[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jonsson Comprehensive Cancer Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":597},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,69,0,25,[9,42,71,95,119,146,165,191,213,238,268,292,318,343,363,382,402,423,448,467,491,521,540,557,572],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100549286","phase-1-yttrium-90-y90-radioembolization-for-the-treatment-of-early-stage-renal-cell-carcinoma-the-renegade-trial-100549286",false,"NCT06432036","Yttrium-90 (Y90) Radioembolization for the Treatment of Early Stage Renal Cell Carcinoma, The RENEGADE Trial","RENEGADE: Radioembolization for Early Stage Renal Cell Carcinoma: An Open-Label, Prospective, Multi-Center, Phase 1\u002F2 Safety Trial","Inclusion Criteria:\n\n* Participants must be aged ≥ 18 years at the time of screening\n* Written informed consent and any locally required authorization (e.g., Health Insurance Portability and accountability Act) obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations\n* Life expectancy ≥ 12 months\n* RCC, diagnosed by radiographic imaging and histology\n* Clinical stage of RCC: T1 or T2a, Cancer stage (N0M0)\n* 1-2 solid (\\> 80% solid) target lesions\n* Patient not an ideal candidate for partial nephrectomy or thermal ablation at the time of study entry, based on the decision of the institution's multidisciplinary tumor board. Contraindications for partial nephrectomy include inability to potentially partially resect the kidney, high risk of adverse events due to medical comorbidities, or potential high risk of adverse events due to general anesthesia. Contraindications to thermal ablation include potential inability to technically place ablation probes into the tumor, central tumors which risk thermal injury to the renal collecting system\n* Patient not considered a candidate for long-term active surveillance due to oncologic risk due to tumor growth and\u002For tumor size\n* Patient not considered ideal candidates for radical nephrectomy due to surgical comorbidity and\u002For development of adverse health outcomes\n* Measurable tumor by RECIST 1.1 criteria\n* Absence of bilateral renal tumors\n* Negative serum pregnancy test in females of child-bearing potential; patients who are breast-feeding cannot participate in this trial\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Absolute neutrophil count ≥ 1.5 x 10\\^9\u002FL\n* Absolute lymphocyte count ≥ 1.0 x 10\\^9\u002FL\n* Platelet count ≥ 75 x 10\\^9\u002FL\n* Glomerular filtration rate (GFR) ≥ 45 mL\u002Fmin\u002F1.73 m\\^2\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment\n* Screening mapping angiogram demonstrates successful localization of tumor(s), where catheter placement location(s) would allow Y90 to distribute in the intended treatment area, without venous shunting\n\nExclusion Criteria:\n\n* Any contraindication to angiography or selective renal artery catheterization\n* Screening angiography with cone beam CT (CBCT) shows any arterial flow to the gastrointestinal tract uncorrectable by angiographic techniques\n* Screening angiography with CBCT shows poor tumor targeting that would lead to a dose that does not meet the renal dosing criteria. This typically occurs when a feeding artery to the tumor cannot be identified\n* Screening angiography demonstrates excessive non-tumoral renal parenchyma will be in the treatment field, that the new baseline glomerular filtration rate will be \\\u003C 45 mL\u002Fmin\u002F1.73 m\\^2\n* Screening angiography demonstrates renal venous shunting of iodinated contrast that is immediately visible upon arterial injection\n* Extra-renal metastases, including patients with abdominal lymph nodes \\>1.5 cm in shorter axis, or with lung nodules (single lesion, \\>1 cm, or multiple smaller lesions with a total diameter \\>2 cm)\n* Brain metastases, leptomeningeal carcinomatosis or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry\n* Evidence of any tumor invasion into the renal vein, renal artery, or renal collecting system\n* Any prior radiation therapy to the abdomen, including localized radiation therapy to the index tumor\n* Concurrent treatment for RCC or treatment in the last 6 months in another clinical study, unless it is an observational study (non-interventional) or during a non-interventional follow-up stage of an interventional study, or prior randomization to this study\n* History of active primary\u002Facquired immunodeficiency\n* Presence of renal ureteral stent in the treatment kidney at any time\n* History of malignancy, other than RCC, within three years, with the exception of adequately treatment carcinoma in situ of the cervix, early squamous cell carcinoma or basal cell carcinoma of the skin, localized prostate cancer, ductal carcinoma in situ, or low-grade endometrial carcinoma with no myometrial invasion (negligible risk of metastases or death 5-year overall survival \\[OS\\] rate \\> 90%)\n* Major surgical procedure (as defined by the Investigator) within 28 days prior to enrollment\n* A history of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically\n* Active infection\n* Female patients who are pregnant or breastfeeding or female patients of reproductive potential who are not willing to employ effective birth control from screening to 6 months after treatment\n* Unstable chronic disease or evidence of any disease or condition that would place the patient at undue risk and preclude safe use of Y90 microspheres, including but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent\n* History of pulmonary insufficiency, measured by oxygen saturation of less than 90%\n* Solitary kidney\n* Patient not able to follow the study protocol requirements","ALL","18 Years",{"count":7,"type":20},"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This phase I\u002FII trial tests the safety, side effects and effectiveness of radioembolization with yttrium-90 (Y-90) in patients with early stage renal cell carcinoma. Y-90 is a radioactive chemical that is incorporated into millions of very tiny glass spheres. These spheres are injected into the artery that feeds the cancer. This process is called radioembolization. Y-90 radioembolization may be a safe and effective treatment for patients with early stage renal cell carcinoma.",[27,28],"Stage I Renal Cell Cancer","Stage II Renal Cell Cancer","RECRUITING","2026-08-19",{"date":32,"type":33},"2026-08-21","ACTUAL",{"date":35,"type":33},"2024-12-26",{"date":37,"type":20},"2030-03",{"name":39,"class":40},"Jonsson Comprehensive Cancer Center","OTHER",2,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100637571","phase-1-ab801-in-combination-with-chemotherapy-and-immunotherapy-for-the-treatment-of-patients-with-borderline-resectable-locally-advanced-or-metastatic-cholangiocarcinoma-or-pancreatic-cancer-100637571","NCT07619313","AB801 in Combination With Chemotherapy and Immunotherapy for the Treatment of Patients With Borderline Resectable, Locally Advanced or Metastatic Cholangiocarcinoma or Pancreatic Cancer","A Phase 1\u002F1b Trial of AB801 in Combination With Chemotherapy and PD-1\u002FPD-L1 Blockade in Patients With Cholangiocarcinoma or Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n* Male or female ≥ 18 years of age and willing and able to provide informed consent\n* Previously untreated cytologically or histologically confirmed, at least one measurable lesion via Response Evaluation Criteria in Solid Tumors (RECIST 1.1) of cholangiocarcinoma or pancreatic adenocarcinoma meeting following criteria:\n\n  * Cholangiocarcinoma\n\n    * Borderline resectable\u002Flocally advanced cholangiocarcinoma: to be defined as unresectable disease on evaluation by a hepatobiliary multi-disciplinary tumor board\u002Fsurgeon based on tumor size\u002Flocation, vascular involvement, and absence of extrahepatic metastasis.\n    * Metastatic cholangiocarcinoma: Patients with metastatic cholangiocarcinoma patient who have not received prior systemic therapy\n  * Pancreatic adenocarcinoma\n\n    * Borderline resectable pancreatic adenocarcinoma: There are multiple definitions of borderline resectable pancreatic ductal adenocarcinoma (PDAC). For the purposes of this study, borderline resectable disease will be identified per the National Comprehensive Cancer Network (NCCN) criteria. Per this definition, borderline resectable PDAC is defined as the presence of any one or more of the following on CT:\n\n      * An interface between the tumor and superior mesenteric artery (SMA) or celiac axis (CA) measuring \\\u003C 180º of the circumference of the vessel wall.\n      * An interface between the tumor with the common hepatic artery without extension into the celiac axis or hepatic artery bifurcation allowing for safe and complete resection and reconstruction.\n      * An interface between the primary tumor and the superior mesenteric vein or portal vein (SMV-PV) measuring ≥ 180° of the circumference of the vessel wall\n      * Short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction\n      * An interface between the primary tumor and the inferior vena cava (IVC)\n    * Locally advanced pancreatic adenocarcinoma: Multiple guidelines defining locally advanced PDAC have been developed. For the purposes of this study, locally advanced PDAC cases will be identified per the definition developed by the NCCN. Per this definition, locally advanced PDAC is defined as presence of any one or more of the following on CT:\n\n      * Interface between the tumor and SMA or CV measuring \\> 180º of the circumference of the vessel wall or solid tumor contact with the CA and aortic involvement.\n      * Occlusion of the SMV-PV that is not amenable to resection and venous reconstruction\n  * Metastatic pancreatic adenocarcinoma: Patients with metastatic pancreatic adenocarcinoma who have not received prior systemic therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Absolute neutrophil count (ANC) ≥ 1.5x10\\^9\u002FL\n* Platelets ≥ 100x10\\^9\u002FL\n* Hemoglobin ≥ 9 g\u002FdL\n* Creatinine clearance (Ccr) ≥ 50 mL\u002Fmin (as calculated by Modified Cockcroft-Gault formula)\n* Serum total bilirubin ≤ 2x upper limit of normal (ULN) or \\\u003C 3x ULN if Gilbert's syndrome\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 2.5 X ULN; \\\u003C 5x ULN in patients with liver metastases\n* Women with no childbearing potential because of surgery or who are at least 1 year postmenopausal (ie, 12 months post last menstrual period) or with menopause confirmed by follicle-stimulating hormone testing, OR\n* Women of childbearing potential (defined as any female who has experienced menarche and is not permanently sterile or post-menopausal) must use an effective nonhormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap \\[diaphragm or cervical or vault caps\\] with spermicidal foam or gel or film or cream or suppository; or vasectomized male partner if he is the sole partner of that participant) or practice true abstinence for the duration of the study and for up to 14 months after the last systemic treatment\n* Male participants must use an effective method of contraception (condom or occlusive cap \\[diaphragm or cervical or vault caps\\] with spermicidal foam or gel or film or cream or suppository; or vasectomy) or practice true abstinence as defined throughout the study and for up to 11 months after the systemic treatment\n* Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses \\> 10 mg\u002Fday prednisone or equivalent) must be discontinued at least 2 weeks (14 days) before study treatment administration. Physiologic doses of corticosteroids (≤ 10 mg\u002Fday of prednisone or its equivalent) or short pulses of corticosteroids (≤ 3 days) may be permitted\n* Products with known potential to prolong the corrected QT (QTc) interval should be avoided when possible. When able will replace non-prolonging QTc acting drug when available and if medically necessary\n* Major surgery as defined by the Investigator must be completed at least 4 weeks before study treatment administration. Participants should have recovered from the surgical procedure prior to the first dose being administered\n* Adequate baseline tumor tissue sample for correlative studies\n\nExclusion Criteria:\n\n* Previous treatment with any of planned study drugs in cholangiocarcinoma, though patients with one cycle of gemcitabine\u002Fcisplatin\u002Fdurvalumab will be considered eligible\n* Previous treatment with any of planned study drugs in pancreatic adenocarcinoma, though patients with one cycle of FOLFIRINOX will be considered eligible\n* Peripheral neuropathy \\> grade 2\n* Known status of HIV which is not well-controlled (CD4 \\\u003C 300) at the time of study eligibility. Patients with controlled and treated HIV\u002Fhepatitis C virus (HCV) and an undetectable viral load are allowed\n* Untreated hepatitis B infection; Patient has known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection (testing is not mandatory, unless known active or known history of infection or required by local regulation):\n\n  * Participants with resolved or treated HCV (ie, HCV antibody positive but undetectable HCV ribonucleic acid \\[RNA\\]) will not be excluded from this study\n* Underlying medical conditions that, in the Investigator's opinion, will make the administration of investigational product (IP)(s) hazardous, including but not limited to:\n\n  * Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis\n  * Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of the IP,\n  * Active infection or antibiotics within 48 hours prior to study screening;\n  * A condition or unresolved adverse event (AE) from a prior investigational drug that may obscure the interpretation of toxicity determination or AEs,\n  * History of prior solid-organ transplantation\n* Any history of malignancy less than 5 years prior to the time of study eligibility (Patients with history of skin cancers excluding melanoma and cancers with a very low risk of recurrence i.e., low grade prostate cancer, thyroid cancer and low risk cervical cancer will be eligible for participation)\n* Serious medical comorbidities such as New York Heart Association Class III\u002FIV cardiac disease, uncontrolled cardiac arrhythmias, myocardial infarction over the past 12 months\n* Known family history or personal history of long QTc syndrome or previous drug-induced QTc prolongation of at least grade 3 (QTc \\> 500 ms)\n* Screening 12-lead electrocardiogram (ECG), in triplicate, with a measurable QTc interval of \\> 450ms\n* Known, existing uncontrolled coagulopathy. Patients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation are eligible IF: they are appropriately anticoagulated and have not had a grade 2 or greater bleeding episode in the 3 weeks before day 1\n* Known pregnancy, nursing women or positive pregnancy test. Requirement for women of childbearing potential (WOCBP): Negative serum pregnancy test at screening and serum or urine prior to dosing on cycle 1 day 1, within 24 hours prior to the start of treatment (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]). WOCBP must also have a negative serum or urine pregnancy test every 3 weeks, within 24 hours prior to the start of treatment\n* Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the investigator\n* History of trauma or major surgery within 28 days prior to the first dose of IP\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Any active or documented history of autoimmune disease, including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment, except for the following:\n\n  * Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders such as vitiligo, or alopecia not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger.\n  * Endocrinopathies where the participant is stable on hormone replacement therapy\n  * History of Hashimoto syndrome within 3 years of the first of study treatment that resolved to hypothyroidism alone",{"count":50,"type":20},46,[23],"This phase I trial tests the safety, side effects, best dose and effectiveness of AB801 in combination with chemotherapy and immunotherapy in treating patients with cholangiocarcinoma or pancreatic adenocarcinoma that may be removed by surgery (borderline resectable), that has spread to nearby tissue or lymph nodes (locally advanced), or that has spread from where it first started (primary site) to other places in the body (metastatic). AB801 is a drug designed to block a protein called AXL. AXL is found on the surface of certain cancer cells and plays an important role in helping tumors grow, spread to other parts of the body, and avoid the immune system. It is thought to contribute to resistance against common cancer treatments such as chemotherapy, radiation and immunotherapy. In many cancers, including cholangiocarcinoma and pancreatic adenocarcinoma, AXL is overactive and associated with worse outcomes. AB801 inhibits AXL which may make cancer cells more sensitive to chemotherapy and allow immune cells to better recognize and attack the tumor. Chemotherapy drugs, such as gemcitabine, cisplatin, oxaliplatin, irinotecan, leucovrin and fluorouracil, 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. Immunotherapy with monoclonal antibodies, such as durvalumab and zimberelimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving AB801 in combination with chemotherapy and immunotherapy may better treat patients with borderline resectable, locally advanced or metastatic cholangiocarcinoma or pancreatic adenocarcinoma.",[54,55,56,57,58,59,60,61],"Borderline Resectable Pancreatic Ductal Adenocarcinoma","Locally Advanced Cholangiocarcinoma","Locally Advanced Pancreatic Adenocarcinoma","Metastatic Cholangiocarcinoma","Metastatic Pancreatic Adenocarcinoma","Stage II Pancreatic Cancer AJCC v8","Stage III Pancreatic Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","2026-08-18",{"date":64,"type":33},"2026-08-20",{"date":66,"type":33},"2026-05-29",{"date":68,"type":20},"2028-06-01",{"name":39,"class":40},1,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":70},"100607681","phase-2-imlunestrant-and-abemaciclib-for-the-treatment-of-estrogen-receptor-positive-breast-cancer-in-patients-with-minimal-residual-disease-miri-trial-100607681","NCT07191717","Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Residual Disease, MIRI Trial","Phase II Minimal Residual Disease Study of Selective Estrogen Receptor Degrader Imlunestrant With Cyclin-Dependent Kinase (CDK) 4\u002F6 Inhibitor Abemaciclib in Patients With ER+ Breast Cancer (MIRI)","Inclusion Criteria:\n\n* Participants must have localized ER+ (≥ 10% on surgical pathology), HER2 negative, any grade, invasive breast cancer. Pathological stage (from time of surgery, including patients who received neoadjuvant therapy) I - III by American Joint Committee on Cancer (AJCC) 8th edition staging\n\n  * Note: Invasive breast cancer must be ER+ in ≥ 10% of the cells and HER2 negative (immunohistochemistry \\[IHC\\] 0 or 1+ and\u002For fluorescence in situ hybridization \\[FISH\\] negative with a ratio \\\u003C 2) by American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines. For Immunohistochemistry (IHC) 2+, the tumor must be FISH negative with a ratio \\\u003C 2. ER, progesterone receptor (PR) and HER2 measurements should be performed according to institutional (local) guidelines, in a Clinical Laboratory Improvement Act (CLIA)-approved setting\n* Detectable ctDNA in a CLIA-certified lab (separate pre-screening consent available) within the past six months. Participants must have no clinical or radiographic evidence of recurrence as determined by the treating investigator\n* Confirmation of adequate archival tissue (either initial biopsy or surgical specimen) (15-20 unstained slides cut at 5 µm or 1 block) required before study entry. If adequate surgical tissue is available, this is preferred. Otherwise tissue from diagnostic biopsy is acceptable. If adequate tissue not available, principal investigator (PI) approval is required prior to study entry\n* No prior history of other malignancies within past 5 years (besides breast cancer as per inclusion #1). Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin. No concurrent malignancy or other serious medical condition as deemed by the investigator\n* Participants may or may not have received (neo)adjuvant chemotherapy and\u002For biological therapy at the time of screening, with no more than grade 1 residual toxicity (except ≤ grade 2 neuropathy or ≤ grade 2 alopecia)\n* Participants may or may not have received adjuvant radiotherapy, with no more than grade 1 residual toxicity\n* Pre- and postmenopausal women and men are eligible. Premenopausal women must have a negative serum pregnancy test at time of screening\n\n  * Pregnancy testing does not need to be pursued in female patients who are:\n\n    * Age ≥ 60 years; OR\n    * Age \\\u003C 60 with intact uterus AND amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range\n    * OR status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation\n* Must be ≥ 18 years of age\n* History of CDK 4\u002F6 inhibitor is permitted provided the last dose was more than 6 months ago (from consent date)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky ≥ 70%)\n* Patients must currently be on endocrine therapy in the adjuvant setting and must have received (neo) adjuvant endocrine therapy for at least 24 months (cumulative duration)\n* Ability to understand and the willingness to sign a written informed consent document. Patient must sign the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements\n* Participants must currently be receiving adjuvant endocrine therapy and have been on adjuvant endocrine therapy for at least 2 years. Adjuvant endocrine therapy can be either tamoxifen or aromatase inhibitor (AI), i.e prior use of any AI, including letrozole, anastrozole or exemestane, or tamoxifen is allowed. Concurrent gonadotrophin releasing hormone (GNRH) agonist is required with AI in pre - and\u002For peri-menopausal patients and men\n* Absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL\n* Platelets ≥ 100 × 10\\^9\u002FL\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Serum creatinine \\\u003C 1.5 mg\u002FdL OR creatinine clearance ≥ 50 mL\u002Fmin\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 2.5 x institutional upper limit of normal (ULN)\n* Total bilirubin \\\u003C institutional 1.5 times ULN; or total bilirubin ≤ 3.0 x institutional ULN. Patients with Gilbert's Syndrome with a total bilirubin ≤ 2.0 times ULN and direct bilirubin within normal limits are permitted\n* The patient is able to swallow oral medications\n\nExclusion Criteria:\n\n* Participants with metastatic disease (including contralateral axillary lymph nodes) or inflammatory breast cancer. Of note, if a patient had locally advanced breast cancer leading to inflammation, this would not exclude the patient on the grounds of inflammatory carcinoma\n* Participants who have had CDK 4\u002F6 inhibitor therapy within the past 6 months. Use of prior CDK 4\u002F6 inhibitor with last dose more than 6 months ago is permitted\n* Participants who are receiving any other anti-cancer investigational agents. Participation in other observational studies is permitted\n* History of other malignancies within past 5 years, except ductal carcinoma in situ of the breast, cervical cancer in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin. No concurrent malignancy or other serious medical condition as deemed by the investigator\n* Herbal products and supplements will generally not be allowed, but specific supplements (such as cannabidiol \\[CBD\\] oil) can be considered on a case-by-case basis by Overall PI\n* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment (e.g. estimated creatinine clearance \\\u003C 30ml\u002Fmin), unstable angina pectoris, cardiac arrhythmia, a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. Patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, stomach resection, or small bowel resection) are ineligible. Patient with active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]). Screening for HIV and hepatitis is not required for enrollment\n* The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n* A history of venous thromboembolism (VTE): deep vein thrombus or pulmonary embolism. An exception can be made for patients with a history of an uncomplicated venous catheter-related occlusion. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n* History of hypersensitivity to imlunestrant, abemaciclib or any of the components in either medication\n* HIV-positive participants not on antiretroviral therapy are at increased risk of lethal infections when treated with marrow-suppressive therapy and should not be enrolled until their HIV is managed. If the HIV is well controlled, participants may participate in this study\n* Pregnant women are excluded from this study because embryo-fetal toxicity is a potential side effect of abemaciclib and imlunestrant. For this reason, women of child-bearing potential (WOCBP) and men must agree to use highly effective contraception prior to study entry, for the duration of treatment, and for at least 3 months after the completion of treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential. All WOCBP must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of the investigational agent(s). Registration may occur prior to this pregnancy test. If the pregnancy test is positive, the patient must not receive protocol treatment and must not continue in the study. WOCBP is defined as follows:\n\n  * Any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or a bilateral oophorectomy) OR\n  * Any female who is not postmenopausal defined as:\n\n    * Age ≥ 60 years; OR\n    * Age \\\u003C 60 with intact uterus AND amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; OR\n    * Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 12 weeks after study drug discontinuation. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential. Highly effective contraception methods include:\n\n  * Total abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n  * Female sterilization (surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\n  * Use of non-estrogen oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example hormone vaginal ring or transdermal hormone contraception\n  * Use of luteinizing hormone-releasing hormone (LHRH) agonist with estrogen level in post-menopausal range and one form of barrier method contraception\n* Women who are lactating. Advise lactating women to not breastfeed during treatment and for 1 week after last dose",{"count":79,"type":20},42,[24],"This phase II trial studies how well imlunestrant and abemaciclib work in treating patients with estrogen receptor positive (ER+) breast cancer who have tumor remaining in the blood following treatment (minimal residual disease). Estrogen can cause the growth of breast cancer cells. Imlunestrant lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Imlunestrant and abemaciclib may be effective in treating patients with ER+ breast cancer who have minimal residual disease.",[83,84,85,86,87,88],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","Invasive Breast Carcinoma","Localized Estrogen Receptor-Positive Breast Carcinoma","Localized Human Epidermal Growth Factor Receptor (HER2)-Negative Breast Carcinoma",{"date":64,"type":33},{"date":91,"type":33},"2026-05-18",{"date":93,"type":20},"2031-04-30",{"name":39,"class":40},{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":103,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":106,"studyType":107,"phases":4,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":70},"100598880","prostate-cancer-postoperative-stereotactic-body-radiotherapy-with-adaptive-technology-for-minimizing-toxicity-100598880","NCT07077239","Prostate Cancer Postoperative Stereotactic Body Radiotherapy With Adaptive Technology for Minimizing Toxicity","MAgnetic Resonance Imaging or Computed Tomography Guided Stereotactic Body Radiotherapy With Online Adaptive Technology for Minimizing Toxicity During Salvage or AdjUvaNt Radiotherapy for ProstatE Cancer (MASAMUNE)","MASAMUNE","Inclusion Criteria\n\n* History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent.\n* Presence of any ONE of the following:\n\n  1. Adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, OR presence of tertiary Gleason grade 5 disease)\n  2. Documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng\u002FmL\n  3. Intermediate- or high-risk Decipher genomic classifier score\n  4. Identification of prostate cancer in ≥1 lymph node at the time of prostatectomy (pN+ disease)\n* CT scan and MRI of the pelvis within 120 days prior to enrollment \\[note: (a) if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed; (b) for patients with PSA \\\u003C1.0 ng\u002FmL, the treatment planning CT can substitute for a diagnostic CT scan; (c) a low-field, radiation planning MRI can replace the diagnostic MRI if the patient refuses or cannot obtain a high-field MRI\\].\n* Bone scan OR advanced nuclear imaging study within 120 days prior to enrollment for patients with PSA \\>1.0 ng\u002FmL.\n* Age ≥ 18.\n\n  \\~. KPS ≥ 70 and\u002For ECOG \\\u003C2.\n* Ability to understand, and willingness to sign, the written informed consent\n\nExclusion Criteria\n\n* Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator.\n\n  * Patients with neuroendocrine or small cell carcinoma of the prostate\n  * Prior pelvic radiotherapy\n* History of Crohn's Disease, Ulcerative Colitis, or Ataxia Telangiectasia","MALE",{"count":105,"type":20},200,"5 Years","OBSERVATIONAL","Single-arm, prospective registry study assessing changes in acute patient-reported urinary (GU) and gastrointestinal (GI) quality of life at the 24-month post-treatment time point following magnetic resonance imaging (MRI)-guided or computed tomography (CT)-guided stereotactic body radiotherapy (SBRT) delivered to the prostate bed +\u002F- pelvic lymph nodes. The decision to offer an adaptive treatment will be at the clinician's discretion.",[110],"Prostate Cancer (CRPC)",[112],"prostatectomy",{"date":64,"type":33},{"date":115,"type":33},"2025-07-17",{"date":117,"type":20},"2036-08-01",{"name":39,"class":40},{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":127,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":21,"phases":130,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":70},"100557455","hypofractionated-external-beam-radiotherapy-with-adaptive-planning-for-endometrial-and-cervical-cancers-100557455","NCT06538337","Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers","Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers (HERA Trial)","HERA","Inclusion Criteria:\n\n* Histologically confirmed endometrial or cervical cancer\n* Surgical resection of the primary tumor\n* International Federation of Gynecology and Obstetrics (FIGO) Stage IA-IVB endometrial cancer OR FIGO Stage IA-IIA cervical cancer that meets indications for receiving adjuvant pelvic radiotherapy alone as standard of care\n* Age ≥ 18 years old\n* Karnofsky performance status (KPS) ≥ 60 or Eastern Cooperative Oncology Group (ECOG) 0-2\n\nExclusion Criteria:\n\n* Must not meet indications for receiving concurrent chemotherapy as standard of care\n* Active treatment of a separate malignancy\n* History of prior irradiation to the area to be treated","FEMALE",{"count":129,"type":20},60,[131],"NA","After surgery to remove the main endometrial and\u002For cervical tumor, most women receive radiation therapy. This study uses hypo-fractionated radiation therapy, which is a type of radiation therapy in which the total prescribed dose of radiation is delivered in fewer but larger doses than conventional or standard radiotherapy.\n\nThis research study aims to determine if hypo-fractionated radiation therapy given after surgery can improve treatment tolerability (i.e., fewer treatments) with comparable side effects.\n\nParticipants will be in the study for about 5 years:\n\nRadiation therapy:\n\n* 5 daily treatment sessions of MRI or CT-Guided Stereotactic Body Radiation Therapy (SBRT).\n* Each treatment session will occur on a weekday (typically consecutive weekdays) and will last approximately an hour.\n\nTreatment Follow-Up:\n\n* Check-up Appointment and answer questions at 3 months post RT\n* Check-up Appointments with physical exam every 6 months (+\u002F- 4 weeks) for up to 5 years.",[134,135],"Endometrial Cancer","Cervical Cancer",[137,138,139],"endometrial","cervical","SBRT",{"date":64,"type":33},{"date":142,"type":33},"2024-07-24",{"date":144,"type":20},"2032-07-26",{"name":39,"class":40},{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":21,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":70},"100533376","phase-1-fluoxetine-for-the-modification-of-colorectal-tumor-immune-cells-before-surgery-in-patients-with-colorectal-cancer-100533376","NCT06225011","Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer","Repurposing Drugs as Immunotherapeutic Agents: Changes in Colorectal Tumor Immune Cells After Targeting Serotonin","Inclusion Criteria:\n\n* Male or female ≥ 18 years of age at visit 1\n* Previously untreated cytologically or histologically confirmed colorectal adenocarcinoma that will not need neoadjuvant therapy\n* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study\n* World Health Organization (WHO) Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Absolute neutrophil count (ANC) ≥ 1.5x10\\^9\u002FL\n* Platelets ≥ 100x10\\^9\u002FL\n* Hemoglobin ≥ 9 g\u002FdL\n* Serum creatinine (sCr) ≤ 1.5 x upper limit of normal (ULN)\n* Creatinine clearance (Ccr) ≥ 40 mL\u002Fmin (as calculated by Modified Cockcroft-Gault formula)\n* Serum total bilirubin ≤ 1.5 x ULN\n* Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \\[SGOT\\]) \u002F alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 2.5 x ULN\n* Baseline corrected QT (QTc) within normal limits per the Bazett formula. Any electrocardiogram (EKG) done prior to consent is acceptable for baseline QTc monitoring.\n\n  * Normal QTc ranges from 350-450 ms for adult men and from 360-460 ms for adult women\n\nExclusion Criteria:\n\n* Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the participant or the quality of the data\n* A diagnosis of metastatic colorectal adenocarcinoma\n* Individuals who have received neoadjuvant chemotherapy prior to the planned colon cancer resection\n* Individuals with absolute or relative contraindications to fluoxetine\n\n  * Baseline prolonged QTc\n  * Concurrently taking tamoxifen, pimozide, or thioridazine\n* Individuals using other SSRIs, serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), lithium or other antidepressants at time of initial biopsy\n* Currently active second primary malignancy or history of malignancy less than 5 years prior to the time of study eligibility (Patients with history of skin cancers excluding melanoma will be eligible for participation)",{"count":154,"type":20},10,[23],"This phase I trial tests whether fluoxetine (prozac) works to modify the tumor immune cells before surgery in patients with colorectal cancer. Fluoxetine is a commonly used selective serotonin reuptake inhibitor (SSRI) prescribed for major depressive disorder and generalized anxiety. Giving fluoxetine may modify the immune cell composition in the tumor and its microenvironment and may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread in patients with colorectal cancer.",[158],"Colorectal Adenocarcinoma",{"date":64,"type":33},{"date":161,"type":33},"2025-03-20",{"date":163,"type":20},"2028-07-01",{"name":39,"class":40},{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":103,"minAge":18,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":190,"locationsCount":70},"100435087","high-dose-rate-brachytherapy-and-stereotactic-body-radiotherapy-for-the-treatment-of-prostate-adenocarcinoma-100435087","NCT04945642","High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma","Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)","HYDRA","Inclusion Criteria:\n\n* Ability to understand a written informed consent document, and the willingness to sign it\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* History\u002Fphysical examination with digital rectal examination of the prostate within 8 weeks prior to registration\n* Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA \\> 10, and\u002For Gleason score \\>= 7\n* No evidence of disease beyond the prostate and\u002For seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis)\n* Prostate size =\\\u003C 60cc\n* International Prognostic Scoring System (IPSS) score =\\\u003C 15\n* Able to safely receive moderate sedation or general anesthesia\n\nExclusion Criteria:\n\n* Patients with neuroendocrine or small cell carcinoma of the prostate\n* Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous\u002Fhematogenous malignancy unless continually disease free for a minimum of 5 years\n* Regional lymph node involvement\n* Evidence of distant metastases\n* Previous radical surgery (prostatectomy) or cryosurgery or high-intensity focused ultrasound for prostate cancer\n* Previous pelvic irradiation or prostate brachytherapy\n* Previous or concurrent cytotoxic chemotherapy for prostate cancer\n* Patients with history of inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), high predisposition for radio-toxicity compared to general population (i.e., ataxia telangiectasia), or at risk for major bowel surgery\n* Transurethral resection of the prostate (TURP) procedure within 6 months of radiation treatment",{"count":174,"type":20},52,[131],"This phase II trial investigates the effect of high dose-rate brachytherapy and stereotactic body radiotherapy in treating patients with prostate adenocarcinoma. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.",[178,179,180,181,182,183,184,185],"Prostate Adenocarcinoma","Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8","Stage IIC Prostate Cancer AJCC v8","Stage III Prostate Cancer AJCC v8","Stage IIIA Prostate Cancer AJCC v8","Stage IIIB Prostate Cancer AJCC v8","Stage IIIC Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8",{"date":64,"type":33},{"date":188,"type":33},"2021-08-20",{"date":163,"type":20},{"name":39,"class":40},{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},"100332050","phase-2-pembrolizumab-in-treating-participants-with-leukoplakia-100332050","NCT03603223","Pembrolizumab in Treating Participants With Leukoplakia","A Phase II Open Label, Single Arm Study to Evaluate the Efficacy of Pembrolizumab for Leukoplakia","Inclusion Criteria:\n\n* Be willing and able to provide written informed consent\u002Fassent for the trial.\n* Subjects must have leukoplakia, erythroleukoplakia or proliferative verrucous leukoplakia (PVL) with lesions measurable in 2 dimensions, not amenable to surgical resection or radiation or who have refused surgery or radiation. Patients must have at least 1 lesion that can be followed on treatment. (Patients who have undergone complete excision of lesions and are clinically without evidence of disease will not be eligible for study.)\n* Evidence of moderate or severe dysplasia or carcinoma in situ.\n* Baseline biopsy specimen available for biomarker analysis or willingness to undergo fresh baseline biopsy.\n* Willingness to consent to photographs of lesions.\n* Willingness to undergo biopsy at 6 months.\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale.\n* Absolute neutrophil count (ANC) \\>= 1,500 \u002FmcL within 10 days of treatment initiation.\n* Platelets \\>= 100,000\u002FmcL within 10 days of treatment initiation.\n* Hemoglobin \\>= 9 g\u002FdL or \\>= 5.6 mmol\u002FL without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment).\n* Serum creatinine =\\\u003C 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) \\>= 60 mL\u002Fmin for subject with creatinine levels \\> 1.5 X institutional ULN within 10 days of treatment initiation. (Glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or CrCl).\n\n  * Creatinine clearance should be calculated per institutional standard.\n* Serum total bilirubin =\\\u003C 1.5 X ULN OR direct bilirubin =\\\u003C ULN for subjects with total bilirubin levels \\> 1.5 ULN within 10 days of treatment initiation.\n* Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamate pyruvate transaminase (SGPT) =\\\u003C 2.5 X ULN OR =\\\u003C 5 X ULN for subjects with liver metastases within 10 days of treatment initiation.\n* Albumin \\>= 2.5 mg\u002FdL within 10 days of treatment initiation.\n* International normalized ratio (INR) or prothrombin time (PT) =\\\u003C 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants. (Within 10 days of treatment initiation.)\n* Activated partial thromboplastin time (aPTT) =\\\u003C 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants. (Within 10 days of treatment initiation.)\n* Female subject of childbearing potential should have a negative urine or serum pregnancy within 10 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n* Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n\nExclusion Criteria:\n\n* Patients with leukoplakia, erythroleukoplakia or PVL who have only mild dysplasia or hyperplasia are excluded.\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy \\> prednisone 10 mg daily or equivalent, or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Has a known history of active TB (Bacillus tuberculosis).\n* Hypersensitivity to pembrolizumab or any of its excipients.\n* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =\\\u003C grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =\\\u003C grade 1 or at baseline) from adverse events due to a previously administered agent.\n\n  * Note: Subjects with =\\\u003C grade 2 neuropathy are an exception to this criterion and may qualify for the study.\n  * Note: If subject received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.\n* Has 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 not considered a form of systemic treatment.\n* Has known history of, or any evidence of active, non-infectious pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject?s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.\n* Has a known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies).\n* Has known active hepatitis B (e.g., hepatitis B virus surface antigen \\[HBsAg\\] reactive) or hepatitis C virus (e.g., HCV ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected).\n* Has received a live vaccine within 30 days of planned start of study therapy.\n\n  * Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed.",{"count":199,"type":20},26,[24],"This phase II pilot trial studies how well pembrolizumab works in treating leukoplakia. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.",[203,204,205],"Erythroleukoplakia","Leukoplakia","Verrucous Oral Leukoplakia",{"date":64,"type":33},{"date":208,"type":33},"2019-05-03",{"date":210,"type":20},"2028-08-01",{"name":39,"class":40},3,{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":237},"100557858","phase-1-external-beam-radiation-therapy-and-brachytherapy-with-chemotherapy-and-immunotherapy-for-the-treatment-of-stage-ivb-cervical-cancer-100557858","NCT06543576","External Beam Radiation Therapy and Brachytherapy With Chemotherapy and Immunotherapy for the Treatment of Stage IVB Cervical Cancer","A Prospective Cohort Study of Integrating Radiotherapy Into Chemotherapy With Pembrolizumab and Bevacizumab in Newly Diagnosed Stage IVB Cervical Cancer","Inclusion Criteria:\n\n* Participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of Stage IVB cervical cancer will be enrolled in this study\n* Patients with stage IVB adenocarcinoma, adenosquamous carcinoma, or squamous-cell carcinoma of the cervix that has not yet been treated with systemic chemotherapy or radiation therapy\n* Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤ grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤ grade 2 neuropathy are eligible\n* The participant provides written informed consent for the trial\n* Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions\n* Archival tumor tissue sample or newly obtained \\[core, incisional or excisional\\] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue\n* Patients must have PD-L1 status, CPS score of over 1. PD-L1 status will be determined per institutional standards via the Food and Drug Administration (FDA)-approved test, Dako PD-L1 immunohistochemistry (IHC) 22C3 pharmDx kit with combined positive score (CPS) interpretation\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.\n\nNote: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.\n\nHepatitis B screening tests are not required unless:\n\n* Known history of HBV infection\n* As mandated by local health authority\n\n  * Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n\nNote: Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization. Hepatitis C screening tests are not required unless:\n\n* Known history of HCV infection\n* As mandated by local health authority\n\n  * HIV-infected participants must have well-controlled HIV on antiretroviral treatment (ART), defined as:\n* Participants on ART must have a CD4+ T-cell count ≥ 350 cells\u002Fmm\\^3 at the time of screening\n* Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV ribonucleic acid (RNA) level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening\n* It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n* Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (day 1) and agree to continue ART throughout the study\n* The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors\u002Finducers\u002Fsubstrates (https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers)\n\n  * Absolute neutrophil count (ANC) ≥ 1500\u002FµL (collected within 10 days prior to the start of study)\n  * Platelets ≥ 100 000\u002FµL (collected within 10 days prior to the start of study)\n  * Hemoglobin ≥ 9.0 g\u002FdL or ≥ 5.6 mmol\u002FL (collected within 10 days prior to the start of study). Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\n  * Creatinine ≤ 1.5 × upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or creatinine clearance \\[CrCl\\]) ≥ 30 mL\u002Fmin for participant with creatinine levels \\> 1.5 × institutional ULN (collected within 10 days prior to the start of study)\n* Creatinine clearance (CrCl) should be calculated per institutional standard\n\n  * Total bilirubin ≤ 1.5 × ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN (collected within 10 days prior to the start of study)\n  * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases) (collected within 10 days prior to the start of study)\n  * International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (collected within 10 days prior to the start of study)\n\nExclusion Criteria:\n\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)\n* Has received prior hysterectomy. (Prior lymphadenectomy permitted)\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks to \u002Fallocation\n* Has received prior radiotherapy for cervical cancer\n* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤ 6, and prostate specific antigen (PSA) \\\u003C 10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded\n* Has known active carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention\n* Has severe hypersensitivity (≥ grade 3) to pembrolizumab and\u002For any of its excipients\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has an active infection requiring systemic therapy\n* History of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as detectable HCV RNA \\[qualitative\\]) infection.\n\nNote: Testing for Hepatitis B or C is not required unless mandated by local health authority\n\n* Has not adequately recovered from major surgery or has ongoing surgical complications\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment\n* Has had an allogenic tissue\u002Fsolid organ transplant\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease",{"count":221,"type":20},35,[23,24],"This phase I\u002FII trial tests the safety and effectiveness of receiving external beam radiation therapy (EBRT) and brachytherapy along with chemotherapy, consisting of cisplatin and paclitaxel, and immunotherapy, consisting of bevacizumab and pembrolizumab, for the treatment of patients with stage IVB cervical cancer. EBRT is type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. A monoclonal antibody, such as pembrolizumab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving EBRT and brachytherapy along with chemotherapy and immunotherapy may be a safe and effective way to treat patients with stage IVB cervical cancer.",[225,226,227,228],"Cervical Adenocarcinoma","Cervical Adenosquamous Carcinoma","Cervical Squamous Cell Carcinoma","Stage IVB Cervical Cancer American Joint Committee on Cancer (AJCC) v8","2026-08-10",{"date":231,"type":33},"2026-08-12",{"date":233,"type":33},"2025-07-29",{"date":235,"type":20},"2032-01-31",{"name":39,"class":40},4,{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":21,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":259,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":70},"100648145","phase-1-mercaptopurine-for-the-treatment-of-hereditary-leiomyomatosis-and-renal-cell-carcinoma-hlrcc-uterinecutaneous-leiomyomas-and-kidney-cancer-100648145","NCT07716735","Mercaptopurine for the Treatment of Hereditary Leiomyomatosis and Renal Cell Carcinoma (HLRCC), Uterine\u002FCutaneous Leiomyomas, and Kidney Cancer","Mercaptopurine (6-MP) for the Treatment of Manifestations of Hereditary Leiomyomatosis and Renal Cell Carcinoma (HLRCC)","Inclusion Criteria:\n\n* Age ≥ 18\n* Disease-causing, germline FH mutation including variants considered either:\n\n  * a) Pathogenic\u002Flikely pathogenic OR\n  * b) variants of unknown significance (VUS) with immunohistochemical staining showing loss of FH or high 2-SC expression in tumor tissue\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1\n* Thiopurine S-methyltransferase (TPMT) and NUDT15 homozygous, wild-type genotype\n\n  * TPMT\\*1\u002FTPMT\\*1 and NUDT15\\*1\u002F NUDT15\\*1\n* Calculated creatinine clearance ≥ 30 milliliters per minute (mL\u002Fmin) per the Cockcroft and Gault formula OR serum creatinine \\\u003C 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\\u003C 3 x ULN (\\\u003C 5 x ULN if liver metastases are present)\n* Total bilirubin \\\u003C 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin up to 3.0 mg\u002FdL)\n* Albumin ≥ 2.2 mg\u002FdL\n* White blood cells (WBC) \\> 2,000\u002Fmm\\^3\n* Hemoglobin (Hb) ≥ 9\n* Neutrophils \\> 1,500\u002Fmm\\^3\n* Platelets \\> 100,000\u002Fmm\\^3\n* Inclusion into ≥ 1 of the following symptomatic, disease states listed below:\n\n  * Inclusion allows entry into that cohort for efficacy assessments. Patients can be in ≥ 1 cohort if they have more than one disease manifestation fitting the below criteria. If a patient fits inclusion\u002Fexclusion into one cohort and has disease manifestations that are excluded from another cohort, they can still participate in the trial but will not be assessed for efficacy for that specific disease manifestation\n* KIDNEY CANCER COHORT: Advanced, metastatic kidney cancer disease\n* KIDNEY CANCER COHORT: Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria\n* KIDNEY CANCER COHORT: ≥ 1 lines of systemic therapy (not considering adjuvant)\n* UTERINE FIBROIDS COHORT: Age ≥ 18\n* UTERINE FIBROIDS COHORT: Female biologic sex\n* UTERINE FIBROIDS COHORT: Any pre-menopausal patient\n* UTERINE FIBROIDS COHORT: Fibroid-associated symptoms including symptomatic menorrhagia and\u002For pelvic pain\u002Fpressure\n* UTERINE FIBROIDS COHORT: Estimated ≤ 15-week uterus by bimanual exam OR by radiographic parameters (≤ 10 cm max dimension of largest fibroid or estimated weight ≤ 400 g)\n* UTERINE FIBROIDS COHORT: Be willing to use non hormonal contraception if needed\n* CUTANEOUS LEIOMYOMAS COHORT: ≥ 5 cutaneous leiomyomas\n* CUTANEOUS LEIOMYOMAS COHORT: Leiomyoma-associated pain or paresthesia causing weekly pain ≥ 4\u002F10 on a pain scale\n\nExclusion Criteria:\n\n* Absolute contraindication to the use of contrast-enhanced imaging for efficacy assessment. If moderate allergy, patients could be allowed if pre-medication can be given to limit adverse reactions. (\\*Not relevant for skin-only cohort)\n* Presence of untreated brain metastases. Treated brain metastases must be stable for 4 weeks after treatment, have no clinical symptoms, and not be on corticosteroids \\> 10 mg\u002Fday of prednisone-equivalent \\> 2 weeks prior to treatment. Patients with known leptomeningeal metastases are excluded\n* Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive medications within 14 days prior to first dose of study drug. An exception is allowed for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll. Inhaled steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease\n* History of myocarditis or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry\n* Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or interfere with the interpretation of safety results\n* Individuals who are pregnant; negative serum pregnancy tests in patients of childbearing potential and consent to an effective contraceptive method (if needed Centers for Disease Control and Prevention \\[CDC\\] guidelines provided) until a minimum of 30 days after cessation of therapy\n* Individuals who wish to continue actively breast-feeding must agree to not breastfeed during the study or for 180 days after the last dose of study treatment\n* An untreated non-renal malignancy with the following exceptions:\n\n  * low risk prostate cancer on active surveillance (National Comprehensive Cancer Network \\[NCCN\\] very low\u002Flow risk)\n  * non-melanoma skin cancer\n* Any prior treated, non-renal malignancy except for those meeting the following characteristics:\n\n  * Treated stage I or II cancer from which the patient is currently in complete remission\n  * Stage III cancer in remission for \\> 2 years and is not receiving any current treatment\n  * A hematologic malignancy from which the patient is considered to be in complete remission\n* UTERINE FIBROIDS COHORT: Hormonal management ≤ 2 months of starting treatment. Including gonadotrophin releasing hormone (GnRH) analog, progestins or estrogen (pills or intrauterine devices), or ulipristal acetate\n* UTERINE FIBROIDS COHORT: GnRH analog usage ≤ 12 months of starting treatment\n* UTERINE FIBROIDS COHORT: History of uterine artery embolization\n* UTERINE FIBROIDS COHORT: Prior radiofrequency ablation to a target lesion\n* UTERINE FIBROIDS COHORT: History of MR guided focused ultrasound\n* UTERINE FIBROIDS COHORT: Myomectomy ≤ 1 year of starting therapy\n* UTERINE FIBROIDS COHORT: Concern for gynecologic malignancy\n* UTERINE FIBROIDS COHORT: Any Federation of Gynecology and Obstetrics (FIGO) 1 or FIGO 2 myomas requiring immediate treatment\n* UTERINE FIBROIDS COHORT: Planning pregnancy in the next 6 months\n* UTERINE FIBROIDS COHORT: History of endometrial ablation\n* UTERINE FIBROIDS COHORT: Hormonal intrauterine device (IUD) in place\n* CUTANEOUS LEIOMYOMAS COHORT: Willingness\u002Fability to have all cutaneous lesions completely removed",{"count":246,"type":20},18,[23],"This phase I\u002FII trial studies the side effects and best dose of mercaptopurine, and to see how well it works in treating patients with hereditary leiomyomatosis and renal cell carcinoma (HLRCC). HLRCC is a rare inherited disorder that increases the risk of developing benign (not cancer) tumors of the skin and the uterus (leiomyomas) and malignant (cancer) tumors of the uterus (leiomyosarcoma) and the kidney. Mercaptopurine is in a class of medications called purine antagonists. It works by stopping the growth of cancer cells.",[250,251,252,253,254,255,256,257,258],"Advanced Kidney Carcinoma","Advanced Renal Cell Carcinoma","Hereditary Leiomyomatosis and Renal Cell Carcinoma","Metastatic Kidney Carcinoma","Metastatic Renal Cell Carcinoma","Skin Leiomyoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Uterine Corpus Leiomyoma","NOT_YET_RECRUITING","2026-08-04",{"date":262,"type":33},"2026-08-06",{"date":264,"type":20},"2026-12-01",{"date":266,"type":20},"2035-12-01",{"name":39,"class":40},{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":127,"minAge":4,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":21,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":291},"100524767","phase-2-prevention-of-frailty-with-fisetin-and-exercise-in-breast-cancer-survivors-100524767","NCT06113016","Prevention of Frailty With Fisetin and Exercise in Breast Cancer Survivors","A Phase II Randomized Placebo-Controlled Study of Fisetin and Exercise to Prevent Frailty in Breast Cancer Survivors","PROFFi","Inclusion Criteria:\n\n* Women who are postmenopausal at the start of study treatment\n\n  * Postmenopausal status will be established as follows: Women who are 50 years or older and who are not menstruating for greater than 12 months will be considered postmenopausal. Women who are less than 50 years with an intact uterus and ovaries must have chemically induced menopause (e.g., ovarian suppression) to be considered postmenopausal\n* Women with a diagnosis of early-stage breast cancer (stage I, II, III) treated with neo\u002Fadjuvant chemotherapy within 12 months of starting study treatment\n* No evidence of active\u002Frecurrent breast cancer or other serious chronic illnesses\n* Have evidence of pre-frail health, defined as a 6-minute walk distance (400-480m) at baseline\n* Platelets \\> 60,000\u002Fmm\\^3\n* White blood cell count \\> 2,000\u002Fmm\\^3\n* Absolute neutrophil count \\> 500\u002Fmm\\^3\n* Hemoglobin ≥ 8.0 g\u002FdL\n* Total bilirubin ≤ 3.0 X upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) ≤ 4.0 x ULN\n* Alanine aminotransferase (ALT) ≤ 4.0 x ULN\n* Estimated glomerular filtration rate (eGFR) of ≥ 30mL\u002Fmin\u002F1.73m\\^2 per the Modification of Diet in Renal Disease (MDRD) calculation. GFR (mL\u002Fmin\u002F1.73 m²) = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American)\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Cancer-directed chemotherapy, biological therapy, or immunotherapy within 30 days prior to the start of study treatment. Exceptions include: trastuzumab, pertuzumab, pembrolizumab, tamoxifen, and aromatase inhibitors\n* Surgery and\u002For radiation within the last 30 days of starting study treatment (Exception: invasive non-major procedures such as an outpatient biopsy)\n* Subjects taking medications that are considered prohibited\n\n  * Exception: Subjects taking any of the medications under \"Temporary medication adjustment required\" may participate if they are otherwise eligible AND the medication can be safely withheld (from immediately before the 1st study agent administration until at least 10 hours after the last study agent administration, for each dosing interval)\n* On herbal and natural medications with possible senolytic properties (i.e., curcumin, kava kava, St. John's wort) and are unable or unwilling to hold its administration 2 days prior to and during study treatment dosing. Exceptions include cannabidiol (CBD), vitamins, probiotics, and fish oil. Other herbal and natural medications may be permitted or prohibited per clinician discretion\n* Subjects taking potentially senolytic agents within the last year: fisetin, quercetin, luteolin, dasatinib or imatinib (or other tyrosine kinase inhibitors), piperlongumine, or navitoclax\n* Subjects on therapeutic doses of anticoagulants (e.g., warfarin, heparin, low molecular weight heparin, factor Xa inhibitors, etc.)\n* Issues with tolerating oral medication (such as but not limited to, inability to swallow pills (gastrostomy \\[g\\]-tubes not allowed), malabsorption issues, ongoing nausea or vomiting during screening, history of Crohn's, gastric bypass\u002Freduction, or celiac disease)\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Currently participating in another intervention research study seeking to improve functional status, alleviate frailty, muscle strength, exhaustion\u002Ffatigue, or cognitive function",{"count":277,"type":20},164,[24],"This phase II trial tests how well fisetin and exercise works in preventing frailty in breast cancer survivors. Fisetin is a natural substance found in strawberries and other foods and is available as a nutritional supplement. Nutritional supplements may be useful in eliminating cells that have undergone a process called senescence. Senescence is when a cell ages and permanently stops dividing but does not die. Over time, large numbers of these cells build up in tissues throughout the body and can release harmful substances that cause inflammation and damage nearby healthy cells. Giving fisetin may eliminate senescent cells in patients with breast cancer undergoing physical activity.",[281,84,85,282],"Anatomic Stage I Breast Cancer American Joint Committee on Cancer (AJCC) v8","Early Stage Breast Carcinoma","2026-07-28",{"date":285,"type":33},"2026-07-30",{"date":287,"type":33},"2024-07-23",{"date":289,"type":20},"2031-10-31",{"name":39,"class":40},6,{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":21,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":41},"100599834","phase-1-eras-801-for-the-treatment-of-resectable-and-progressive-or-recurrent-or-elderly-newly-diagnosed-idh-wildtype-grade-iv-glioblastoma-or-gliosarcoma-with-an-egfr-amplification-or-mutation-eras801-sarg-trial-100599834","NCT07089641","ERAS-801 for the Treatment of Resectable and Progressive or Recurrent or Elderly Newly Diagnosed IDH Wildtype Grade IV Glioblastoma or Gliosarcoma With an EGFR Amplification or Mutation, ERAS801-SARG Trial","A Phase Ib Open Label Clinical Trial to Evaluate the Safety and Efficacy of ERAS-801 in Recurrent Glioblastoma or Elderly Newly Diagnosed Glioblastoma Patients With EGFR Amplification and\u002For Mutation (ERAS-801-3.0)","Inclusion Criteria:\n\n* COHORT A: Patients must be 18 years of age or older on the day of signing informed consent\n* COHORT A: Patients must have histologically proven surgically accessible World Health Organization (WHO) grade IV glioblastoma\u002Fgliosarcoma, which is progressive or recurrent following radiation therapy +\u002F- chemotherapy\n* COHORT A: Patient tumor sample must have wild type IDH with evidence of EGFR mutation\u002Famplification by Clinical Laboratory Improvement Act (CLIA)-certified laboratory assay. Patients with EGFR mutations in T790M or exon 20 will be excluded\n* COHORT A: Patients may have had no more than two prior recurrences\n* COHORT A: Patient must be able to tolerate MRIs. Pre-study enrollment MRIs must be available for central review, including at least the immediate pre-progression scan and the scan demonstrating progression. Patients must have measurable, by RANO, supratentorial contrast-enhancing progressive or recurrent high-grade glioma by MRI imaging within 28 days prior to enrollment\n* COHORT A: Patients must have recovered from severe toxicity of prior therapy. The following intervals from previous treatments are required to be eligible:\n\n  * 12 weeks from the completion of radiation\n  * 6 weeks from a nitrosourea chemotherapy\n  * 3 weeks from a non-nitrosourea chemotherapy\n  * 4 weeks from any investigational (not Food and Drug Administration \\[FDA\\]-approved) agents\n  * 4 weeks from the last treatment with bevacizumab\n  * 2 weeks from administration of a non-cytotoxic, FDA-approved agent other than bevacizumab (e.g., hydroxychloroquine, etc.)\n  * 1 week from the tumor treating fields\n* COHORT A: Patients must be undergoing surgery that is clinically indicated as determined by their care providers. Patients must be eligible for surgical resection according to the following criteria:\n\n  * Expectation that the surgeon can resect at least 500 mg of tumor from enhancing tumor and 100 mg from non-enhancing tumor (if available) with low risk of inducing neurological injury\n* COHORT A: Paraffin embedded tissue must be available from initial surgical resection at diagnosis (prior to any treatment). The following amount of tissue is requested: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 30 FFPE unstained slides (5µm thick)\n* COHORT A: Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself\u002Fherself with occasional help from others)\n* COHORT A: Absolute neutrophil count (ANC) ≥ 1000\u002FuL\n* COHORT A: Platelets ≥ 100,000\u002FuL\n* COHORT A: Hemoglobin ≥ 9.0 g\u002FdL or ≥ 5.6 mmol\u002FL\n\n  * Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\n* COHORT A: Creatinine ≤ 1 x upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 30 mL\u002Fmin for participant with creatinine levels \\> 1 x institutional ULN (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or creatinine clearance \\[CrCl\\])\n\n  * Creatinine clearance (CrCl) should be calculated per institutional standard\n* COHORT A: Total bilirubin ≤ 1.5 x ULN unless with Gilbert's syndrome\n* COHORT A: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x ULN\n* COHORT A: International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* COHORT A: Patients must have left ventricular ejection fraction (LVEF) within normal institutional limits within 21 days of starting treatment\n* COHORT A: Patients must have a 12-lead electrocardiogram performed within 2 weeks of treatment start with Fridericia's formula-corrected QT interval (QTcF) =\\\u003C 450 msec\n* COHORT A: Patients must be able to provide written informed consent\n* COHORT A: Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose\n* COHORT A: Women of childbearing potential and men must agree to use adequate method of contraception for the duration of study participation and for at least 6 months after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 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 for 6 months after the last dose of study drug\n* COHORT A: Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, prostate, bladder or melanoma in situ. Patients with prior malignancies must be disease-free for \\> three years\n* COHORT A: Patients must be able to swallow medication by mouth\n* COHORT B: Patients must be 18 years of age or older on the day of signing informed consent\n* COHORT B: Patients must have histologically proven WHO grade 4 glioblastoma\u002Fgliosarcoma, which is progressive or recurrent following radiation therapy +\u002F- chemotherapy\n* COHORT B: Patient initial tumor sample must have wild type IDH with evidence of EGFR mutation\u002Famplification by CLIA-certified laboratory assay. Patients with EGFR mutations in T790M or exon 20 will be excluded\n* COHORT B: Patients may have had no more than two prior recurrences\n* COHORT B: Patient must be able to tolerate MRIs. Pre-study enrollment MRIs must be available for central review, including at least the immediate pre-progression scan and the scan demonstrating progression. Patients must have measurable, by RANO, supratentorial contrast-enhancing progressive or recurrent high-grade glioma by MRI imaging within 14 days prior to enrollment\n* COHORT B: Patients must have recovered from severe toxicity of prior therapy. The following intervals from previous treatments are required to be eligible:\n\n  * 12 weeks from the completion of radiation\n  * 6 weeks from a nitrosourea chemotherapy\n  * 3 weeks from a non-nitrosourea chemotherapy\n  * 4 weeks from any investigational (not FDA-approved) agents\n  * 4 weeks from the last treatment with bevacizumab\n  * 2 weeks from administration of an anti-cancer, non-cytotoxic, FDA-approved agent other than bevacizumab (e.g., hydroxychloroquine, etc.)\n  * 1 week from the tumor treating fields device(s)\n* COHORT B: Paraffin embedded tissue must be available from initial surgical resection at diagnosis. The following amount of tissue is requested: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 30 FFPE unstained slides (5um thick).\n* COHORT B: Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself\u002Fherself with occasional help from others)\n* COHORT B: Absolute neutrophil count (ANC) ≥ 1000\u002FuL\n* COHORT B: Platelets ≥ 100000\u002FuL\n* COHORT B: Hemoglobin ≥ 9.0 g\u002FdL or ≥ 5.6 mmol\u002FLa\n\n  * Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\n* COHORT B: Creatinine \\\u003C 1.5 times ULN or measured or calculated creatinine clearance \\> 30 mL\u002Fmin for participant with creatinine levels \\> 1.5 x institutional ULN (GFR can also be used in place of creatinine or CrCl)\n\n  * Creatinine clearance (CrCl) should be calculated per institutional standard.\n* COHORT B: Total bilirubin ≤ 1.5 x ULN unless with Gilbert's syndrome\n* COHORT B: AST (SGOT) and ALT (SGPT) ≤ 3 x ULN\n* COHORT B: International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) ) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* COHORT B: Patients must have left ventricular ejection fraction (LVEF) within normal institutional limits within 21 days of starting treatment\n* COHORT B: Patients must have a 12-lead electrocardiogram performed within 2 weeks of treatment start with QTcF ≤ 450 msec\n* COHORT B: Patients must be able to provide written informed consent\n* COHORT B: Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose\n* COHORT B: Women of childbearing potential and men must agree to use adequate method of contraception for the duration of study participation and for at least 6 months after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 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 for 6 months after the last dose of study drug\n* COHORT B: Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, prostate, bladder or melanoma in situ. Patients with prior malignancies must be disease-free for \\> three years\n* COHORT B: Patients must be able to swallow medication by mouth\n* COHORT C: Patients must be ≥ 70 years of age at the time of informed consent, with a life expectancy \\> 8 weeks\n* COHORT C: Patients must have histologically proven newly diagnosed WHO grade 4 glioblastoma\u002Fgliosarcoma\n* COHORT C: Patient initial tumor sample must have wild type IDH with evidence of EGFR mutation\u002Famplification by CLIA-certified laboratory assay. Patients with EGFR mutations in T790M or exon 20 will be excluded\n* COHORT C: Patient must be able to tolerate MRIs. Pre-study enrollment MRIs must be available for central review, including the pre-surgery MRI and the immediate post-diagnostic surgery MRI. The immediate postoperative MRI is preferred but not required to occur within 96 hours of surgery. The patient must also have a baseline MRI within 14 days prior to enrollment. Craniotomy or intracranial biopsy site must be adequately healed and free of drainage or cellulitis. Enrollment is at least 2-4 weeks from prior surgery (if time is needed to be extended, PI approval needed)\n* COHORT C: Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself\u002Fherself with occasional help from others)\n* COHORT C: Absolute neutrophil count (ANC) ≥ 1000\u002FuL\n* COHORT C: Platelets ≥ 100000\u002FuL\n* COHORT C: Hemoglobin ≥ 9.0 g\u002FdL or ≥ 5.6 mmol\u002FLa\n\n  * Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\n* COHORT C: Creatinine \\\u003C 1.5 times ULN OR measured or calculated creatinine clearance \\> 30 mL\u002Fmin for participant with creatinine levels \\> 1.5 x institutional ULN (GFR can also be used in place of creatinine or CrCl)\n\n  * Creatinine clearance (CrCl) should be calculated per institutional standard\n* COHORT C: Total bilirubin ≤ 1.5 x ULN unless with Gilbert's syndrome\n* COHORT C: AST (SGOT) and ALT (SGPT) ≤ 3 x ULN\n* COHORT C: International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* COHORT C: Paraffin embedded tissue must be available from initial surgical resection at diagnosis. The following amount of tissue is requested: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 30 FFPE unstained slides (5um thick)\n* COHORT C: Patients must have left ventricular ejection fraction (LVEF) within normal institutional limits within 21 days of starting treatment\n* COHORT C: Patients must have a 12-lead electrocardiogram performed within 2 weeks of treatment start with QTcF ≤ 450 msec\n* COHORT C: Patients must be able to provide written informed consent\n* COHORT C: Men treated or enrolled on this protocol who has a partner with reproductive potential must agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after the last dose of study drug\n* COHORT C: Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, prostate, bladder or melanoma in situ. Patients with prior malignancies must be disease-free for \\> three years\n* COHORT C: Patients must be able to swallow medication by mouth\n\nExclusion Criteria:\n\n* COHORT A: Participants may not be receiving any other investigational agents\n* COHORT A: Participants with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ERAS-801 are ineligible\n* COHORT A: Participants with prior therapy with EGFR inhibitors such as EGFR kinase inhibitors or other EGFR-targeted agents that have the potential to deplete the tumor of EGFR-amplified or EGFR mutant cell populations and confound the evaluation of ERAS-801 effects on participants are ineligible. If a participant had received previous treatment with EGFR-targeted agents but tumor resection after completing this treatment still shows EGFR amplification, patient might still be eligible and should be discussed with the principal investigator (PI)\n* COHORT A: Participants on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol. Patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs. Patients previously treated with EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to the first dose of ERAS-801\n* COHORT A: Participants must not have evidence of significant hematologic, renal, or hepatic dysfunction\n* COHORT A: Participants must not have evidence of significant intracranial hemorrhage\n* COHORT A: Participants with clinically significant cardiovascular disease including, but not limited to:\n\n  * Myocardial infarction or unstable angina within the 6 months prior to the first dose of study drug\n  * Clinically significant cardiac arrhythmia\n  * Prolonged QTcF \\> 450 ms\n  * Uncontrolled (persistent) hypertension: systolic blood pressure \\> 180 mmHg; diastolic blood pressure \\> 100 mmHg\n  * Congestive heart failure (New York Heart Association class III-IV)\n  * Use of pacemaker\n  * Pulmonary embolism \\\u003C 30 days\n* COHORT A: Participants with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, are ineligible\n* COHORT A: Pregnant women are excluded from this study because ERAS-801 has unknown potential for teratogenic or abortifacients effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ERAS-801, breastfeeding should be discontinued if the mother is treated with ERAS-801\n* COHORT A: Participants currently using or anticipating need to use drugs, food, or herbal supplements known to be strong or moderate inducers or inhibitors of CYP3A4, CYP2C8, and\u002For CYP2D6 and P-glycoprotein (P-gp) substrates may be enrolled if they have been off the substrates for at least 10 days or 5 half-lives prior to the first dose of ERAS 801, whichever is shorter\n* COHORT A: Participants who have acute or currently active\u002Frequiring anti-viral therapy hepatic or biliary disease are ineligible (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases from the primary brain tumor, or stable chronic liver disease per investigator assessment)\n* COHORT A: Patients with gastrointestinal conditions that may affect reliable administration\u002Fabsorption of medications including difficulty swallowing\u002Funable to swallow pills; malabsorption syndrome; refractory nausea and vomiting, chronic gastrointestinal (GI) disease or previous significant bowel resection with clinically significant sequelae are ineligible\n* COHORT A: Participants receiving P-gp inhibitors are ineligible\n* COHORT A: Patients who have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial are ineligible\n* COHORT B: Participants may not be receiving any other investigational agents\n* COHORT B: Participants with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ERAS-801 are ineligible\n* COHORT B: Participants with prior therapy with EGFR inhibitors such as EGFR kinase inhibitors or other EGFR-targeted agents that have the potential to deplete the tumor of EGFR-amplified or EGFR mutant cell populations and confound the evaluation of ERAS-801 effects on participants are ineligible. If a participant had received previous treatment with EGFR-targeted agents but tumor resection after completing this treatment still shows EGFR amplification, patient might still be eligible and should be discussed with the PI\n* COHORT B: Participants on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol. Patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs. Patients previously treated with EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to the first dose of ERAS-801\n* COHORT B: Participants must not have evidence of significant hematologic, renal, or hepatic dysfunction\n* COHORT B: Participants must not have evidence of significant intracranial hemorrhage\n* COHORT B: Participants with clinically significant cardiovascular disease including, but not limited to:\n\n  * Myocardial infarction or unstable angina within the 6 months prior to the first dose of study drug\n  * Clinically significant cardiac arrhythmia\n  * Prolonged QTcF\\> 450 ms\n  * Uncontrolled (persistent) hypertension: systolic blood pressure \\> 180 mmHg; diastolic blood pressure \\> 100 mmHg\n  * Congestive heart failure (New York Heart Association class III-IV)\n  * Use of pacemaker\n  * Pulmonary embolism \\\u003C 30 days\n* COHORT B: Participants with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, are ineligible\n* COHORT B: Pregnant women are excluded from this study because ERAS-801 has unknown potential for teratogenic or abortifacients effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ERAS-801, breastfeeding should be discontinued if the mother is treated with ERAS-801\n* COHORT B: Participants currently using or anticipating need to use drugs, food, or herbal supplements known to be strong or moderate inducers or inhibitors of CYP3A4, CYP2C8, and\u002For CYP2D6 and P-gp substrates may be enrolled if they have been off the substrates for at least 10 days or 5 half-lives prior to the first dose of ERAS 801, whichever is shorter\n* COHORT B: Participants who have acute or currently active\u002Frequiring anti-viral therapy hepatic or biliary disease are ineligible (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases from the primary brain tumor, or stable chronic liver disease per investigator assessment)\n* COHORT B: Patients with gastrointestinal conditions that may affect reliable administration\u002Fabsorption of medications including difficulty swallowing\u002Funable to swallow pills; malabsorption syndrome; refractory nausea and vomiting, chronic gastrointestinal (G",{"count":300,"type":20},50,[23],"This phase Ib trial tests the safety and side effects of ERAS-801 in treating patients with isocitrate dehydrogenase (IDH) wildtype, epidermal growth factor receptor (EGFR) amplified or mutated grade IV glioblastoma or gliosarcoma that can be removed by surgery (resectable) and that is growing, spreading, or getting worse (progressive), that has come back after a period of improvement (recurrent) or that is newly diagnosed in an elderly patient. Glioblastoma is the most common brain cancer in adults and survival rates remain poor despite treatment including surgery, radiation and chemotherapy. EGFR is a protein found on the surface of some cells, to which epidermal growth factor binds, causing the cells to divide. It is found at abnormally high levels on the surface of many types of tumor cells, so these cells may divide excessively in the presence of epidermal growth factor. ERAS-801, an EGFR inhibitor that can penetrate the central nervous system, binds to the tumor cells that express EGFR and may help shrink or slow the growth of the tumor cells.",[304,305,306,307,308,309],"Glioblastoma","Glioblastoma, IDH-Wildtype","Gliosarcoma","Recurrent Glioblastoma, IDH-Wildtype","Recurrent Gliosarcoma","Resectable Glioblastoma","2026-07-16",{"date":312,"type":33},"2026-07-20",{"date":314,"type":33},"2025-07-28",{"date":316,"type":20},"2028-07-30",{"name":39,"class":40},{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":21,"phases":327,"briefSummary":328,"conditions":329,"keywords":332,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":70},"100578398","phase-1-duvelisib-and-venetoclax-in-patients-with-relapsed-or-refractory-peripheral-t-cell-lymphoma-ptcl-100578398","NCT06810778","Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)","Phase I\u002FII Study of Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)","Inclusion Criteria:\n\n* Phase I: Histologically confirmed relapsed\u002Frefractory PTCL, except the following lymphoma subtypes: cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL).\n* Phase II: same as phase I\n* Disease that has progressed during or relapsed after at least two previous therapies.\n* ECOG performance status ≤ 2\n* Adequate hepatic function defined as:\n\n  o Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN), bilirubin ≤ 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin\n* Adequate renal function as defined by:\n\n  o Creatinine clearance ≥ 30 mL\u002Fmin; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection\n* Patients must meet the following hematologic criteria at screening, unless they have significant bone marrow involvement confirmed on biopsy:\n\n  * Absolute neutrophil count ≥ 1500 cells\u002Fmm3 (1.5 x 109\u002FL) or ≥ 1000 cells\u002Fmm3 (1.5 x 109\u002FL) with bone marrow involvement. Growth factor use is allowed in order to achieve this\n  * Platelet count ≥ 50,000 cells\u002Fmm3 (50 x 109\u002FL) independent of transfusion within 7 days of screening\n  * Hemoglobin ≥8 g\u002FdL (without transfusion support.)\n\nExclusion Criteria:\n\n* Phase I and Phase II:\n\n  * Patients eligible for Hematopoietic stem cell transplantation (HSCT)\n  * Cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL)\n  * Suspected and confirmed central nervous system involvement\n  * Previous treatment with venetoclax or a PI3K inhibitor.\n  * Active malignancy other than NHL requiring ongoing therapy, with the exception of hormonal therapy (i.e. castration-sensitive prostate cancer stable on testosterone blockade)\n  * Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, surgery) within 2 weeks of Cycle 1\u002FDay 1 with the following exceptions:\n\n    * For patients on targeted therapies, a washout of least five half-lives is required\n    * Patients who experience clinical deterioration may start therapy after a shorter washout period with prior approval by the PI\n    * Corticosteroid therapy (prednisone or equivalent \\\u003C20 mg daily) is allowed\n    * Patients with multiple basal cell carcinomas that undergo sequential Moh's excisions with interim observation\n  * Allogeneic hematologic stem cell transplant within 6 months of starting study treatment or active graft vs. host disease (GVHD) requiring treatment or prophylaxis\n\n    o Patients with a history of an allogeneic stem cell transplant \\> 6 months prior to starting study treatment should be stable, off of immunosuppression for at least 2 months.\n  * Any active systemic infection requiring systemic antibiotics or other uncontrolled, active infections\n  * Positive Human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) antibody test\n\n    o For HCV and HBV, patients with evidence of prior infection also excluded\n  * Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n    * Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal)\n    * Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: 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\n  * Uncontrolled, not disease-related autoimmune hemolytic anemia or ITP\n  * History of stroke or intracranial hemorrhage\n  * History of severe bleeding disorder (hemophilia A or B, von Willebrand disease (VWD)), history of spontaneous bleeding requiring blood transfusions or other medical intervention, history of life-threatening hemorrhage within 3 months of first dose.\n  * Currently active gastrointestinal disease, including colitis, inflammatory bowel disease and diarrhea requiring therapy\n  * Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment\n  * Cardiac history of CHF requiring treatment or Ejection Fraction ≤ 50% or chronic stable angina\n  * Use of Coumadin for anticoagulation (other anticoagulants permitted)\n  * Lactating or pregnant\n  * Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction resulting in malabsorption or chronic diarrhea\n  * Concurrent administration of medications or foods that are strong inhibitors or inducers of CYP3A (see Appendix D)\n  * Treatment with any of the following within 7 days prior to the first dose of study drug:\n  * Steroid therapy for anti-neoplastic intent (defined as prednisone or equivalent \\>20 mg daily)\n  * Moderate or strong cytochrome P450 3A (CYP3A) inhibitors (see Appendix D for examples)\n  * Moderate or strong CYP3A inducers (see Appendix D for examples)\n  * Administration or consumption of any of the following within 7 days prior to the first dose of study drug:\n\n    * Grapefruit or grapefruit products\n    * Seville oranges (including marmalade containing Seville oranges)\n    * Star fruit",{"count":326,"type":20},12,[23,24],"This is an open-label, phase I\u002FII study of duvelisib in combination with Venetoclax for patients with relapsed\u002Frefractory NHL. Duvelisib is an FDA approved, marketed product used to treat certain patients with leukemia and lymphoma and Venetoclax, which is approved for treatment of certain patients with acute myeloid leukemia. The combination of these two drugs is experimental. Experimental means that it is not approved by the United States Food and Drug Administration (FDA). The researchers want to find out how safe it is to combine these drugs and how well this combination can work for your cancer.",[330,331],"T-cell-prolymphocytic Leukemia","Cutaneous T-Cell Lymphoma Refractory",[333,334,335],"leukemia","refractory","relapsed",{"date":337,"type":33},"2026-07-17",{"date":339,"type":33},"2025-05-02",{"date":341,"type":20},"2031-06-01",{"name":39,"class":40},{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":103,"minAge":18,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":21,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":70},"100521259","phase-2-hormone-therapy-apalutamide-and-image-guided-stereotactic-body-radiation-therapy-for-the-treatment-of-patients-with-prostate-cancer-heatwave-trial-100521259","NCT06067269","Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial","High Precision Stereotactic Radiotherapy to the Whole Prostate With Focal Boost and Varying Hormonal Therapy (HEATWAVE)","HEATWAVE","Inclusion Criteria:\n\n* Confirmed diagnosis of prostate adenocarcinoma\n* Age ≥ 18\n* Classified as having National Comprehensive Cancer Network unfavorable intermediate risk prostate cancer (i.e., \\[a\\] 2 of the following: PSA 10-20 ng\u002FmL, clinical T category 2b-2c, or International Society of Urological Pathology \\[ISUP\\] grade group 2; \\[b\\] OR any 1 of \\[a\\] with ISUP grade group 3 disease; OR \\[c\\] any 1 of \\[a\\] with 50% or more cores on systematic biopsy showing prostate cancer)\n* Have a Decipher genomic classifier score\n* Have at least one dominant intraprostatic lesion visible on multiparametric MRI (Prostate Imaging-Reporting and Data System \\[PI-RADS\\] version 2.1 score 4 or 5)\n* Have underwent a prostate specific membrane antigen (PSMA) positron emission tomography\u002Fcomputed tomography (PET\u002FCT)\n* Have total testosterone \\>= 150 ng\u002FdL\n* Adequate performance status (Eastern Cooperative Oncology Group \\[ECOG\\] 0-1)\n* Hemoglobin ≥ 9.0 g\u002FdL, independent of transfusion and\u002For growth factors within 3 months prior to randomization (at screening)\n* Platelet count ≥ 100,000 x 10\\^9\u002FuL independent of transfusion and\u002For growth factors within 3 months prior to randomization (at screening)\n* Serum albumin ≥ 3.0 g\u002FdL (at screening)\n* Glomerular filtration rate (GFR) ≥ 45 mL\u002Fmin (at screening)\n* Serum potassium ≥ 3.5 mmol\u002FL (at screening)\n* Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \\> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible) (at screening)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\\u003C 2.5 x ULN (at screening)\n* Medications known to lower the seizure threshold (see list under prohibited medications) must be discontinued or substituted at least 4 weeks prior to study entry\n\nExclusion Criteria:\n\n* Any evidence of spinal cord compression (radiological or clinical)\n* Prior pelvic malignancy\n* Prior pelvic radiation\n* Concurrent malignancy other than adequately treated basal cell or squamous cell skin cancer, non-muscle invasive bladder cancer (NMIBC), or any other cancer in situ currently without evidence of recurrence or progression\n* Inability to undergo radiotherapy, or hormonal therapy\n* Primary small cell carcinoma of the prostate (prostate adenocarcinoma with neuroendocrine differentiation is allowed)\n* Inflammatory bowel disease or active collagen vascular disease\n* History of any of the following:\n\n  * Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \\[CNS\\] or meningeal disease which may require treatment with surgery or radiation therapy)\n  * Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization\n* Current evidence of any of the following:\n\n  * Uncontrolled hypertension\n  * Gastrointestinal disorder affecting absorption\n  * Known active infection (eg, human immunodeficiency virus \\[HIV\\] or viral hepatitis)\n  * Any condition that in the opinion of the investigator would preclude participation in this study\n  * Treatment with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, a dose reduction of the CYP2D6 substrate may be considered\n  * Baseline moderate and severe hepatic impairment (Child Pugh class B \\& C)",{"count":352,"type":20},95,[24],"This phase II trial evaluates apalutamide in combination with image-guided stereotactic body radiation therapy (SBRT) for the treatment of patients with prostate cancer. Prostate cancer usually needs the hormone testosterone to grow. Apalutamide is a hormone therapy that blocks the effect of testosterone on prostate tumor cells. This may help stop the growth of tumor cells that need testosterone to grow. Image-guided SBRT is a standard treatment for some types of prostate cancer. This treatment combines imaging of cancer within the body, with the delivery of therapeutic radiation doses produced on a linear accelerator machine. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Combining apalutamide with image-guided SBRT may increase a prostate cancer patient's chances of achieving an extremely low prostate specific antigen response, which is an early predictor of disease cure.",[178,356,182,183],"Stage II Prostate Cancer AJCC v8",{"date":337,"type":33},{"date":359,"type":33},"2024-03-28",{"date":361,"type":20},"2027-12-30",{"name":39,"class":40},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":127,"minAge":4,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":21,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":381},"100485010","phase-2-fisetin-to-improve-physical-function-in-stage-i-iii-breast-cancer-survivors-100485010","NCT05595499","Fisetin to Improve Physical Function in Stage I-III Breast Cancer Survivors","A Phase II Randomized Double-Blind Placebo-Controlled Study of Fisetin to Improve Physical Function in Breast Cancer Survivors","Inclusion Criteria:\n\n* Women who are postmenopausal at the start of study treatment.\n\nPostmenopausal status will be established as follows:\n\n* Women aged: \\>= 60 years OR\n* Women aged \\\u003C 60 years AND one of the following conditions is met:\n\n  * They have not had any menstrual periods for at least 12 months in the absence of exogenous hormonal treatments, chemotherapy, and\u002For tamoxifen AND have serum estradiol and follicle-stimulating hormone (FSH) levels confirmed as being within the standard laboratory reference range for postmenopausal females.\n  * They have documented irreversible bilateral oophorectomy.\n  * They are receiving ovarian suppression with their breast cancer endocrine therapy\n\n    * Women with a diagnosis of early-stage breast cancer (Stage I-III) treated with neo\u002Fadjuvant chemotherapy within 12 months of starting study treatment\n    * No evidence of active\u002Frecurrent breast cancer or other serious chronic illnesses\n    * Have evidence of frail health, defined as a diminished 6-minute walk distance (\\\u003C 400m) at baseline\n    * Platelets \\> 60,000\u002Fmm\\^3\n    * White blood cell count \\> 2,000\u002Fmm\\^3\n    * Absolute neutrophil count \\> 500\u002Fmm\\^3\n    * Hemoglobin \\>= 8.0 g\u002FdL\n    * Total bilirubin =\\\u003C 3.0 X upper limit of normal (ULN)\n    * Aspartate aminotransferase (AST) =\\\u003C 4.0 x ULN\n    * Alanine aminotransferase (ALT) =\\\u003C 4.0 x ULN\n    * Estimated glomerular filtration rate (eGFR) of \\>= 30mL\u002Fmin\u002F1.73m\\^2 per the Modification of Diet in Renal Disease (MDRD) calculation\n    * Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Cancer-directed chemotherapy, biological therapy, or immunotherapy within 30 days prior to the start of study treatment. Exceptions include: trastuzumab, pertuzumab, pembrolizumab, tamoxifen, ribociclib, abemaciclib, aromatase inhibitors and\u002For ovarian suppression.\n* Surgery and\u002For radiation within the last 30 days of starting study treatment (Exception: invasive non- major procedures such as an outpatient biopsy)\n* Subjects taking medications that are considered prohibited.\n\n  * Exception: Subjects taking any of the medications listed in under \"Temporary medication adjustment required\" may participate if they are otherwise eligible AND the medication can be safely withheld (from immediately before the 1st study agent administration until at least 10 hours after the last study agent administration, for each dosing interval)\n* On herbal and natural medications with possible senolytic properties (i.e., curcumin, kava kava, St. John's wort) and are unable or unwilling to hold its administration 2 days prior to and during study treatment dosing. Exceptions include cannabidiol (CBD), vitamins, probiotics, and fish oil. Other herbal and natural medications may be permitted or prohibited per clinician discretion\n* Subjects taking potentially senolytic agents within the last year: fisetin, quercetin, luteolin, dasatinib or imatinib (or other tyrosine kinase inhibitors), piperlongumine, or navitoclax\n* Subjects on therapeutic doses of anticoagulants (e.g., warfarin, heparin, low molecular weight heparin, factor Xa inhibitors, etc.)\n* Issues with tolerating oral medication (such as but not limited to, inability to swallow pills (g-tubes not allowed), malabsorption issues, ongoing nausea or vomiting during screening, history of Crohn's, gastric bypass\u002Freduction, or celiac disease)\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Currently participating in another intervention research study seeking to improve functional status, alleviate frailty, muscle strength, exhaustion\u002Ffatigue, or cognitive function",{"count":371,"type":20},88,[24],"This phase II trial tests whether fisetin works to improve physical function in women who have received chemotherapy for stage I-III breast cancer treatment. Fisetin is a naturally occurring substance that is found in strawberries and other foods. Fisetin eliminates cells that have undergone a process called senescence. Senescence is when a cell ages and permanently stops dividing but does not die. Over time, large numbers of these cells build up in tissues throughout the body and can release harmful substances that causes inflammation and damages nearby healthy cells. Studies have shown that chemotherapy causes a build-up of these senescent cells. Giving fisetin may eliminate senescent cells and improve physical function in postmenopausal women who have received chemotherapy for breast cancer.",[83,84,85],{"date":337,"type":33},{"date":377,"type":33},"2023-03-27",{"date":379,"type":20},"2028-08-14",{"name":39,"class":40},7,{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":103,"minAge":4,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":21,"phases":391,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":401,"locationsCount":70},"100428320","early-phase-1-99mtc-psma-is-biodistribution-in-patients-with-prostate-cancer-100428320","NCT04857502","99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer","99mTc-PSMA-I&Amp;S in Patients With Prostate Cancer: An Exploratory Biodistribution Study With Histopathology Validation","Inclusion Criteria:\n\n* Men with PCa (primary or recurrent disease)\n* Men who received a 68Ga-PSMA-11 positron emission tomography (PET)\u002Fcomputed tomography (CT) for staging or restaging\n* Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET\u002FCT\n* Men who are scheduled for pelvic LN dissection (PLND)\n* Men who can provide oral and written informed consent\n* Men who can comply with study procedures\n\nExclusion Criteria:\n\n* Patients who started any PCa treatment between study enrollment and surgery\n* Technically inaccessible nodal location",{"count":390,"type":20},30,[392],"EARLY_PHASE1","This exploratory study conducted under the RDRC program studies the biodistribution of 99mTc-PSMA-I\\&S in patients with prostate cancer who undergo pelvic lymph node dissection. Prostate specific membrane antigen (PSMA)-targeted radio-guided surgery uses the preoperative intravenous administration of a PSMA-ligand called PSMA-imaging and surgery (I\\&S) labeled with the gamma-emitter radioisotope Technetium-99m (99mTc). Giving 99mTc-PSMA-I\\&S may detect PSMA-expressing lymph nodes during surgery using a gamma probe and may help guide doctors to detect prostate cancer that has spread to the lymph nodes.",[395,396],"Prostate Carcinoma","Recurrent Prostate Carcinoma",{"date":337,"type":33},{"date":399,"type":33},"2021-04-27",{"date":68,"type":20},{"name":39,"class":40},{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":127,"minAge":4,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":21,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":422,"locationsCount":70},"100398563","phase-2-abemaciclib-for-the-treatment-of-recurrent-ovarian-or-endometrial-cancer-100398563","NCT04469764","Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer","An Open Label Phase II Study of the Efficacy and Safety of Abemaciclib, a Cyclin Dependent Kinase (CDK4\u002F6) Inhibitor in Selected Patients With Recurrent Ovarian or Endometrial Cancer","Inclusion Criteria:\n\n* Histologically-confirmed ovarian epithelial (including fallopian tube and primary peritoneal) cancer or endometrial cancer\n* Molecular tumor board confirms that patient's archival ovarian cancer tumor specimen has been assessed using standard of care genomic profiling and demonstrates CDK4\u002F6 activation features\n* Molecular tumor board confirms that patient's archival endometrial cancer tumor specimen has been assessed using standard of care genomic profiling and is of endometrioid histology, has positive hormone receptor expression and lack of Cyclin E gene (CCNE) amplification or retinoblastoma susceptibility gene product (RB) loss\n* At least one prior chemotherapy regimen for the treatment of recurrent ovarian or endometrial cancer\n* Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] grade =\\\u003C 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy prior to enrollment. A washout period of at least 21 days is required between last chemotherapy dose and study initiation\n* Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and study initiation\n* The patient is able to swallow oral medications\n* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures\n* Informed consent must be obtained in writing for all patients prior to performing study\u002Fscreening procedures and prior to registration into the study\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL\n* Platelets \\>= 100 x 10\\^9\u002FL\n* Hemoglobin \\>= 8 g\u002FdL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN). Patients with Gilbert's syndrome with a total bilirubin =\\\u003C 2.0 times ULN and direct bilirubin within normal limits are permitted\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 3 x ULN\n* Female participants of childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of abemaciclib and agree to use a highly effective contraception method during the treatment period and for 3 weeks following the last dose of abemaciclib\n\nExclusion Criteria:\n\n* Anticipation of immediate need for a major surgical procedure (e.g., impending bowel obstruction, gastrointestinal perforation) or radiation therapy during the trial\n* Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri or breast\n* Treatment with chemotherapy, surgery, blood products, or an investigational agent within 3 weeks of trial enrollment\n* Any of the following within 6 months prior to trial registration: myocardial infarction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism\n* Unstable brain metastases or carcinomatous meningitis\n* Patient of child-bearing potential is evidently pregnant or is breast feeding. A woman with child bearing potential is defined as not surgically sterile or being post-menopausal for less than 6 months\n* Patient of child-bearing potential is not willing to use adequate contraceptive precautions. Adequate effective method of contraception are those which result in low failure rates, less than 1% per year, such as non-hormonal intrauterine device (IUD), condoms, sexual abstinence or vasectomized partner\n* The patient has serious preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea)\n* The patient has active bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]. Screening is not required for enrollment\n* The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n* Current use or anticipated need for: Food or drugs that are known strong CYP3A4 inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, tilithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delaviridine)\n* Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of trial results, and in the judgment of the investigator would make the patient inappropriate for entry into this trial",{"count":410,"type":20},32,[24],"This phase II trial studies how well abemaciclib works in treating patients with ovarian or endometrial cancer that has an activation of the CDK4\u002F6 pathway and that has come back (recurrent). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving abemaciclib may work better for the treatment of recurrent ovarian and endometrial cancer.",[414,415,416,417],"Recurrent Endometrial Carcinoma","Recurrent Fallopian Tube Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma",{"date":337,"type":33},{"date":420,"type":33},"2020-10-16",{"date":163,"type":20},{"name":39,"class":40},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":430,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":21,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":259,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":70},"100647851","phase-1-epcoritamab-and-pola-r-mini-chp-for-the-treatment-of-diffuse-large-b-cell-lymphoma-in-elderly-or-unfit-patients-100647851","NCT07714421","Epcoritamab and Pola-R-mini-CHP for the Treatment of Diffuse Large B Cell Lymphoma in Elderly or Unfit Patients","A Phase I Study of Single Agent Epcoritamab Followed by Epcoritamab Plus Pola-R-Mini-CHP for Elderly\u002FUnfit Patients With Previously Untreated DLBCL","Inclusion Criteria:\n\n* Previously untreated, histologically confirmed DLBCL according to World Health Organization (WHO) 2016 classification\n\n  * Documented CD20+ mature B-cell neoplasm according to WHO classification (Swerdlow et al., 2016) or WHO classification (WHO, 2008) based on representative pathology report\n\n    * Diffuse large B-cell lymphoma note: Other double-\u002Ftriple-hit lymphomas are not eligible\n  * Untreated patients who transform from low grade marginal zone lymphoma (MZL)\n  * Other aggressive B-non-hodgkin lymphoma (NHL):\n\n    * Primary mediastinal (thymic) large B-cell lymphoma (PMBCL)\n    * High-grade B-cell lymphoma\n    * Newly diagnosed follicular lymphoma grade 3B (FL 3B)\n* At least one bi-dimensionally measurable nodal lesion, defined as \\> 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as \\> 1.0 cm in its longest diameter\n* Age \\> 80 years, or age 70-79 years and not considered a candidate for full-dose aggressive chemotherapy (R-CHOP) with at least one of the following:\n\n  * Impairment in \\> 2 activity of daily living (ADL) component and\u002For\n  * Impairment in \\> 2 instrumental activity of daily living (IADL) component and\u002For\n  * Cumulative Illness Rating Scale for Geriatrics (CIRS-G) score of at least 1 comorbidity with a severity score of 3-4 (not including lymphoma and hematologic deficiencies due to lymphoma) or a score of 2 in \\> 8 comorbidities.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Life expectancy of at least 24 weeks\n* No significant pulmonary comorbidities (e.g., history of pneumonitis, severe chronic obstructive pulmonary disease \\[COPD\\])\n* Left ventricular ejection fraction ≥ 45%\n* Creatinine clearance \\> 40 mL\u002Fmin\n\n  * Exceptions may be made for patients with creatinine clearance \\\u003C 40 mL\u002Fmin, provided creatinine is within normal range\n* Hemoglobin \\> 9 g\u002FdL\n* Absolute neutrophil counts ≥ 1.0 × 10\\^9\u002FL; growth factor support allowed in case of bone marrow involvement\n* Platelet counts ≥ 75 × 10\\^9\u002FL or, in the presence of bone marrow involvement or splenomegaly, ≥ 50 × 10\\^9\u002FL\n* Lymphocyte counts \\\u003C 5 × 10\\^9\u002FL\n* If receiving glucocorticoid treatment at screening, must be a maximum daily dose of prednisone 100 mg (or equivalent) and a total of no more than 140 mg over the last 14 days prior to the first dose of epcoritamab, unless for disease control\n* Before the first dose of epcoritamab, during the trial and for 12 months after last administration of epcoritamab, a woman must be either:\n\n  * Not of childbearing potential: premenarchal; postmenopausal (\\> 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone \\[FSH\\] level \\> 40 IU\u002FL or milli-International unit mIU\u002FmL); permanently sterilized (e.g., bilateral tubal occlusion \\[which includes tubal ligation procedures as consistent with local regulations\\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy\n* A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control (that is the use of condom) during the trial and for 12 months after receiving the last dose of epcoritamab\n* COVID-19 ELIGIBILITY CRITERIA: Subject has no known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection\n* COVID-19 ELIGIBILITY CRITERIA: If a subject has signs\u002Fsymptoms suggestive of SARS-CoV-2 infection or have had recent known exposure to someone with SARS-CoV-2 infection, the subject must have a negative molecular (e.g., polymerase chain reaction \\[PCR\\]) test, or 2 negative antigen test results at least 24 hours apart, to rule out SARS-CoV-2 infection.\n\n  * Note: SARS-CoV-2 diagnostic tests should be applied following local requirements\u002Frecommendations\n* COVID-19 ELIGIBILITY CRITERIA: Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen after they meet the following SARS-CoV-2 infection viral clearance criteria:\n\n  * No signs\u002Fsymptoms suggestive of active SARS-CoV-2 infection\n  * Negative molecular (e.g., PCR) result or 2 negative antigen test results at least 24 hours apart\n* COVID-19 ELIGIBILITY CRITERIA: Patients with SARS-CoV-2 antigen or PCR testing positivity within 30 days prior to cycle 1 day 1 are not eligible\n* COVID-19 ELIGIBILITY CRITERIA: Any patient with documented SARS-CoV-2 infection within 6 months prior to planned cycle 1 day 1 must have no persistent respiratory symptoms, no evidence of residual sequelae, and a negative PCR test for SARS-CoV-2\n* COVID-19 ELIGIBILITY CRITERIA: Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment) at the time of enrollment or within the previous 2 weeks prior to the first dose of epcoritamab, including COVID-19 infection. Note that a past COVID-19 infection may be a risk factor, but if resolved and the subject is vaccinated, it may be allowable to enroll the subject\n\nExclusion Criteria:\n\n* Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy\n\n  * Exception: patients who are treated with prednisone as part of pre-phase treatment\n* Current grade \\> 1 peripheral neuropathy by clinical examination\n* Known or suspected chronic active Epstein-Barr virus infection\n* Subjects that have transformed from indolent (i) NHL, who have previously been treated with an anthracycline-containing regimen or a CD3-CD20 bispecific antibody\n* Patients with known history or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening as confirmed by mandatory magnetic resonance imaging (MRI)\u002Fcomputed tomography (CT) scan (brain) and, if clinically indicated, by lumbar puncture\n* Aspartate aminotransferase (AST), and\u002For alanine aminotransferase (ALT) \\> 3 × upper limit of normal (within 14 days of initiation of study treatment)\n* Total bilirubin \\> 1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin (within 14 days of initiation of study treatment)\n\n  * Patients with a documented history of Gilbert syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible\n* International normalization ratio (INR) \\> 1.5 x upper limit of normal (ULN) in the absence of therapeutic anticoagulation (within 14 days of initiation of study treatment)\n* Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) \\> 1.5 x ULN in the absence of a lupus anticoagulant or therapeutic anticoagulant (within 14 days of initiation of study treatment)\n* Estimated creatinine clearance (CrCl) \\\u003C 40 mL\u002Fmin (within 14 days of initiation of study treatment)\n* Known clinically significant cardiovascular disease or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm) including:\n\n  * Unstable arrhythmias\n  * Onset of unstable angina pectoris within 6 months of signing informed consent form (ICF)\n  * Acute myocardial infarction within 6 months of signing ICF\n  * Congestive heart failure (New York Heart Association Class III or IV cardiac disease and\u002For known decrease ejection fraction of \\\u003C 45%)\n  * Stroke or intracranial hemorrhage within 6 months prior to signing ICF\n  * In case of any history of cardiovascular disease, a cardiology consult is required within 60 days of enrollment.\n  * For patients who are ≥ 75 years old, 2 or more active cardiovascular diseases (any type, ≥ grade 2)\n* Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy including, but not limited to, myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\n* Low-dose (≤ 10 mg\u002Fday) prednisolone (or equivalent) for rheumatoid arthritis or similar conditions is allowed\n* Received systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment \\\u003C 10 mg\u002Fday prednisone or equivalent within 2 weeks prior to first the dose of study drug\n* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology)\n\n  * Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus DNA is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated\n* Acute or chronic hepatitis C virus (HCV) infection\n\n  * Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction\n* Known human immunodeficiency virus (HIV) infection with a cluster of differentiation 4 (CD4) count greater than 200 cells\u002FµL; HIV testing is required at screening only if required per local health authorities or institutional standards\n* History of other malignancy that could affect compliance with the protocol or interpretation of results\n\n  * Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix, or early-stage localized prostate cancer (Gleason score \\\u003C 6 or below, Stage I or II) with no requirement for therapy at any time prior to study are eligible.\n  * Patients with a malignancy that has been treated with curative intent will also be excluded unless the malignancy has been in documented remission without treatment for \\> 2 years before enrollment. Exception will be made for patients with a history of breast cancer that is estrogen receptor-\u002Fprogesterone receptor-positive for more than 2 years before enrollment who are treated with adjuvant hormonal therapy\n* Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or that could increase risk to the patient\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks before cycle 1 day 1 (C1D1)\n* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Recent major surgery within 4 weeks before the start of C1D1\n* Superficial lymph node biopsies for diagnosis is allowed","70 Years",{"count":432,"type":20},20,[23],"This phase I trial tests the safety, side effects and best dose of epcoritamab alone and epcoritamab with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R- mini-CHP) for the treatment of diffuse large B cell lymphoma (DLBCL) in elderly or unfit patients. Epcoritamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a chemotherapy drug, called monomethyl auristatin E. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as B-cell receptors, and delivers monomethyl auristatin E to kill them. Rituximab is a monoclonal antibody. It binds to a protein called cluster of differentiation antigen 20 (CD20), which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Epcoritamab alone and epcoritamab with pola-R-mini-CHP may be safe, tolerable and\u002For effective in treating DLBCL in elderly or unfit patients.",[436,437,438,439,440],"Diffuse Large B-Cell Lymphoma","Grade 3b Follicular Lymphoma","High Grade B-Cell Lymphoma","Primary Mediastinal Large B-Cell Lymphoma","Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma","2026-07-15",{"date":312,"type":33},{"date":444,"type":20},"2026-12-08",{"date":446,"type":20},"2031-10-08",{"name":39,"class":40},{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":21,"phases":457,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":461,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":70},"100498839","phase-2-pembrolizumab-and-enfortumab-vedotin-with-pembrolizumab-prior-to-and-after-radical-nephroureterectomy-for-high-risk-upper-tract-urothelial-cancer-100498839","NCT05775471","Pembrolizumab and Enfortumab Vedotin With Pembrolizumab Prior to and After Radical Nephroureterectomy for High-Risk Upper Tract Urothelial Cancer","Neoadjuvant Combination Pembrolizumab \u002F Enfortumab Vedotin With Adjuvant Pembrolizumab Prior to and After Radical Nephroureterectomy for High-Risk Upper Tract Urothelial Carcinoma","Inclusion Criteria:\n\n* Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of high-risk upper tract urothelial carcinoma will be enrolled in this study\n* Male participants: A male participant must agree to use a contraception during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period\n* Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential (WOCBP) OR\n  * A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 6 months after the last dose of study treatment\n* Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention\n* Absolute neutrophil count (ANC) \\>= 1500\u002FuL (Specimens must be collected within 10 days prior to the start of study intervention)\n* Platelets \\>= 100000\u002FuL (Specimens must be collected within 10 days prior to the start of study intervention)\n* Hemoglobin \\>= 9.0 g\u002FdL or \\>= 5.6 mmol\u002FL (Specimens must be collected within 10 days prior to the start of study intervention)\n* Creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance \\[CrCl\\]) (Specimens must be collected within 10 days prior to the start of study intervention) \\>= 30 mL\u002Fmin for participant with creatinine levels \\> 1.5 x institutional ULN\n* Total bilirubin =\\\u003C1.5 ×ULN OR direct bilirubin =\\\u003C ULN for participants with total bilirubin levels \\> 1.5 × ULN (Specimens must be collected within 10 days prior to the start of study intervention)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) =\\\u003C 2.5 x ULN (=\\\u003C 5 x ULN for participants with liver metastases) (Specimens must be collected within 10 days prior to the start of study intervention)\n* International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) =\\\u003C 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (Specimens must be collected within 10 days prior to the start of study intervention)\n\nExclusion Criteria:\n\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n  * Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks \\[could consider shorter interval for kinase inhibitors or other short half-life drugs\\] prior to allocation\n\n  * Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to =\\\u003C grade 1 or baseline. Participants with =\\\u003C grade 2 neuropathy may be eligible. Participants with endocrine-related AEs grade =\\\u003C 2 requiring treatment or hormone replacement may be eligible\n  * Note: If the participant had major surgery, the participant must have recovered adequately from the procedure and\u002For any complications from the surgery prior to starting study intervention\n* Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=\\\u003C 2 weeks of radiotherapy) to non-central nervous system (CNS) disease\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist registered trademark) are live attenuated vaccines and are not allowed\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded\n* Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention\n* Has severe hypersensitivity (\\>= grade 3) to pembrolizumab and\u002For any of its excipients\n* Has 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 (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n* Has an active infection requiring systemic therapy\n* Has a known history of Human Immunodeficiency Virus (HIV) infection. However, subjects who are on anti-retroviral therapy, have a viral load \\\u003C 200 copies\u002Fmilliliter, and CD4 count \\> 200\u002Fmicroliter, with a low risk of acquired immunodeficiency syndrome (AIDS)-related outcomes will be considered for enrollment.\n\n  * Note: No HIV testing is required unless mandated by local health authority\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid \\[RNA\\] is detected) infection. Subjects who have underwent treatment with stable hepatitis B (defined as HBV deoxyribonucleic acid \\[DNA\\] \\\u003C 500 IU\u002FmL) are eligible. Patients with prior curative treatment of Hepatitis C virus are allowed if previously treated \\> 2 weeks prior to treatment initiation and HCV RNA undetectable by established laboratory values. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment\n* Has had an allogenic tissue\u002Fsolid organ transplant\n* Subjects who have previously received enfortumab vedotin or other MMAE-based ADCs\n* Subjects with an estimated life expectancy \\\u003C 12 weeks\n* Subjects with known severe (\\>= grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate, and polysorbate 20). Subjects with known severe (\\>= grade 3) hypersensitivity to any pembrolizumab excipient contained in the drug formulations of pembrolizumab\n* Subjects with another underlying medical condition that, in the opinion of the investigator, would impair the ability of the subject to receive or tolerate the planned treatment and follow-up; any known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n* Subjects with active keratitis or corneal ulcerations. Subjects with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the investigator",{"count":456,"type":20},21,[24],"This phase II clinical trial tests how well pembrolizumab plus enfortumab vedotin prior to and after radical nephroureterectomy works in treating patients with high-risk upper tract urothelial cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Enfortumab vedotin (EV) is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of cancer cells. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Radical nephroureterectomy (RNU) is the surgical removal of a kidney and its ureter. Giving pembrolizumab plus enfortumab vedotin before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed and giving pembrolizumab after surgery may kill any remaining cancer cells.",[460],"Renal Pelvis and Ureter Urothelial Carcinoma",{"date":310,"type":33},{"date":463,"type":33},"2024-06-24",{"date":465,"type":20},"2028-01-01",{"name":39,"class":40},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":21,"phases":477,"briefSummary":478,"conditions":479,"keywords":481,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":70},"100638931","rad-onc-freedom-oncology-pain-100638931","NCT07605546","RAD ONC FREEDOM Oncology Pain","Functional Radiosurgery for Easing or Eliminating Debilitating Oncologic Morbidity (FREEDOM)","FREEDOM","Inclusion Criteria:\n\n1. Male or female ≥ 18 years of age on day of SRS treatment.\n2. Documentation of insufficiently controlled mixed, complex cancer pain based on Brief Pain Inventory (BPI) \\>8\u002F10 despite optimization of opioid regimen\n3. Not eligible for or willing to undergo further pain-relieving interventions\n4. Written informed consent (and assent when applicable) obtained from patient or patient's legal representative and ability for patient to comply with the study requirements and agree to undergo the study's SRS treatment plan.\n\nExclusion Criteria:\n\n1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.\n2. Claustrophobia or inability to life flat\n3. Inability to undergo routine imaging studies\n4. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n5. Current history of intracranial malignancy or brain metastasis\n6. Any prior intracranial irradiation\n7. Previous history of craniotomy, deep brain stimulation (DBS) or laser interstitial themal therapy (LITT).\n8. Presence of intracranial hardware such as leads for DBS or any other material that may interfere with safe treatment.\n9. Any comorbidity or condition which would limit full compliance with the protocol",{"count":476,"type":20},19,[131],"The investigators propose to conduct a study in medically refractory cancer pain patients utilizing radiosurgery to ablate the pituitary hypophysis, as well as neuromodulate the centromedian and parafascicular complexes within the thalami - the so-called triple target. This involves treating the pituitary hypophysis and thalamus to a dose of 90 Gy. These patients will have previously failed to achieve adequate pain control with opioid pain regimens and interventional approaches. The trial will involve a multidisciplinary approach involving radiation oncology, neurosurgery, palliative care, and medical oncology colleagues across UCLA.",[480],"Cancer Pain",[482],"reduction","2026-07-06",{"date":485,"type":33},"2026-07-08",{"date":487,"type":33},"2026-06-09",{"date":489,"type":20},"2029-06-01",{"name":39,"class":40},{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":500,"conditions":501,"keywords":4,"overallStatus":259,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":518,"leadSponsor":520,"locationsCount":70},"100632709","a-prospective-study-of-physical-function-in-adults-who-receive-systemic-therapy-for-stage-i-iii-gastroesophageal-cancer-fast-go-study-100632709","NCT07517211","A Prospective Study of Physical Function in Adults Who Receive Systemic Therapy for Stage I-III Gastroesophageal Cancer, FAST-GO Study","A Prospective Study of Physical Function in Adults Who Receive Systemic Therapy for Stage I-III Gastroesophageal Cancer (FAST-GO)","Inclusion Criteria:\n\n* \\* Adults ≥ 18 years old at the start of study treatment.\n\n  * New diagnosis of early-stage (Stage I, II, III) esophageal, gastroesophageal junction, or gastric adenocarcinoma, squamous cell carcinoma, or poorly differentiated carcinoma.\n  * Plan to start systemic therapy for resectable or potentially resectable disease.\n  * Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* \\* Patients with stage I disease with plans to undergo endoscopic resection or surgery alone without perioperative systemic therapy.\n\n  * Metastatic disease at the time of diagnosis.\n  * Patients who are unable to provide informed consent.\n  * Any condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n  * Currently participating in another intervention research study seeking to improve functional status, alleviate frailty, increase muscle strength, or improve cognitive function.",{"count":499,"type":20},72,"This study evaluates how the treatment for gastroesophageal cancer affects physical function in patients who receive chemotherapy as part of their treatment for gastroesophageal cancer.",[502,503,504,505,506,507,508,509,510,511,512,513],"Clinical Stage I Esophageal Adenocarcinoma AJCC v8","Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage I Gastric Cancer AJCC v8","Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage II Esophageal Adenocarcinoma AJCC v8","Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage II Gastric Cancer AJCC v8","Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage III Esophageal Adenocarcinoma AJCC v8","Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","2026-07-02",{"date":516,"type":33},"2026-07-07",{"date":264,"type":20},{"date":519,"type":20},"2029-12-01",{"name":39,"class":40},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":21,"phases":529,"briefSummary":530,"conditions":531,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":533,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":539},"100591411","phase-2-ivonescimab-for-the-treatment-of-thymic-cancer-100591411","NCT06980077","Ivonescimab for the Treatment of Thymic Cancer","UCLA L-11: A Phase II Trial of Ivonescimab for Previously Treated Thymic Carcinoma","Inclusion Criteria:\n\n* Male or female ≥ 18 years of age and willing and able to provide informed consent\n* Cytologically or histologically confirmed thymic carcinoma, which is incurable\n* Received prior systemic therapy for thymic carcinoma, or is ineligible for or refuses other therapies\n* Measurable disease, as per RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL\n* Platelets ≥ 100 × 10\\^9\u002FL\n* Hemoglobin ≥ 9 g\u002FdL or ≥ 5.6 mmol\u002FL\n* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) ≥ 50 mL\u002Fmin (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or CrCl)\n\n  * Estimated glomerular filtration rate (eGFR) value ≥ 50 mL\u002Fmin for participants with creatinine levels \\> 1.5 x institutional ULN\n  * Creatinine clearance may be calculated using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) may be calculated using the Modification of Diet in Renal Disease (MDRD) GFR equation\n* Urine dipstick protein ˂ 2+ OR 24 hour urine protein quantification ˂ 1.0 g\n* Serum total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 2.5 x ULN OR ≤ 5 x ULN for participants with liver metastases\n* Albumin ≥ 2.5 g\u002FdL\n* International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy, and then only as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants\n* Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy, and then only as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n* Female participants of childbearing potential must have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the participant to be eligible. Female participants must agree to use a highly effective method of contraception from the beginning of screening until 120 days after the last dose of the ivonescimab, or be of non-childbearing potential. Non-childbearing potential is defined as follows (by other than medical reasons):\n\n  * ≥ 45 years of age and has not had menses for \\> 2 years,\n  * Participants who have been amenorrhoeic for \\\u003C 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation, or\n  * Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation\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* Male and female participants must agree not to donate sperm or eggs, respectively, from the first study-drug treatment through 120 days after the last study drug treatment\n* Female participants must agree to not breastfeed during the study or for 120 days after the last dose of study treatment\n\nExclusion Criteria:\n\n* Prior treatment with an immune checkpoint inhibitor targeted PD-1 or PD-L1. Prior treatment with VEGF inhibitor is allowed\n* Concurrent enrollment in another clinical study, unless enrolled only in the follow-up period or an observational study\n* Any chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment in the prior 3 weeks or within 5 half-lives of the medication, whichever is shorter. Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable\n* Thoracic radiation of ≥ 30 Gy within 3 months. Other radiation within 3 weeks with the following exceptions: (a) Stereotactic, palliative radiation for bone metastases is acceptable without a washout; (b) Stereotactic brain radiation for asymptomatic brain metastases is acceptable with a 7 day washout\n* Use of any investigational anticancer therapy received within 21 days prior to the first dose of study drug\n* Has not recovered (recovery is defined as National Cancer Institute \\[NCI\\] Common Terminology Criteria for Adverse Events \\[CTCAE version (v)5.0\\] grade ≤ 1) from the acute toxicities of previous therapy, except treatment-related alopecia, sensory neuropathy, or laboratory abnormalities otherwise meeting the inclusion requirements stated in the inclusion criterion. Other grade 2 or less toxicities not constituting a safety risk based on the investigator's judgment are acceptable\n* The patient has a known allergy\u002Fhistory of hypersensitivity reaction to any of the treatment components or any other contraindication to one of the administered treatments\n* Active autoimmune condition currently requiring systemic immune suppressive therapy\n* Positive paraneoplastic serologies, including binding, blocking and modulating antibodies to acetylcholine receptor (AChR)\n\n  * If known muscle-specific kinase (MuSK) antibodies positive then excluded, otherwise additional testing not required\n* Major surgical procedures or serious trauma within 4 weeks prior to randomization, 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 randomization\n* Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n* Presence of angina or active cardiac ischemia, uncontrolled congestive heart failure of current ≥ class III as defined by the New York Heart Association, or unstable cardiac arrhythmia (e.g., clinically stable atrial fibrillation is permitted)\n* The patient has experienced myocardial infarction within 6 months prior to study enrollment\n* History of arterial or venous thrombosis or thromboembolism within 6 months prior to study enrollment. Patients with a history of venous thromboembolism beyond 6 months prior to study enrollment can be enrolled if they are appropriately anticoagulated\n* Imaging during the screening period shows that the tumor surrounds important blood vessels or has obvious necrosis and\u002For cavitation, and the investigator determines that entering the study is a bleeding or fistula risk. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted\n* The patient has any ongoing or active infection requiring the use of parenteral anti-microbial agents, or grade \\> 2 by NCI CTCAE (v5.0) within 14 days prior to enrollment. Patient with a history of HIV with an undetectable viral load and cluster of differentiation 4 (CD4) count over 200 are eligible. Patients with a history of hepatitis B or hepatitis C, an undetectable viral load, and liver function test (LFT) testing which meets criteria for the study are eligible\n* The patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 210 days after the last dose of trial treatment\n* Progressive or symptomatic brain metastases. Brain metastases that have been radiated, are asymptomatic, and on a stable or decreasing dose of steroids are allowed. Leptomeningeal disease is excluded\n* History of another cancer within 2 years of study initiation, with the exception of fully treated cancers unlikely to affect the assessment of the study treatment safety or efficacy including early stage breast, prostate, bladder, non-melanomatous skin, thyroid, cervical, or endometrial cancer\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to randomization, including but not limited to:\n\n  * Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots)\n\n    * 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 randomization 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. 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 randomization\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 randomization\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 randomization, 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\n* Has pre-existing peripheral neuropathy that is ≥ grade 2 by CTCAE version 5\n* Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic\n\n  * Patients managed with indwelling catheters (eg, PleurX) are allowed\n* History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease\n* Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Known history of human immunodeficiency virus (HIV) whose viral load is not controlled\n* Current use of systemic corticosteroids (\\> 10 mg daily prednisone or equivalent)\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n* Live vaccine or live attenuated vaccine within 4 weeks prior to planned randomization, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted\n* Participants must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent\n* Patient unwilling or unable to comply with the protocol\n* Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product or interpretation of subject safety or study results",{"count":7,"type":20},[24],"This phase II trial tests how well ivonescimab works in treating patients with thymic carcinoma. Immunotherapy with monoclonal antibodies, such as ivonescimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.",[532],"Thymus Carcinoma",{"date":516,"type":33},{"date":535,"type":33},"2025-07-15",{"date":537,"type":20},"2028-06-17",{"name":39,"class":40},5,{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":21,"phases":548,"briefSummary":550,"conditions":551,"keywords":4,"overallStatus":259,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":552,"startDateStruct":553,"completionDateStruct":554,"leadSponsor":556,"locationsCount":70},"100550531","phase-3-ph-weighted-chemical-exchange-saturation-transfer-mri-based-surgical-resection-to-improve-survival-in-patients-with-glioblastoma-100550531","NCT06448286","PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glioblastoma","PH Weighted Chemical Exchange Saturation Transfer Based Surgical Resections of Glioblastoma","Inclusion Criteria:\n\n* Male or female ≥ 18 years of age\n* Documentation of a newly diagnosed World Health Organization (WHO) grade IV glioblastoma as evidenced by clinical features and imaging data\n* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study\n\nExclusion Criteria:\n\n* Male or female \\\u003C 18 years of age\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data\n* Not medically cleared for surgery\n* Previous treatment (any chemotherapy, molecular therapy, immunotherapy, or radiation therapy)",{"count":129,"type":20},[549],"PHASE3","This phase III trial compares pH weighted chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI)-based surgical resections to standard of care surgical resections for the treatment of patients with glioblastoma. Standard of care therapy for glioblastoma is surgery to remove tumor tissue that enhances on standard MRI imaging, however, it has been shown that significant tumor burden exists in the region around the tumor tissue that does not enhance with standard MRI. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and tumor tissue. CEST MRI is a technique that uses differences in the tissue environment, like protein concentration or intracellular pH, to generate contrast differences. CEST MRI may identify tumor tissue that does not enhance with standard of care MRI. PH weighted CEST MRI based surgical resection may be more effective compared to standard of care surgical resection in treating patients with glioblastoma.",[304],{"date":516,"type":33},{"date":264,"type":20},{"date":555,"type":20},"2031-12-01",{"name":39,"class":40},{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":103,"minAge":18,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":565,"conditions":566,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":567,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":571,"locationsCount":70},"100421236","integrating-quantitative-mri-and-artificial-intelligence-to-improve-prostate-cancer-classification-100421236","NCT04765150","Integrating Quantitative MRI and Artificial Intelligence to Improve Prostate Cancer Classification","Inclusion Criteria:\n\n* Male patients 18 years of age and older\n* Clinical suspicion of prostate cancer or biopsy-confirmed prostate cancer\n* Undergone or undergoing multi-parametric 3 T prostate MRI at the University of California at Los Angeles (UCLA)\n* Ability to provide consent\n\nExclusion Criteria:\n\n* Contraindications to MRI (e.g., cardiac devices, prosthetic valves, severe claustrophobia)\n* Contraindications to gadolinium contrast-based agents other than the possibility of an allergic reaction to the gadolinium contrast-based agent\n* Prior radiotherapy",{"count":564,"type":20},275,"This study evaluates how new magnetic resonance imaging (MRI) and artificial intelligence techniques improve the image quality and quantitative information for future prostate MRI exams in patients with suspicious of confirmed prostate cancer. The MRI and artificial intelligence techniques developed in this study may improve the accuracy in diagnosing prostate cancer in the future using less invasive techniques than what is currently used.",[395],{"date":516,"type":33},{"date":569,"type":33},"2021-04-01",{"date":68,"type":20},{"name":39,"class":40},{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":579,"sex":127,"minAge":580,"maxAge":581,"enrollmentInfo":582,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":584,"conditions":585,"keywords":588,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":591,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":70},"100385308","brain-health-in-breast-cancer-survivors-100385308","NCT04297020","Brain Health in Breast Cancer Survivors","Brain Health in Breast Cancer Survivors: Interaction of Menopause and Endocrine Therapy","Inclusion Criteria:\n\n* Age 35-65\n* Fluent in English\n* Adequate vision\u002Fhearing to complete testing\n\nExclusion Criteria:\n\n* History of major or mild neurocognitive disorder or dementia\n* Diagnosis of major neurological condition (e.g., epilepsy, Parkinson's Disease, stroke)\n* Diagnosis of a major psychiatric disorder (e.g., bipolar disorder, schizophrenia)\n* Untreated\u002Funstable unipolar depression or anxiety\n* Prior history of cancer or chemotherapy (for controls, any history)\n* History of a learning disorder\n* History of head injury with loss of consciousness \\>20 minutes\n* History of salpingo-oophorectomy or hysterectomy\n* A cardiac pacemaker\n* Implanted electronic device\n* Claustrophobia\n* Currently pregnant\n* Orbital metal implant or other metallic foreign bodies\n\nAdditional exclusion criteria for controls: current use of a contraceptive agent that interferes with endogenous hormonal fluctuation (e.g., oral contraceptive pill) or precludes determination of menstrual pattern (e.g., hormonally secreting intrauterine device), or current treatment with systemic estrogen replacement therapy.",true,"35 Years","65 Years",{"count":583,"type":20},120,"Endocrine therapy (ET) is widely used to treat hormone receptor positive breast cancer and prevent recurrence by downregulating estrogen function. However, ETs readily cross the blood brain barrier and interfere with the action of estrogen in the brain. Estrogen supports cognition and menopausal status is closely linked to cognitive health in women. This has raised concern that anti-estrogen ETs may affect cognition and brain health in breast cancer survivors. However, evidence across existing studies is inconsistent and these effects remain poorly understood. The incomplete understanding of the effects of ET are likely due to limitations of earlier studies - namely, the under-appreciation of the role of menopausal status and insensitivity of standard cognitive measures. This research project will address these earlier limitations by specifically comparing ET effects by menopausal status, and using highly sensitive, task-related functional magnetic resonance imaging (fMRI) measures to assess the effects of ET on brain function.",[586,587],"Cognitive Impairment","Cognitive Function",[589,590],"Breast cancer","endocrine therapy",{"date":516,"type":33},{"date":593,"type":33},"2020-03-11",{"date":595,"type":20},"2028-03-15",{"name":39,"class":40},""]