salpingo-oophorectomy.\n     * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n     * History of bilateral tubal ligation or another surgical sterilization procedure.\n\n       • Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of study intervention:\n\n       • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR\n\n       • Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:\n\n       \\- Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant\n\n   Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n\n   \\- Male participants must also agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex.\n\n   • Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n   • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of pembrolizumab and 30 days after last belzutifan administration.\n   * Ability to understand and the willingness to sign a written informed consent document.\n\n   Exclusion Criteria:\n   * Has any of the following:\n\n\u003C!-- -->\n\n1. A pulse oximeter reading \\\u003C92% at rest, or\n2. Requires intermittent supplemental oxygen, or\n3. Requires chronic supplemental oxygen\n\n   • Patients who have had chemotherapy or radiotherapy for RCC prior to study.\n\n   • Patients who are receiving any other investigational agents.\n\n   • History of allergic reactions attributed to compounds of similar chemical or biologic composition to belzutifan, pembrolizumab, or other agents used in study.\n\n   • Prior systemic therapy with anti-PD1, PD-L1, PD-L2, or CTLA-4 or received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) ≤28 days prior to the first dose of study intervention.\n   * Diagnosis of immunodeficiency, active autoimmune disease (per Investigator's discretion), history of pneumonitis, active infection, or known additional malignancy other than RCC.\n   * Has a known history of HIV infection. Note: Testing for HIV at screening is only required if mandated by local health authority.\n   * Has a known history of HBV (defined as HBsAg reactive) or known active HCV (defined as HCV RNA \\[qualitative\\] is detected) infection.\n\nNote: Testing for HBV and HCV is only required if mandated by local health authority.\n\n• Patients who cannot fulfill study requirements for any reason.\n\n* Pregnant or breastfeeding women are excluded from this study because pembrolizumab is a Class-D agent with the potential for teratogenic or abortifacient effects and belzutifan has shown embryofetal toxicity in nonclinical studies\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n  a. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are NOT excluded. Invasive cancers are allowed if treated and in complete remission for at least 3 years.\n* Has any known metastatic disease that is not planned to undergo surgical resection at the time of surgery (with the exception of ipsilateral adrenal metastases that are resectable at surgery).\n* Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction ≤6 months from Day 1 of study drug administration, or New York Heart Association Class III or IV congestive heart failure. Medically controlled arrhythmia stable on medication is permitted.\n* Has moderate to severe hepatic impairment (Child-Pugh B or C).\n* Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).\n* Has received prior treatment with belzutifan or another HIF-2α inhibitor.\n* Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (eg, bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study.\n\nNote: A current list of strong\u002Fmoderate inducers of CYP3A4 can be found at the following website:\n\nhttps:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-druginteractionstable-substrates-inhibitors-and-inducers • Has an active infection requiring systemic therapy.\n\n• Has active TB.",{"count":159,"type":20},[23],"To learn if belzutifan alone, pembrolizumab alone, or belzutifan and pembrolizumab in combination given before a total or partial nephrectomy (surgery to remove all or part of a kidney) can help to control locally advanced ccRCC.",[242],"Clear Cell Renal Cell Carcinoma",{"date":28,"type":31},{"date":245,"type":31},"2025-12-19",{"date":247,"type":20},"2029-07-19",{"name":37,"class":38},{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":21,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":39},"100603512","phase-2-phase-ii-study-of-cd5-car-engineered-il15-transduced-cord-blood-derived-nk-cells-in-conjunction-with-lymphodepleting-chemotherapy-for-the-management-of-aggressive-t-cell-hematological-malignancies-100603512","NCT07137481","Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Aggressive T Cell Hematological Malignancies","Inclusion Criteria:\n\n1. 18-80 years of age\n2. Patients with hematological malignancies with an expression of CD5 in the tumor sample of ≥ 30% measured by immunohistochemistry or flow cytometry.\n3. Patients must meet disease-specific eligibility criteria.\n\n   a. Patients with a history of T-lymphoid malignancies, defined as T cell acute lymphoblastic leukemia\u002Flymphoma (T-ALL\u002FT-LBL), T-PLL, Peripheral T-cell lymphoma (PTCL-NOS), Hepatosplenic gamma\u002Fdelta NHL, AITL, Alk negative\u002F DUSP22 negative ALCL, or other subtypes of T cell NHL with indication for autologous or allogeneic transplant in CR-1 Patients with T-ALL and T-PLL who are in morphologic remission but flow MRD positive are eligible.\n4. Patients should be at least 1 week from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least three days prior to administration of lymphodepleting chemotherapy.\n5. Localized radiotherapy to one or more disease sites is allowed.\n6. Karnofsky Performance Scale \\> 50%.\n7. Adequate organ function:\n\n   1. Renal: Serum creatinine ≤ 2.0 ULN or estimated Glomerular Filtration Rate (eGFR using the CKI-EPI equation) ≥ 30 ml\u002Fmin\u002F1.73 m2.\n   2. Hepatic: ALT\u002FAST ≤ 3.0 x ULN or ≤ 5 x ULN if documented liver involvement with disease, Total bilirubin ≤ 2.0 ULN, except in subjects with Gilbert's Syndrome in whom total bilirubin must be ≤ 3.0 mg\u002FdL. No history of liver cirrhosis.\n   3. Cardiac: Cardiac ejection fraction ≥ 40%, no clinically significant pericardial effusion as determined by an ECHO or MUGA, and no uncontrolled arrhythmias or symptomatic cardiac disease.\n   4. Pulmonary: No clinically significant lung involvement, per PI discretion, pleural effusion, baseline oxygen saturation \\> 92% on room air.\n8. Ability to understand and the willingness to sign a written informed consent document.\n9. Weight ≥40 kg.\n10. English and non-English-speaking patients are eligible.\n11. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n    * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n    * History of hysterectomy or bilateral salpingo-oophorectomy.\n    * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n    * History of bilateral tubal ligation or another surgical sterilization procedure.\n\n    Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n    Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of study therapy.\n12. Signed consent to long-term follow-up protocol PA17-0483.\n\nExclusion Criteria:\n\n1. Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.\n2. Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI.\n3. Presence of uncontrolled fungal, bacterial, viral, or other infection not responding to appropriate therapy.\n4. Active hepatitis B or C.\n5. HIV with detectable viral load.\n6. Presence of active neurological disorder(s).\n7. Active autoimmune disease within 12 months of enrollment\n8. Active cerebral or meningeal involvement by the malignancy\n9. Active (defined as requiring therapy) acute or chronic GVHD.\n10. Any other malignancy known to be active, except for treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.\n11. Presence of any other serious medical condition that may endanger the patient at the investigator criteria.\n12. Major surgery \\\u003C4 weeks prior to first dose of study drug\n13. Allogeneic SCT or DLI \\\u003C12 weeks prior to first dose of study drug. Recipients of an allogeneic SCT patients should have discontinued all forms of immunosuppression at least 8 weeks prior to enrollment in the study.\n14. Concomitant use of other investigational agents.\n15. Concomitant use of other anti-cancer agents.\n16. Patients receiving systemic steroid therapy at the time of NK cell infusion (physiological substitutive doses are allowed) or have received ATG or lymphocyte immune globulin within 14 days or alemtuzumab within 3 months of enrollment.\n17. Patients receiving immunosuppressive therapy.\n18. Patients with diminished mental capacity will not be enrolled in the study.","80 Years",{"count":257,"type":20},70,[23],"To determine the safety and efficacy (1-year PFS) of iC9\u002FCD5CAR\u002FIL-15 NK cells as consolidation in patients with aggressive T-cell malignances in first remission.",[261],"Hematological Malignancies",{"date":28,"type":31},{"date":264,"type":20},"2027-02-28",{"date":266,"type":20},"2032-07-31",{"name":37,"class":38},{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":21,"phases":276,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":39},"100603200","phase-2-a-phase-2-platform-study-of-immunomodulatory-compounds-in-ici-refractory-non-small-cell-lung-cancer-100603200","NCT07133425","A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory Non-small Cell Lung Cancer","Eligibility Criteria\n\n1. Ability to understand and willingness to sign informed consent form (ICF) prior to initiation of the study and any study procedures.\n2. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of SAR445877 in participants \\\u003C18 years of age, children are excluded from this study.\n3. Participants with histologically documented locally advanced or metastatic NSCLC who have had disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment:\n4. Prior immune checkpoint inhibitor (anti-PD-(L)1) exposure. Participants need to have received at least 6 weeks of exposure to anti-PD-(L)1 and developed disease progression. Treatment with neoadjuvant or adjuvant ICI is acceptable if participant developed progression within one year of start of ICI therapy.\n5. One lesion suitable for repeat biopsy without significant risk to the participant.\n6. Measurable disease per RECIST v1.1.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 .\n8. Adequate organ and marrow function as defined below, obtained before study treatment initiation:\n\n   1. Hemoglobin \\>9.0 g\u002FdL\n   2. Absolute neutrophil count ≥1000\u002FmcL\n   3. Platelets ≥75,000\u002FmcL\n   4. Total bilirubin ≤1.5 institutional upper limit of normal (ULN). Documented Gilbert syndrome is allowed if total bilirubin is ≤3 × ULN.\n   5. AST\u002FALT ≤2.5 × institutional ULN. Transaminases up to 5 × ULN in the presence of liver metastases.\n   6. Measured or calculated creatinine clearance (CrCl; glomerular filtration rate can also be used in place of creatinine or CrCl) ≥30 mL\u002Fmin (CrCl should be calculated per institutional standard).\n   7. For participants not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time ≤1.5 × ULN. For participants receiving therapeutic anticoagulation: stable anticoagulant regimen.\n9. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result at screening.\n10. WOCBP must agree to use highly effective contraception for the duration of study participation and for 60 days after completion of study treatment. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a post-menopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this study must also agree to use adequate contraception for the duration of study participation and for 60 days after completion of study treatment. In addition, male participants must be willing to refrain from sperm donation during this time.\n11. Willing to undergo mandatory biopsies and blood collections as required by the study.\n12. Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and participant is clinically stable without requirement of steroid treatment for ≥ 7 days prior to the first dose of study treatment.\n13. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\nExclusion Criteria\n\n1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.\n2. Participants who are pregnant or breastfeeding.\n3. Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n4. Participants with a condition requiring systemic treatment with either corticosteroid (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study treatment initiation. Inhaled or topical steroids, and adrenal replacement steroid doses, are permitted in the absence of active autoimmune disease.\n5. History of interstitial lung disease (ILD) or checkpoint inhibitor-induced pneumonitis.\n6. Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome.\n7. Acute or chronic hepatitis B virus or hepatitis C virus infection. Prior viral exposure with cleared or fully treated infection based on negative HCV viral load is permitted.\n8. Previous solid organ or allogeneic hematopoietic stem cell transplant.\n9. Active infection requiring IV antibiotics or other uncontrolled intercurrent illness requiring hospitalization.\n10. Significant cardiovascular\u002Fcerebrovascular disease, including stroke, myocardial infarction, or prolonged QTc (\\> 480msec) within 3 months. Participants on beta blockers must be able to stop beta blockers for duration of their time on study treatment period when applicable.\n11. Participants who have not recovered from AEs due to prior anticancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia, hearing loss, grade 2 neuropathy or endocrinopathy managed with hormone replacement therapy.\n12. Participants who have previously been treated with PD-1, PD-L1, or CTLA-4 inhibitors and required permanent discontinuation or systemic immunosuppression (e.g. immune inhibitory monoclonal antibodies) due to irAEs.\n13. Participants who are receiving any other investigational agents.\n14. Treatment with a live, attenuated vaccine within 4 weeks prior to study treatment initiation, or anticipation of need for such a vaccine during the course of the study or within 5 months after the last dose of study treatment. Non-live COVID vaccines will be allowed on study, but it is recommended to avoid their use during the first treatment cycle (from 3 days prior to Cycle 1 Day 1 through Cycle 2 Day 3).\n15. Participants must have adequate washout from prior therapy at the time of study treatment initiation: 4 weeks from major surgery; 4 weeks from antibody-based therapy; 3 weeks from prior PD-(L)1 inhibitor exposure; 2 weeks or 5 half-lives (whichever is shorter) from any targeted therapy or small molecule therapy; 3 weeks or 5 half-lives (whichever is shorter) from chemotherapy or 6 weeks in the case of certain therapies (e.g., extensive radiotherapy, mitomycin C, and nitrosoureas); and 2 weeks from radiation therapy. Palliative radiotherapy is permitted for a preexisting lesion, provided it does not interfere with the assessment of tumor target lesions (e.g., the lesion to be irradiated must not be a site of measurable disease).\n16. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, ductal carcinoma in situ, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.\n17. Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.\n18. Inability to comply with the study and follow-up procedures.",{"count":275,"type":20},29,[23],"To learn if SAR445877 can help to control locally advanced or metastatic NSCLC in patients who have previously received ICI therapy.",[279,280],"Non-Small Cell Lung Cancer","ICI-refractory",{"date":28,"type":31},{"date":283,"type":31},"2025-11-06",{"date":285,"type":20},"2030-02-01",{"name":37,"class":38},{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":21,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":301,"leadSponsor":303,"locationsCount":39},"100600741","phase-1-phase-i-study-of-preconditioning-radiation-therapy-with-il-15-transduced-tgfbr2-ko-cartrop2-engineered-cord-blood-derived-nk-cells-in-patients-with-advanced-head-and-neck-cancer-radiance-nk-100600741","NCT07101432","Phase I Study of Preconditioning Radiation Therapy With IL-15 Transduced TGFBR2 KO CAR.TROP2-engineered Cord Blood-derived NK Cells in Patients With Advanced Head and Neck Cancer (RADIANCE-NK)","Inclusion Criteria:\n\nPatients with histologically confirmed head and neck cancer, either HPV+ or HPV-, that is locally advanced AND unresectable OR metastatic (≤5 sites of disease), which has relapsed or progressed following local standard treatments that are known to prolong survival, or for which no standard treatment is available or are no longer effective, or refused such therapy.\n\nPatient tumors must demonstrate TROP2 expression of 2+ or 3+ as determined by IHC at the MDACC CAP and CLIA accredited Clinical Laboratories.\n\n* 2 weeks from the last cytotoxic chemotherapy at the time of lymphodepleting chemotherapy; ≥3 days from last TKI or other targeted therapies at the time of lymphodepleting chemotherapy; ≥3 months from any cell therapy for any malignancy at the time of lymphodepleting chemotherapy; prior radiation therapy is allowed at the time of consent.\n\nRT allowed to ≥1 disease sites prior to the lymphodepleting chemotherapy. If there are additional measurable non-irradiated disease sites, this may be evaluated for response as well. If multiple lesions are irradiated, we advise that a single lesion will be treated to a higher dose and other lesions considered for lower doses, and that one site always remain unirradiated if a patient has ≥2 sites of disease.\n\nAge ≥18 years. Because no dosing or adverse event data are currently available on the use of TROP2 CAR\u002FIL-15 TGFBR2 KO NK cells in combination with radiation therapy in patients \\\u003C18 years of age, children are excluded from this study.\n\nPatients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nLife expectancy ≥3 months per PI or treating physician's discretion.\n\nA female patient is eligible to participate if at least one of the following conditions applies:\n\na. Not a woman of childbearing potential (WOCBP). OR\n\nA WOCBP who agrees to follow the contraceptive guidelines in Appendix 5 during the study treatment period and for 6 months post-TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell infusion.\n\nWOCBP must have a negative urine pregnancy test within 72 hours prior to the start of lymphodepleting chemotherapy. If a WOCBP has a urine pregnancy test that cannot be confirmed as negative, a serum (beta-human chorionic gonadotropin \\[B-hCG\\]) pregnancy test will be required.\n\nThe effects of TROP2 CAR\u002FIL-15 TGFBR2 KO NK cells on the developing human fetus are unknown. Radiation therapy is absolutely contraindicated in pregnant women. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n* Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n\nApproved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.\n\nA female patient who becomes pregnant, or suspects pregnancy while she or her partner is participating in this study, must immediately notify her doctor. Female patients who become pregnant will be taken off study.\n\nMale patients treated or enrolled on this protocol must agree to follow the contraceptive guidelines in Appendix 5 prior to study entry and for the duration of study participation and for 6 months post-TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell infusion. Male patients who father a child or suspect that they have fathered a child must immediately notify their doctor.\n\nPatients must have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n\nPatients must have adequate organ function as defined below within 10 days prior to the start of lymphodepleting chemotherapy:\n\nTable 1. Adequate Organ Function Laboratory Values\n\nSystemic Function Test Laboratory Value Hematologic ANC ≥ 1500\u002FµL Platelets ≥ 100,000\u002FµL Hemoglobin ≥9.0 g\u002FdLa Renal Creatinine ≤ 1.5 x ULNb OR CrCl by Cockcroft-Gault ≥30 mL\u002Fmin for patients with creatinine formula \\> 1.5 x ULNb Hepatic Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels \\>1.5 x ULN AST and ALT ≤2.5 x ULN (≤5 x ULN for patints with liver metastases) Coagulation PT\u002FINR ≤1.5 x ULN unless patien is receiving anticoagulant aPTT therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nALT=alanine aminotransferase; ANC=absolute neutrophil count; aPTT=activated partial thromboplastin time; AST=aspartate aminotransferase; CrCl=creatinine clearance; INR=international normalized ratio; PT=prothrombin time; ULN=upper limit of normal.\n\n1. Criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks of the screening test. Patients may be on a stable dose of erythropoietin (≥ approximately 3 months).\n2. Serum creatinine and CrCl should be interpreted and calculated per institutional standard.\n\n   Left ventricular ejection fraction \\>50%.\n\n   Adequate respiratory reserve defined as dyspnea Grade 0 or 1 and saturated oxygen \\>92% in room air. See Table 2 for a grading scale of dyspnea per the CTCAE v5.0.\n\n   Table 2. Dyspnea grading scale.\n\n   Grade 0 - No shortness of breath Grade 1 - Shortness of breath with moderate exertion Grade 2 - Shortness of breath with minimal exertion; limiting instrumental ADL Grade 3 - Shortness of breath at rest; limiting self-care ADL Grade 4 - Life threatening consequences; urgent intervention indicated Grade 5 - Death\n\n   Prior treatment with TROP2-targeted therapy will be allowed.\n\n   Willing to undergo mandatory blood collections and biopsies as required by the study.\n\n   Willing to sign consent for long-term follow-up on protocol PA17-0483.\n\n   Willing to stay within a 2-hour drive (approximately 100-mile radius) of the study site during the first 4 weeks after the TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell infusion.\n\n   Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\n   Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n\n   Ability to understand and the willingness to sign a written informed consent document.\n\n   Exclusion Criteria:\n   1. Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 6 months post TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell infusion.\n   2. Has received systemic anticancer therapy within 2 weeks or 5 half-lives, whichever is shorter, prior to the start of lymphodepleting chemotherapy. For patients treated with monoclonal antibodies, at least 3 weeks must have elapsed prior to the start of lymphodepleting chemotherapy. Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 3 weeks after the last dose of the previous investigational agent.\n   3. Patients must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Patients with ≤Grade 2 neuropathy, alopecia, or other non-relevant AEs may be deemed eligible at the discretion of the principal investigator (PI)\u002Fco-PIs. If a patient received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to the start of lymphodepleting chemotherapy.\n   4. If patients receive RT within 2 weeks of the start of lymphodepleting chemotherapy, they must not require corticosteroids, and not have had radiation pneumonitis.\n   5. Has received a live vaccine within 6 weeks prior to TROP2 CAR\u002FIL-15 TGFBR2 KO NK infusion and for at least 24 months post infusion. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza and COVID-19 vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n   6. Prior CAR T or NK cell or other genetically modified T or NK cell therapy.\n   7. Has diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent).\n   8. History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to patients who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in situ cancers.\n   9. Known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate if they completed radiation therapy, are clinically stable, and without requirement of steroid treatment for at least 2 weeks prior to study enrollment.\n   10. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.\n   11. History of interstitial lung disease (ILD) that required steroids or has current pneumonitis\u002FILD. 12. Active infection requiring systemic therapy.\n\n   13\\. Known human immunodeficiency virus (HIV) infection.\n\n   14\\. Known active or chronic hepatitis B or hepatitis C virus infection.\n\n   15\\. Known history of active tuberculosis (Mycobacterium tuberculosis).\n\n   16\\. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.\n\n   17\\. Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\n   18\\. Has had an allogenic tissue\u002Fsolid organ transplant.\n\n   19\\. Clinically significant cardiovascular disease within 12 months prior to the start of lymphodepleting chemotherapy, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebrovascular event, or cardiac arrhythmia associated with hemodynamic instability. NOTE: medically controlled arrhythmia would be permitted.\n\n   20\\. Prolongation of corrected QT interval using Fridericia's formula to \\>480 milliseconds.\n\n   21\\. Patients with bleeding or thrombotic disorders or at risk for severe hemorrhage. Patients with known deep vein thrombosis\u002Fpulmonary embolism who are on appropriate anti-coagulation treatment are eligible.\n\n   22\\. Patients with history of ≥Grade 3 stomatitis or mucositis with prior therapy.\n\n   23\\. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide and fludarabine or other agents used in study.",{"count":294,"type":20},33,[72],"To find the recommended dose of an investigational therapy called chimeric antigen receptor (CAR).TROP2\u002Finterleukin (IL)15-transduced TGFBR2 KO cord blood (CB)-derived natural killer (NK) cells (TROP2 CAR\u002FIL-15 TGFBR2 KO NK cells) that can be given with and without preconditioning radiation therapy in patients with advanced head and neck squamous cell carcinoma.",[298],"Head and Neck Cancer",{"date":28,"type":31},{"date":245,"type":31},{"date":302,"type":20},"2029-12-31",{"name":37,"class":38},{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":311,"minAge":17,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":21,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":39},"100598799","phase-2-phase-ii-decentralized-pragmatic-trial-of-adjuvant-doxorubicin---trabectedin-chemotherapy-in-ulms-100598799","NCT07076186","Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in uLMS","Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in Uterine Leiomyosarcoma","Inclusion Criteria:\n\n* Patients must have histologically confirmed uterine leiomyosarcoma\n* Patients must have localized tumors, AJCC stages 1b to 3 according to the AJCC uterine sarcoma staging system (high risk of relapse population)\n* Patients must have had complete surgical resection of tumor within 3 months prior to initiation of adjuvant chemotherapy, complete surgical resection includes at least a total hysterectomy\n* Patients must have no evidence of residual disease, as proven by CT Chest-Abdomen-Pelvic within 28 days before randomization (exclude potential metastatic patients)\n* Patients must have no history of pelvic radiation (hematologic tolerance of chemotherapy is impaired by pelvic radiation)\n* No prior chemotherapy for the treatment of the uterine leiomyosarcoma\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of doxorubicin in combination with trabectedin in patients \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status ≤2 (Karnofsky ≥60%,).\n* Patients must have adequate organ and marrow function as defined below:\n* absolute neutrophil count ≥1,000\u002FmcL\n* platelets ≥100,000\u002FmcL\n* total bilirubin ≤ institutional upper limit of normal (ULN) (except patients with Gilbert's syndrome, who must have total bilirubin \\\u003C 3.0 mg\u002FdL)\n* AST(SGOT)\u002FALT(SGPT) ≤2× institutional ULN\n* eGFR (using 2021 CKD-EPI) ≥40mL\u002Fmin\u002F1.73m2\n* Albumin \\> 28 g\u002FL\n* CPK ≤2× institutional ULN\n* No cardiac dysfunction as proven by LVEF\\>50%\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to doxorubicin or trabectedin or other agents used in study.\n* Patients with uncontrolled intercurrent illness per clinical judgment of the study PI and\u002For treating physician\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","FEMALE",{"count":313,"type":20},48,[23],"To find out if receiving standard chemotherapy (doxorubicin and trabectedin) can extend the cancer-free survival of patients with Stage 1b\u002F2 uterine leiomyosarcoma who had surgery that fully removed the tumor.",[317],"Uterine Leiomyosarcoma",{"date":28,"type":31},{"date":320,"type":31},"2025-10-02",{"date":322,"type":20},"2029-12-02",{"name":37,"class":38},{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":21,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":39},"100588370","phase-2-phase-ii-trial-of-ivonescimab-in-previously-treated-patients-with-advanced-clear-cell-renal-cell-carcinoma-100588370","NCT06940518","Phase II Trial of Ivonescimab in Previously Treated Patients With Advanced Clear Cell Renal Cell Carcinoma","Inclusion Criteria\n\n1. Participants with histologically or cytologically confirmed metastatic\u002Fadvanced clear cell RCC with a clear cell component who have received at least one prior line of systemic treatment in the advanced or metastatic setting, including a PD-1\u002FPD-L1 checkpoint inhibitor administered in metastatic\u002Fadvanced setting.\n\n   1. Participants in cohort 1 must have not received a treatment containing a VEGF- or HIF2a(- directed agent in prior treatment lines of treatment for metastatic\u002Fadvanced RCC\n   2. Participants in cohort 2 must have had progression on or after at least one prior line of treatment containing a VEGF-directed agent in prior lines of therapy\n2. Participants must have had evidence of disease progression on or after last treatment regimen received.\n3. Participants who received HIF-2ƒ¿ inhibitors in prior lines of therapy are eligible in cohort 2 but not cohort 1.\n4. Participants who received adjuvant immune checkpoint inhibitor are eligible, provided that they had progression while on adjuvant therapy, in which case they would be enrolled in cohort 1. Participants who recur after completing adjuvant therapy should receive a PD-1\u002FPD-L1 checkpoint inhibitor in the advanced\u002Fmetastatic setting to be eligible.\n5. Participants must have at least one measurable site of disease per RECIST version 1.1. This is defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). For non-lymph node tumor lesions, they must be a minimum size of ≥ 10 mm. For malignant lymph node lesions, they must be at least ≥ 15 mm in short axis with conventional techniques or ≥10 mm with more sensitive techniques such as MRI or spiral CT scan. If the participant has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.\n6. ECOG performance status ≤2\n7. Age ≥ 18 years\n8. Participants must have adequate organ and marrow function prior to study entry as defined below:\n9. INR and PT ≤ 1.5 x ULN and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5 ULN (unless abnormalities are unrelated to coagulopathy). Therapeutic anticoagulation is permitted if: on a stable dose of low molecular weight heparin (LMWH) for \\> 2 weeks (14 days) at the time of enrollment or on a direct oral anticoagulant (DOAC) for \\> 2 weeks at time of enrollment.\n10. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n11. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n12. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Patients who are Hepatitis C virus antibody positive (HCV Ab\n\n    +) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n13. Participants with a history of major psychiatric illness must be judged (by the treating physician) able to fully understand the investigational nature of the study and the risks associated with the therapy.\n14. The effects of Ivonescimab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy\n\n    \\# CLN1114). This includes all female participants , between the onset of menses (as early as 8years of age) and 55 years unless the participants presents with an applicable exclusionary factor which may be one of the following: i. Postmenopausal (no menses in greater than or equal to 12 consecutive months). ii. History of hysterectomy or bilateral salpingo-oophorectomy. iii. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). iv. History of bilateral tubal ligation or another surgical sterilization procedure.\n15. Female participants of childbearing potential (not postmenopausal for at least 12 months and not surgically sterile) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) before study entry. Pregnancy test must be repeated on the day of first infusion, if test performed \\> 14 days before starting study drug.\n16. Female participants of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the ivonescimab. Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of ivonescimab. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of ivonescimab.\n\n    1. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n       * Ability to understand and the willingness to sign a written informed consent document for this clinical trial and the companion Trials LAB02-152 and PA17-0577\n\nExclusion Criteria:\n\n1. Participants must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, or adequately treated (without recurrence post-resection or postradiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or low-risk early stage prostate adenocarcinoma with negligible risk of metastasis or death.\n2. Major surgical procedures or serious trauma within 4 weeks prior to enrollment, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to enrollment.\n3. Current hypertension with systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after adequate oral antihypertensive therapy.\n4. History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to enrollment, including but not limited to:\n\n   o Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots).\n\n   Transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n   * Nasal bleeding \u002Fepistaxis. Bloody nasal discharge is allowed.\n   * Hematuria associated with urinary obstruction. Microhematuria or macrohematuria not associated with urinary obstruction are allowed.\n   * Radiologically documented evidence of major blood vessel encasement with narrowing of the vessel that the investigator determines will pose a significantly increased risk of bleeding.\n5. History of major diseases prior to enrollment, specifically:\n\n   * Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification . grade 2) or vascular disease (eg, aortic aneurysm at risk of rupture) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n   * History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to enrollment.\n6. History of arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to enrollment.\n\n   * Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks prior to enrollment.\n   * History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to enrollment.\n7. Symptomatic CNS metastases, leptomeningeal disease, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to enrolmment, or potential need for CNS radiation within the first cycle of ivonescimab.\n\n   o Participants with treated\u002Fstable brain metastases are allowed on protocol if they had brain metastases that received CNS-directed therapy, such as surgery or treatment with radiosurgery or Gamma knife, without recurrence or edema for at least 1 month (4 weeks). Participants actively requiring glucocorticoids for uncontrolled brain or leptomeningeal metastases are not eligible. Participants must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone . 10 mg daily or equivalent).\n8. Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic inflammatory diarrhea).\n9. Participants who are receiving any other investigational agents.\n10. Active autoimmune disease requiring systemic therapy (e.g., with disease modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to enrollment. However the following will be allowed:\n\n    * Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n    * Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted.\n11. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n12. Severe infection within 4 weeks prior to enrollment, including but not limited to comorbidities requiring hospitalization, severe sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to enrollment (excluding antiviral therapy for hepatitis B or C).\n13. Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic. Participants managed with indwelling catheters (e.g., PleurX) are allowed.\n14. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ivonescimab or other agents used in study. This includes known history of severe hypersensitivity to other monoclonal antibodies.\n15. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n16. Participants with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for one month prior to enrollment. All patients with active hepatitis C (hepatitis C virus \\[HCV\\] antibody positive with HCV RNA levels above the lower limit of detection) are excluded.\n17. Pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5.0.\n18. Pregnant women are excluded from this study because ivonescimab is a bispecific agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ivonescimab, breastfeeding should be discontinued if the mother is treated with ivonescimab.\n\n    These potential risks may also apply to other agents used in this study.\n19. Participant is breastfeeding or plans to breastfeed during the study.\n20. Participants with persistent grade ≥ 2 adverse events per NCI CTCAE v5.0 from prior systemic therapies that would confound timely detection of immune-related adverse events due to ivonescimab or otherwise hinder patient participation in the clinical trial.\n21. History or current evidence of any condition (medical \\[including adverse events from prior anticancer therapy, disorders secondary to tumor\\], surgical or psychiatric \\[including substance abuse\\]), or laboratory abnormality that might confound the results of the study, interfere with the participants participation for the full duration of the study, might lead to higher medical risk and\u002For is not in the best interest of the patient to participate, in the opinion of the treating investigator",{"count":331,"type":20},40,[23],"To learn if ivonescimab can help to control previously treated, locally advanced or metastatic ccRCC.",[335,336],"Ivonescimab","Clear Cell Renal Carcinoma",{"date":28,"type":31},{"date":339,"type":31},"2025-07-02",{"date":341,"type":20},"2030-01-19",{"name":37,"class":38},{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":21,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":360},"100563474","phase-1-a-phase-ib-study-of-rezatapopt-in-combination-with-azacitidine-in-patients-with-tp53y220c-mutant-myeloid-malignancies-acute-myeloid-leukemia-or-myelodysplastic-syndrome-100563474","NCT06616636","A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome)","Inclusion Criteria:\n\n1. Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. Patient is willing and able to adhere to the study visit schedule and other protocol requirements.\n3. Patient has relapsed or primary refractory AML or MDS\n4. Any other comorbidity that per the investigator renders a patient inappropriate for intensive chemotherapy.\n5. Patients with MDS must be classified as MDS-IB1 or IB2 as per WHO 2022 criteria32\n6. TP53Y220C mutation confirmed by CLIA-approved local testing with a variant allele frequency \\>2%.\n7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2\n8. Patient has adequate organ function defined as:\n\n   * Serum aspartate aminotransferase\u002Fserum glutamic oxaloacetic transaminase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 3 x ULN, unless considered due to leukemic organ involvement.\n   * Serum total bilirubin ≤ 1.5 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert\\'s syndrome.\n   * Serum creatinine \\< 2 x ULN or creatinine clearance \\> 40 mL\u002Fmin based on validated glomerular filtration rate (GFR) estimation (Cockcroft-Gault, CKD-epi, or MDRD equations).\n9. Females of childbearing potential may participate provided they have a negative serum or urine pregnancy test at screening and a negative serum OR urine pregnancy test within 72 hours of starting on treatment. They also must agree to either abstain from sexual intercourse or use two forms of a highly effective method of contraception while on study and up to 3 months after the last dose of the study drug.\n10. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) 14 days prior to study entry and for the duration of study participation. This includes all female patients between the onset of menses and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n    Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n\n    History of bilateral tubal ligation or another surgical sterilization procedure.\n\n    • Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n    Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of investigational agent administration.\n11. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patient has received prior chemotherapy, targeted therapy, immunotherapy, or treatment with an investigational anticancer agent within 14 days or 5 half-lives (if half-life is known), whichever is shorter, before receiving their first dose of study drug.\n2. Patient has received radiotherapy within 14 days.\n3. Patients with acute promyelocytic leukemia\n4. Subject has immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and\u002For disseminated intravascular coagulation.\n5. Patients with active, uncontrolled leukemia involvement of the CNS\n6. Subject has known active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)\n7. Subject is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.\n8. Subject has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment).\n9. Patient has any unresolved toxicities from prior anti-cancer therapy greater than Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 prior chemotherapy induced neuropathy.\n10. Patient has had major surgery within 2 weeks prior to the planned start of study treatment.\n11. Female subject who is pregnant or lactating.\n12. History of allergic reactions attributed to compounds of similar chemical or biologic composition to azacitidine, rezetapopt or other agents used in study.",{"count":350,"type":20},24,[72],"A non-randomized phase Ib study of PC14586 (PMV therapeutics) in patients diagnosed with TP53Y220C-mutant myeloid malignancies, including AML and MDS.",[76,117],{"date":28,"type":31},{"date":356,"type":31},"2025-01-30",{"date":358,"type":20},"2029-08-27",{"name":37,"class":38},2,{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":367,"enrollmentInfo":368,"targetDuration":4,"studyType":21,"phases":370,"briefSummary":371,"conditions":372,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":39},"100542640","phase-2-high-dose-ruxolitinib-and-allogeneic-stem-cell-transplantation-in-myelofibrosis-patients-with-splenomegaly-100542640","NCT06345495","High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly","Inclusion Criteria:\n\n1. Participants 18 years to less than or equal to 75 years.\n2. Able to provide written consent.\n3. Primary or secondary Myelofibrosis (may have received Jak inhibitors including ruxolitinib)\n4. Enlarged spleen by palpation or imaging. For the purpose of this study, splenomegaly is defined as any clinically palpable spleen or spleen larger than 12 cms on imaging.\n5. Has a fully matched (8\u002F8:HLA A, B, C, DRB1) related or matched unrelated donor.\n6. Adequate renal function, including:\n\n   a. Serum creatinine \\\u003C\u002F= 1.5 mg\u002FdL or estimated Glomerular Filtration Rate (eGFR using the CKI-EPI equation) \\>\u002F= 40 ml\u002Fmin\u002F1.73 m2.\n7. Adequate liver function, including:\n\n   1. ALT\u002FAST \\\u003C\u002F= 3 x ULN\n   2. Direct bilirubin \\\u003C\u002F= 1mg\u002FdL\n   3. No history of liver cirrhosis. No ascites.\n8. Female participants of childbearing potential must have negative results for a serum pregnancy test. Female participants must agree to not breastfeed during the study and for 3 months post-completion of the study therapy.\n9. Subjects who are of childbearing potential, sexually active, and at risk of pregnancy must agree to use a highly effective method of contraception for the duration of the active treatment and at least 3 months post-completion of the study therapy. Highly effective methods of contraception include the following:\n\n   1. Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n   2. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study agent administration. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.\n\nExclusion Criteria:\n\n1. Positive beta HCG in females of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.\n2. Ejection fraction \\\u003C40%\n3. Corrected DLCO \\\u003C 50%\n4. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n   1. Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal)\n   2. Active hepatitis B virus (HBV), hepatitis C (HCV), HIV or TB infection or requiring treatment for the same.\n   3. Thrombosis including MI, Stroke, PE, DVT in the past 6 months\n\nNote: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate.","75 Years",{"count":369,"type":20},30,[23],"To learn if giving ruxolitinib and busulfan before a stem cell transplant can help to reduce spleen size and help the transplant to succeed.",[373,374],"Splenomegaly","Myelofibrosis",{"date":28,"type":31},{"date":377,"type":31},"2024-10-01",{"date":379,"type":20},"2029-01-01",{"name":37,"class":38},{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":255,"enrollmentInfo":388,"targetDuration":4,"studyType":21,"phases":390,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":39},"100521189","phase-1-ph-iii-trial-of-cord-blood-derived-nk-cells-with-ny-eso-1-tcril-15-for-rr-myeloma-100521189","NCT06066359","Ph I\u002FII Trial of Cord Blood-derived NK Cells With NY-ESO-1 TCR\u002FIL-15 for R\u002FR Myeloma","Phase I\u002FII Trial of Cord Blood-Derived NK Cells Genetically Engineered With NY-ESO-1 TCR\u002FIL-15 Cell Receptor for Relapsed\u002FRefractory Multiple Myeloma","Inclusion criteria:\n\n1\\. Patients with multiple myeloma with an expression of NY-ESO-1 by immunohistochemistry in the pre-screening or screening tumor sample or PCR NY-ESO-1 testing by Pathology. CD138 by immunostains will be performed to identify plasma cells before testing for NY-ESO-1 2. Patients are HLA-A\\*02:01, HLA-A\\*2:05, or HLA-A\\*2:06 positive on human leukocyte antigen (HLA) typing at any time.\n\n3\\. Patients with relapsed or refractory multiple myeloma (MM) (patients with solitary plasmacytoma are not eligible) who meet the following criteria:\n\n1. \\> or = 2 prior lines of therapy (including exposure to at least one proteasome inhibitor, immunomodulatory imide drug \\[ImiD\\], and anti-cd38 antibody and refractory to the last line of therapy)\n2. Have measurable disease (serum monoclonal \\[M\\] protein level ≥ 0.5 g\u002FdL, and\u002For urine M protein level ≥ 200 mg\u002F24hrs, and\u002For involved serum free light chain \\[FLC\\] level ≥10 mg\u002FdL provided the serum-free light-chain ratio is abnormal) \\*\\* Refractory is defined as a documented progressive disease during or within 60 days (measured from the last dose of any drug within the regimen) of completing treatment with the last anti-myeloma regimen before study entry 4. No anti-myeloma therapy within 7 days of lymphodepleting therapy. Note: Steroids are allowed at any time up until lymphodepletion. Localized radiation for palliation is allowed at any time up until NK cell infusion 5. Prior autologous\u002Fallogeneic transplants are allowed. 6. Prior cell therapy is allowed against targets other than NY-ESO-1. 7. Patients must have recovered from systemic toxicity of prior anti-myeloma therapy at the start of lymphodepletion 8. Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C= 2 9. Estimated glomerular filtration rate (eGFR using the Chronic Kidney Disease Epidemiology Collaboration \\[CKI-EPI\\] equation) \\>= 30 ml\u002Fmin\u002F1.73 m\\^2 10. Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) =\\\u003C 2.5 x upper limit of normal (ULN) or =\\\u003C 5 x ULN if documented liver metastases 11. Total bilirubin =\\\u003C 1.5 mg\u002FdL, except in subjects with Gilbert's syndrome in whom total bilirubin must be =\\\u003C 3.0 mg\u002FdL 12. No history of liver cirrhosis 13. No ascites 14. Cardiac ejection fraction \\>= 50% 15. No clinically significant pericardial effusion as determined by an ECHO or MUGA 16. No uncontrolled arrhythmias or symptomatic cardiac disease 17. No clinically significant pleural effusion (per principal investigator \\[PI\\] discretion) 18. Baseline oxygen saturation \\> 92% on room air 19. Able to provide written informed consent 20. 18-80 years of age 21. Weight ≥ 40 kg 22. Absolute neutrophil count (ANC) ≥ 1000 \u002F\n\n   * Note: Growth factor support is allowed prior to lymphodepletion chemotherapy (LD chemo). Transfusion support is allowed at any time. If cytopenias are related to multiple myeloma, the patient may proceed without meeting above hematologic parameters only if bone marrow plasma cells are \\>= 50% 19. Hemoglobin ≥ 8 g\u002FdL\n   * Note: Growth factor support is allowed prior to LD chemo. Transfusion support is allowed at any time. If cytopenias are related to multiple myeloma, the patient may proceed without meeting above hematologic parameters only if bone marrow plasma cells are \\>= 50% 20. Platelet count \\>= 25,000 \u002FuL\n   * Note: Growth factor support is allowed prior to LD chemo. Transfusion support is allowed at any time. If cytopenias are related to multiple myeloma, the patient may proceed without meeting above hematologic parameters only if bone marrow plasma cells are \\>= 50% 21. All participants who are able to have children must practice effective birth control while on study and up to 3 months post completion of study therapy. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. The study team will ask for information about the pregnancy 22. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor 23. Signed consent to long-term follow-up protocol PA17-0483 to fulfill the institutional responsibilities to various regulatory agencies 24. Patients with relapsed or refractory plasma cell leukemia who have received at least two previous regimens\n\nCRITERIA FOR LYMPHODEPLETION:\n\nPatient should continue to meet eligibility criteria above with the following exceptions:\n\n\\* Platelet count \\>\u002F= 25,000 \u002FμL\n\n\\*\\* Note: Growth factor support is allowed prior to LD chemo. Transfusion support is allowed at any time. If cytopenias are related to multiple myeloma, the patient may proceed without meeting above hematologic parameters only if bone marrow plasma cells are \\>= 50%\n\nCRITERIA FOR CELL INFUSION:\n\nPatients who meet one of the following criteria on the day of infusion will have their administration delayed for 24 hours. If these problems persist beyond 24 hours, patients will not receive their cell infusion.\n\n1. Cardiac arrhythmias not controlled with medical management\n2. Hypotension requiring vasopressor support\n3. Suspected or active uncontrolled infection\n\nExclusion Criteria\n\n1. Active or uncontrolled infection at the start of lymphodepletion and\u002For cell infusion\n2. Patients with concurrent autoimmune diseases with neurologic involvement, such as multiple sclerosis\n3. Participants who have received any live vaccines within 30 days prior to study entry\n4. Any active infection requiring systematic antibiotics\n5. Any evidence of another malignancy within the last 2 years prior to screening that has not been treated with curative intent (except in situ non-melanoma skin cell cancers and\u002For carcinoma in-situ of the cervix or other conditions that are deemed low-risk after discussion with the medical monitor)\n6. Any major surgery within 28 days of lymphodepletion, minor surgery within 14 days of lymphodepletion, or any planned medical or surgical procedure that in the opinion of the investigator, might jeopardize the patient's safety",{"count":389,"type":20},44,[72,23],"To find the recommended dose of NY-ESO-1 TCR\u002FIL-15 NK cells that can be given to patients with relapsed or refractory MM.\n\nTo learn if the dose of NY-ESO-1 TCR\u002FIL-15 NK cells found in Part A can help to control the disease.",[393],"Relapsed\u002FRefractory Myeloma",{"date":28,"type":31},{"date":396,"type":31},"2023-11-30",{"date":398,"type":20},"2028-08-31",{"name":37,"class":38},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":21,"phases":407,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":411,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":39},"100519568","phase-2-phase-2-trial-of-epcoritamab-in-combination-with-rituximab-mini-cvp-for-older-unfitfrail-patients-or-anthracycline-ineligible-adult-patients-with-newly-diagnosed-diffuse-large-b-cell-lymphoma-100519568","NCT06045247","Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit\u002FFrail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\nPatients must meet the following criteria for study entry:\n\n* Age ≥18 years\n* Histologically diagnosed\n* Diffuse large B-cell lymphoma, not otherwise specified (NOS) or\n* High grade B-cell lymphoma (NOS or MYC and BCL2 rearrangements) or\n* T cell\u002Fhistiocyte-rich large B-cell lymphoma\n* Have no prior systemic treatment for current lymphoma\n* Ineligible for anthracycline-based cytotoxic chemotherapy due to one or more of the following:\n* Age ≥80\n* Unfit\u002Ffrail by simplified geriatric assessment4\n* The link to calculate simplified geriatric assessment https:\u002F\u002Fredcap.filinf.it\u002Fsurveys\u002F?s=89AFXML8AK Criteria Fit Unfit Frail ADL ≥ 5 \\\u003C 5 6 \\\u003C 6 IADL ≥ 6 \\\u003C 6 8 \\\u003C 8 CIRS-G 0 score = 3-4\n\n  ≤ 8 score = 2 ≥ 1 score = 3-4 8 score = 2 0 score = 3-4 \\\u003C 5 score = 2 ≥ 1 score = 3-4\n\n  ≥ 5 score = 2 Age \\\u003C80 \\\u003C 80 ≥ 80 ≥ 80 Abbreviations: ADL, activities of daily living; IADL, instrumental ADL; CIRS-G, Cumulative Illness Rating Scale for Geriatrics\n* Ejection fraction (EF) \\\u003C50% but ≥30%\n* Needs to be asymptomatic or minimally symptomatic, New York Heart Association (NYHA) class 1 or 2\n* Previous cardiotoxic cancer treatment with anthracycline\n* Stage II bulky (\\>7cm), III or IV disease\n* Performance status ≤2 on the ECOG scale (PS ≤3 if attributed to lymphoma and improves to ≤2 by pre-phase treatment prior to enrollment)\n* Bi-dimensionally measurable disease, with at least one nodal lesion ≥ 1.5 cm or one extra-nodal lesion \\> 1 cm in longest diameter by CT, PET\u002FCT, and\u002For MRI\n* Patients must have adequate organ and marrow function as defined below:\n* Absolute neutrophil count (ANC) ≥1.0 × 109\u002FL\\*\n\n  --\\*Growth factor permitted during screening\n* Platelet count ≥75 × 109\u002FL\n* Total bilirubin ≤ 3 ULN, unless consistent with Gilbert's (ratio between total and direct bilirubin \\> 5)\n* AST and ALT ≤ 3x upper limit of normal (ULN)\n* Alkaline phosphatase \\\u003C 2.5 ULN\n* Creatinine clearance \\>45 ml\u002Fmin calculated by modified Cockcroft-Gault formula\n* All subjects must\n* Agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 12 months following the last dose of study treatment.\n* Sign an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.\n\nThe investigator is responsible for: ensuring that the patient understands the potential risks and benefits of participating in the study; ensuring that informed consent is given by each patient, this includes obtaining the appropriate signatures and dates on the informed consent document prior to the performance of any study procedures and prior to the administration of study treatment; answering any questions the patient may have throughout the study and sharing in a timely manner any new information that may be relevant to the patient's willingness to continue his or her participant in the trial. Subjects will undergo a brief physical exam including a brief exam to determine cognitive review. No one without capacity to personally consent will be enrolled. Patients have medical decision-making capacity if they can demonstrate understanding of the situation, appreciation of the consequences of their decision, and reasoning in their thought process, and if they can communicate their wishes.\n\nA determination of lack of decision-making capacity shall be made after an appropriate medical evaluation that concludes there is little or no likelihood that the participant will regain decision-making capacity in a reasonable period of time.\n\n* Females must agree to abstain from breastfeeding during study participation and for at least 12 months after epcoritamab discontinuation.\n* Females of childbearing potential (FCBP§) must:\n* Have one negative pregnancy tests via serum or urine prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, prior to day 1 of each cycle, and after end of study therapy. This applies even if the subject practices true abstinence\\* from heterosexual contact.\n* Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice. Otherwise, she must agree to use, and be able to comply with two forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting epcoritamab, during the study treatment (including dose interruptions), and for at least 12 months after the last dose of epcoritamab.\n* Male subjects must:\n* A male subject who is sexually active with a female with reproductive potential must agree to use a barrier method of birth control, eg, either condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository or partner with occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002F suppository (including dose interruptions), even if they have undergone a successful vasectomy, from the time of signing consent and for at least 12 months after the last dose of epcoritamab. A male subject must agree not to donate sperm or semen, while taking epcoritamab, during breaks (dose interruptions), and for at least 12 months after the last dose of epcoritamab.\n\nExclusion Criteria\n\nSubjects will be ineligible for this study if they meet any of following criteria:\n\n* Known central nervous system lymphoma or leptomeningeal disease\n* Suspicious case with symptoms should be evaluated with brain MRI with or without Any prior history of other malignancy besides B-NHL, unless the patient has been free of disease for ≥ 3 years and felt to be at low risk for recurrence by the treating physician, except:\n* Adequately treated localized skin cancer without evidence of disease.\n* Adequately treated cervical carcinoma in situ without evidence of disease.\n* Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study outcomes at undue risk.\n* Uncontrolled human immunodeficiency virus (HIV), or active Hepatitis C Virus, or active Hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed JC virus infection and SARS-CoV2\n* Patients with inactive hepatitis B infection must adhere to hepatitis B reactivation prophylaxis unless contraindicated. Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded. Subjects with a history of Hepatitis C who received antiviral treatment are eligible as long as PCR is negative.\n* History of severe allergic or anaphylactic reactions or intolerance to anti-CD20 monoclonal antibody therapy or any bispecific antibody.\n* History of immunodeficiency (with the exception of hypogammaglobulinemia) or concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of \\>10mg\u002Fday of prednisone) within 28 days of the first dose of study drug with exception of steroid used for IV contrast allergy. In addition, use of inhaled, topical, intranasal corticosteroids or local steroid injection (eg, intra- articular injection) is permitted.\n* Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification. Subjects with controlled, asymptomatic heart failure during screening can enroll on study.\n* Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree atrioventricular (AV) block, type II AV block, 3rd degree block, 12-lead ECG showing a baseline QTcF \\>470 msec.\n* History of stroke, seizure disorder or patients requiring antiepileptic therapy or intracranial hemorrhage within 6 months prior to study entry.\n* Patients with more than mild pericardial effusion confirmed by ECHO.\n* Lactating or pregnant subjects\n* Administration of any investigational agent within 28 days of first dose of study drug.\n* Patients who have undergone major surgery within 28 days or minor surgery within 3 days of first dose of study drug.\n* Patients taking chronic corticosteroids for other diseases, unless administered at a dose equivalent to \\\u003C 10 mg\u002Fday prednisone. For corticosteroids, prednisolone \\>20 mg daily (or equivalent) qualifies as immunosuppressive and thus is excluded for this use. Note: corticosteroids at any dose are permitted for control of lymphoma-related symptoms, including during screening, and for prophylaxis or AE management during the trial.\n* Life expectancy \\\u003C 6 months\n* Neuropathy \\> Grade 1\n* Prior exposure to epcoritamab, independently from indication\n* Patients who have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Patients who have a history of (non-infectious) pneumonitis that require steroids or has current pneumonitis.",{"count":331,"type":20},[23],"To learn if adding epcoritamab to the treatment combination R-miniCVP (rituximab, cyclophosphamide, vincristine, prednisone) can help to control newly diagnosed DLBCL. The safety of this combination will also be studied.",[410],"Large B-cell Lymphoma",{"date":28,"type":31},{"date":413,"type":31},"2024-01-05",{"date":415,"type":20},"2030-07-31",{"name":37,"class":38},{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":311,"minAge":17,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":21,"phases":425,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":39},"100488130","phase-1-phase-1b-of-lurbinectedin-in-combination-with-weekly-paclitaxel-and-bevacizumab-in-platinum-resistant-ovarian-cancer-100488130","NCT05636111","Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer","Inclusion Criteria:\n\nInclusion criteria will be assessed within 28 days of starting study treatment:\n\n1. Ability to provide signed informed consent in accordance with federal, local, and institutional guidelines.\n2. Age ≥ 18 years at time of study entry\n3. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n4. Histologically confirmed and documented ovarian, fallopian tube or peritoneal carcinoma: Patients with platinum refractory\\* or platinum resistant\\*\\* disease are allowed. Prior anti-VEGF targeted therapy (e.g. bevacizumab, VEGF TKI's) is allowed.\n\n   * Platinum refractory is defined as progression during platinum-containing therapy or within 4 weeks of last dose.\n   * Platinum resistant is defined as relapse-free interval 1-6 months of a platinum-containing therapy\n5. Prior Therapy: Unlimited prior systemic therapies are allowed.\n6. ECOG performance status of 0-1 (Appendix A)\n7. Adequate normal organ and marrow function as defined below.\n\n   1. Hemoglobin ≥9.0 g\u002FdL.\n   2. Absolute neutrophil count (ANC) \\> 1500\u002Fmm3.\n   3. Platelet count ≥100 x 109\u002FL\n   4. Serum bilirubin ≤1.5 x ULN. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\n   5. AST (SGOT)\u002FALT (SGPT) ≤2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN.\n   6. Measured creatinine clearance (CL) \\>40 mL\u002Fmin or Calculated creatinine CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:\n\n   Creatinine CL (mL\u002Fmin) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg\u002FdL)\n8. Evidence of post-menopausal status or negative urine or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n   1. Women \\\u003C50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n   2. Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose.\n   3. Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n9. Measurable disease by RECIST v1.1\n\nExclusion Criteria:\n\nExclusion criteria will be assessed within 28 days of starting study treatment. Patients meeting any of the following exclusion criteria are not eligible to enroll in this study.\n\n1. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤2 weeks prior to cycle 1 day 1.\n2. Use of an anti-cancer treatment drug or investigational drug during the last 28 days or 5 half-lives (whichever is shorter) prior to cycle 1 day 1. A minimum of 10 days between termination of prior treatment and administration of study treatment is required.\n3. Patients with known or suspected conditions likely to increase gastrointestinal toxicity, such as inflammatory bowel disease, bowel obstruction, history of bowel obstruction, or overt bowel involvement by tumor.\n4. Patients who are pregnant or lactating.\n5. Major surgery \\\u003C\u002F= 28 days prior to cycle 1 day 1.\n6. Unstable cardiovascular function:\n\n   1. ECG abnormalities requiring treatment, or\n   2. congestive heart failure (CHF) of NYHA Class ≥3, or\n   3. myocardial infarction (MI) within 3 months.\n7. Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study.\n8. Any known history or evidence of hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen); Known to be HIV seropositive\n9. Grade \\>2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1).\n10. Serious psychiatric or medical conditions that could interfere with treatment;\n11. Participation in an investigational anti-cancer study within 3 weeks prior to Cycle 1 Day 1\n12. Concurrent therapy with approved or investigational anticancer therapeutic other than steroids.\n13. Patients with coagulation problems and active bleeding within 4 weeks prior to C1D1 (peptic ulcer, epistaxis, spontaneous bleeding)\n14. Patients with symptomatic brain lesions\n15. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).\n16. History of hemoptysis (1\u002F2 teaspoon of bright red blood per episode) within 1 month of study enrollment for any tumor type.\n17. Non-healing wound, ulcer or bone fracture.\n18. Known hypersensitivity to lurbinectedin, paclitaxel, bevacizumab or excipients.",{"count":424,"type":20},34,[72],"To learn if adding lurbinectedin to the combination of paclitaxel and bevacizumab can help to control advanced cancer.",[428],"Ovarian Cancer",{"date":28,"type":31},{"date":431,"type":31},"2023-07-12",{"date":433,"type":20},"2026-12-31",{"name":37,"class":38},{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":442,"sex":16,"minAge":443,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":21,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":39},"100466931","phase-1-a-phase-i-ii-study-investigating-the-all-oral-combination-of-the-menin-inhibitor-sndx-5613-with-decitabinecedazuridine-astx727-and-venetoclax-in-acute-myeloid-leukemia-save-100466931","NCT05360160","A Phase I-II Study Investigating the All-Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine\u002FCedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)","A Phase I-II Study Investigating the All Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine\u002FCedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)","Inclusion Criteria:\n\n1. Age ≥ 12 years with weight ≥ 40Kg.\n2. ECOG performance status of ≤ 2.\n3. Newly diagnosed (frontline cohort), who are not eligible for high-intensity induction chemotherapy or relapsed\u002Frefractory (R\u002FR cohort) AML or myeloid phenotype MPAL with either KMT2Ar, or NUP98r, or NPM1c.\n4. WBC must be below 25,000\u002F μL at time of enrollment. Patients may receive cytoreduction prior to enrollment.\n5. Baseline ejection fraction must be \\> 40%.\n6. Adequate hepatic function (direct bilirubin \\\u003C 2x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and\u002For ALT \\\u003C 3x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and\u002For ALT \\\u003C 5x ULN will be considered eligible).\n7. Adequate renal function (creatinine clearance ≥ 30 mL\u002Fmin) unless related to disease.\n8. Willing and able to provide informed consent.\n9. In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 14 days for cytotoxic or non-cytotoxic (immunotherapy agent(s), or an interval of 5 half-lives of the prior therapy. Oral hydroxyurea and\u002For cytarabine (up to 2 g\u002Fm2) for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the PI. Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted.\n10. Women of childbearing potential must agree to adequate methods of contraception during the study and at least 3 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study and at least 3 months after the last treatment.\n\nExclusion Criteria:\n\n1. Prior treatment with a menin inhibitor.\n2. Patients with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.\n3. The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea for patients with rapidly proliferative disease or for control of counts during differentiation syndrome. (3) use of steroids for treatment of differentiation syndrome.\n4. Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.\n5. Patients with a concurrent active malignancy under treatment.\n6. Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.\n7. Female subjects who are pregnant or breast-feeding.\n8. Patient has an active uncontrolled infection.\n9. Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled\u002Funstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.\n10. QTc \\>470 msec using the Fridericia Formula.\n11. History of a complete bundle branch block or high-degree atrioventricular block.\n12. History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.\n13. Clinically active central nervous system (CNS) leukemia.\n14. Patients on immunosuppressive therapy post-HSCT at the time of screening with R\u002FR leukemia (must be off all systemic immunosuppression therapy for at least 2 weeks and calcineurin inhibitors for at least 4 weeks). The use of topical steroids for cutaneous graftversus- host disease (GVHD) or stable systemic steroid doses less than or equal to 20 mg of prednisone daily are permitted.\n15. Patients with Grade \\> 2 active acute GVHD, moderate or severe limited chronic GVHD, or extensive chronic GVHD of any severity.",true,"12 Years",{"count":445,"type":20},43,[72,23],"Part 1b of this clinical research study is to find the highest tolerable dose of SNDX-5613 that can be given in combination with ASTX727 (a combination of the drugs decitabine\u002Fcedazuridine) and venetoclax for patients with acute myeloid leukemia (AML) or those with a mixed phenotype acute leukemia with a myeloid phenotype (MPAL).\n\nPart 2 of this study is to learn if the dose of study drugs found in Part 1b can help to control AML\u002FMPAL",[117],{"date":28,"type":31},{"date":451,"type":31},"2022-10-14",{"date":453,"type":20},"2026-12-01",{"name":37,"class":38},{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":21,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":471,"locationsCount":39},"100465062","phase-1-first-in-human-assessment-of-safety-biodistribution-and-pharmacokinetics-of-18f-fluoro-1-naphthol-18f-4fn-for-pet-imaging-100465062","NCT05335811","First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol (18F-4FN) for PET Imaging","Inclusion Criteria:\n\n* Patient \\>\u002F= 18 years of age.\n* Patients with histologic diagnosis of solid or liquid tumor treated by ICI with evidence of or clinical suspicion of irAE or patients with suspected inflammation.\n* Normal range standard renal and liver function tests for age:\n\neGFR \\>= 60 mL\u002Fmin\u002F1.73 m2\n\nAdequate liver function:\n\nBilirubin ≤ the upper limit of normal (ULN) Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ the ULN\n\nExclusion Criteria:\n\n* Pregnant or lactating women: pregnant women are excluded from this study because the effects of \\[18F\\]4FN in pregnancy are not known. Urine or serum pregnancy test (female \\\u003C\u002F= 60 years of age or childbearing potential) within 24 hours of the PET scan.\n* Subjects with contraindications to the use of \\[18F\\]4FN including confirmed allergy.\n* Patients with a body weight of 400 pounds or more, or a BMI which precludes their entry into the bore of the PET\u002FCT scanner, because the hardware is not intended to support that weight.\n* Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the physician may significantly interfere with study compliance.\n* Children below the age of 18 are excluded because of the unknown but potential risk of administration of radiopharmaceuticals to minors.",{"count":462,"type":20},55,[72],"18F-4FN represents a novel PET agent for imaging inflammation. Acute inflammatory signaling through the TLR axis recruits neutrophils and macrophages to inflammatory sites. Both cells activate the production of high energy reactive oxygen species\u002Freactive nitrogen species (RONS), setting off a cascade that can be leveraged to detect the presence of these inflammatory cells by molecular imaging. 18F-4FN is efficiently oxidized by high energy RONS, leading to retention and accumulation in human neutrophil-like cells in vitro, and at the sites of acute inflammation in vivo. Like 18F-FDG, 18F-4FN clears rapidly through the kidney at 1 hr following i.v. injection",[466],"Endocrine Neoplasia",{"date":28,"type":31},{"date":469,"type":31},"2022-10-06",{"date":398,"type":20},{"name":37,"class":38},{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":21,"phases":480,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":39},"100447769","phase-1-phase-iii-study-of-cd5-car-engineered-il15-transduced-cord-blood-derived-nk-cells-in-conjunction-with-lymphodepleting-chemotherapy-for-the-management-of-relapsedrefractory-hematological-malignances-100447769","NCT05110742","Phase I\u002FII Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed\u002FRefractory Hematological Malignances","Inclusion criteria\n\n1. Patients with hematological malignances with an expression of CD5 in the pre-enrollment tumor sample ≥ 30% measured by immunohistochemistry or flow cytometry.\n2. Patients must meet diseases specific eligibility criteria (see below)\n3. Patients should be at least 1 week from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy, with the last day of cytotoxic chemotherapy no later than Day-13. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least three days prior to administration of lymphodepleting chemotherapy, with the last day of tyrosine kinase inhibitors or other targeted therapies no later than Day-9.\n4. Localized radiotherapy to one or more disease sites are allowed prior the infusion provided that there are additional disease sites that are not irradiated.\n5. Karnofsky\u002FLansky Performance Scale \\> 50%.\n6. Adequate organ function:\n\n   1. Renal: Serum creatinine ≤ 2.0ULN or estimated Glomerular Filtration Rate (eGFR using the CKI-EPI equation) ≥ 30 ml\u002Fmin\u002F1.73 m2.\n   2. Hepatic: ALT\u002FAST ≤ 3.0 x ULN or ≤ 5 x ULN if documented liver involvement with disease, Total bilirubin ≤ 2.0ULN, except in subjects with Gilbert's Syndrome in whom total bilirubin must be ≤ 3.0 mg\u002FdL. No history of liver cirrhosis.\n   3. Cardiac: Cardiac ejection fraction ≥ 40%, no clinically significant pericardial effusion as determined by an ECHO or MUGA, and no uncontrolled arrhythmias or symptomatic cardiac disease.\n   4. Pulmonary: No clinically significant lung involvement, per PI discretion, pleural effusion, baseline oxygen saturation \\> 92% on room air.\n7. Able to provide written informed consent.\n8. 12-80 years of age.\n9. English and non-English speaking patients are eligible.\n10. All participants who are able to have children must practice effective birth control while on study and up to 3 months post completion of study therapy. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.\n11. Signed consent to long-term follow-up protocol PA17-0483.\n12. Are willing and able to provide informed consent.\n13. Disease specific inclusion criteria\n\nA. T-cell non-Hodgkin's lymphoma and T-cell acute lymphoblastic leukemia\n\n1. Patients with history of T-lymphoid malignancies, defined as acute lymphoblastic leukemia (ALL\u002FT-LBL), Peripheral T-cell lymphoma (PTCL-NOS), MF\u002FSS, Hepatosplenic gamma\u002Fdelta NHL, AITL, ALCL, or other subtypes of T cell NHL, T-PLL, Mixed phenotypic leukemia (MPAL) with CD5 expression who have received at least 2 lines of standard chemo-immunotherapy or targeted therapy and have measurable persistent disease. For T-ALL active disease defined as (\\>5% of blasts or positive MRD at a level of \\>0.1% measured by multiparameter flow cytometry).\n2. Patients with history of T-lymphoid malignancies as defined above with relapsed disease following standard therapy or a stem cell transplant.\n\nB. Chronic lymphocytic leukemia (CLL) Chronic lymphocytic leukemia (CLL) small lymphocytic lymphoma (SLL), Richter's transformation of CLL or SLL who have received at least 2 lines of standard therapy or targeted therapy to include chemoimmunotherapy e.g. FCR, BTK inhibitors and a BCL-2 inhibitor and have persistent disease.\n\nC. Mantle cell lymphoma Relapsed or refractory mantle cell lymphoma after 2 lines of standard chemoimmunotherapy including a BTKi.\n\nExclusion criteria:\n\n1. Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.\n2. Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI.\n3. Presence of uncontrolled fungal, bacterial, viral, or other infection not responding to appropriate therapy.\n4. Active hepatitis B or C.\n5. HIV with detectable viral load.\n6. Presence of active neurological disorder(s).\n7. Active autoimmune disease within 12 months of enrollment\n8. Active cerebral or meningeal involvement by the malignancy\n9. Active (defined as requiring therapy) acute or chronic GVHD.\n10. Any other malignancy known to be active, except for treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.\n11. Presence of any other serious medical condition that may endanger the patient at investigator criteria.\n12. Major surgery \\\u003C4 weeks prior to first dose of study drug\n13. Allogeneic SCT or DLI \\\u003C12 weeks prior to first dose of study drug. Recipients of an allogeneic SCT patients should have discontinued all forms of immunosuppression at least 8 weeks prior enrollment in the study.\n14. Concomitant use of other investigational agents.\n15. Concomitant use of other anti-cancer agents.\n16. Patients receiving systemic steroid therapy at time of NK cell infusion (physiological substitutive doses are allowed) or have received ATG or lymphocyte immune globulin within 14 days or alemtuzumab within 3 months of enrollment.\n17. Patients receiving immunosuppressive therapy.\n18. Patients with diminished mental capacity will not be enrolled on the study.",{"count":479,"type":20},64,[72,23],"To determine the safety, efficacy and optimal cell dose of CAR 5\u002FIL15-transduced CB-NK cells in patients with relapsed\u002Frefractory T-cell malignances, mantle cell lymphoma, and chronic lymphocytic leukemia. The efficacy and optimal dose will be identified for individual diseases.",[483],"Hematological Malignancy",{"date":28,"type":31},{"date":486,"type":31},"2024-04-22",{"date":488,"type":20},"2030-12-31",{"name":37,"class":38},{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":21,"phases":499,"briefSummary":500,"conditions":501,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":504,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":104},"100321927","phase-1-ivosidenib-and-venetoclax-with-or-without-azacitidine-in-treating-patients-with-idh1-mutated-hematologic-malignancies-100321927","NCT03471260","Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies","Phase Ib\u002FII Investigator Initiated Study of the IDH1-Mutant Inhibitor Ivosidenib (AG120) With the BCL2 Inhibitor Venetoclax +\u002F- Azacitidine in IDH1-Mutated Hematologic Malignancies","Inclusion Criteria:\n\n1. Age \\> 18 years.\n2. ECOG performance status of \\\u003C 2.\n3. IDH1-R132 mutated disease status as assessed by local laboratory. 2HG-producing IDH1 variants outside of R132 (i.e. R100) may be eligible after discussion with the PI.\n4. Relapsed\u002Frefractory AML, or treatment-naïve patients with AML who are not eligible for standard induction chemotherapy. Patients with high-risk MDS, MDS\u002FMPN or MPN (defined as \\> 10% bone marrow blasts, or intermediate or high risk by IPSS, R-IPSS or D-IPSS) that have failed standard therapy may also be eligible after discussion with the PI.\n5. Adequate hepatic function (direct bilirubin \\\u003C 2 x ULN, ALT and\u002For AST \\\u003C 3x ULN) unless deemed to be related to underlying leukemia.\n6. Adequate renal function including creatinine clearance \\> 30 ml\u002Fmin based on the Cockcroft-Gault equation.\n7. Willing and able to provide informed consent\n8. In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 7 days for cytotoxic or non-cytotoxic (immunotherapy) agents.\n9. Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Patients with known allergy or hypersensitivity to ivosidenib or venetoclax.\n2. Patients who have previously received either ivosidenib or venetoclax.\n3. Patients with any concurrent uncontrolled clinically significant medical condition including infection, laboratory abnormality, or psychiatric illness, which could place the patient at unacceptable risk of study treatment.\n4. The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea and\u002For one dose of cytarabine (up to 2 g\u002Fm2) for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy.\n5. Patients receiving concomitant strong CYP3A inducers (avasimibe, carbamazepine, phenytoin, rifampin, rifabutin, St. John's wort) within 3 days of start of study therapy.\n6. Patients with active graft-versus-host-disease (GVHD) status post stem cell transplant (patients without active GVHD on chronic suppressive immunosuppression and\u002For phototherapy for chronic skin GVHD are permitted after discussion with the PI).\n7. Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.\n8. Patients with a concurrent active malignancy under treatment.\n9. QTc interval using Fridericia's formula (QTcF) \\> 450 msec. Bundle branch block and prolonged QTc interval are permitted after discussion with the PI.\n10. Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.\n11. Subject has a white blood cell count \\> 25 x 10⁹\u002FL. (Note: Hydroxyurea is permitted to meet this criterion.)\n12. Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception a. Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, IUD, and double barrier methods (for example a condom in combination with a spermicide).",{"count":498,"type":20},96,[72,23],"This phase Ib\u002FII trial studies the side effects and best dose of venetoclax and how well it works when given together with ivosidenib with or without azacitidine, in treating patients with IDH1-mutated hematologic malignancies. Venetoclax and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ivosidenib and venetoclax with azacitidine may work better in treating patients with hematologic malignancies compared to ivosidenib and venetoclax alone.",[117,502,76,503,118,120],"Hematopoietic and Lymphoid System Neoplasm","Myeloproliferative Neoplasm",{"date":28,"type":31},{"date":506,"type":31},"2018-03-19",{"date":508,"type":20},"2027-09-30",{"name":37,"class":38},""]