[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoplasms":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,136,0,25,[9,53,79,110,146,172,195,220,244,276,304,324,356,380,410,435,494,513,539,564,585,623,649,686,758],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100648006","hepatic-artery-infusion-of-carfilzomib-in-participants-with-liver-metastatic-disease-previously-treated-with-hepatic-artery-infusion-pump-therapy-100648006",false,"NCT07715903","Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy","Phase I Study Evaluating Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy","* INCLUSION CRITERIA:\n* Participants must have a histologically or cytologically confirmed by pathology report diagnosis of colorectal cancer (CRC), intrahepatic cholangiocarcinoma (ICC), or adrenocortical carcinoma (ACC).\n* Participants must have measurable liver-dominant metastatic disease. Note: liver-dominant metastatic disease is defined as \\>=75% of metastatic disease present in the liver as assessed by the principal investigator.\n* Extrahepatic disease should be treated with anticancer therapy, if applicable, and should be stable by RECIST criteria for at least 6 weeks prior to study treatment initiation.\n* Participants must have previously undergone hepatic artery infusion pump therapy and have a functioning hepatic artery infusion pump in place.\n* Participants must have progressed on, been intolerant of, or have residual disease after HAI floxuridine and appropriate current standard-of-care treatment.\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C= 2.\n* Participants must have an adequate organ and marrow function as defined below:\n\nLeukocytes \\> 3,000\u002FmcL\n\nHemoglobin \\>= 9 mg\u002FdL\n\nAbsolute neutrophil count \\> 1,500\u002FmcL\n\nPlatelets \\> 100,000\u002FmcL\n\nTotal bilirubin \\\u003C 2 X institutional upper limit of normal (ULN)\n\nAspartate aminotransferase (AST) \\\u003C 2.5 X institutional (ULN)\n\nAlanine aminotransferase (ALT) \\\u003C 2.5 X institutional (ULN)\n\nCreatinine \\\u003C2 X institutional (ULN)\n\n* Participants positive for human immunodeficiency virus (HIV) 1\u002F2 antibody must have a negative HIV viral load.\n* Participants positive for Hepatitis C (HCV) antibody must have a negative HCV viral load.\n* Participants positive for Hepatitis B (HBV) core antibody (HBcAb) must have a negative HBV viral load. Note: Participants positive for Hepatitis B surface antigen (HBsAg) are excluded.\n* Women of childbearing potential (WOCBP) must agree to use effective contraception (barrier, hormonal, intrauterine device, abstinence, surgical sterilization) at the study entry and up to 6 months after the last dose of the study drug. A participant may request a male partner to use an effective form of contraception to fulfill this requirement (e.g., condom\u002Fbarrier).\n\nMen must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 3 months after the last dose of the study drug. A participant may request a female partner to use an effective form of contraception to fulfill this requirement (e.g., intrauterine device, hormonal contraceptives). Men must not freeze or donate sperm within the same period.\n\n* Women who are breastfeeding or plan to breastfeed must agree to discontinue\u002Fpostpone breastfeeding from study treatment initiation through 2 weeks after the last dose of the study drug.\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Participants with liver metastases amenable to resection.\n* Participants who received floxuridine within 6 weeks prior to the study treatment initiation.\n* Participants who received any anticancer therapy within 2 weeks prior to the study treatment initiation.\n* Participants who received any investigational agents within 4 weeks prior to the study treatment initiation.\n* Participants with incontrovertible radiographic evidence of disease progression per the RECIST definition outside of the liver within 3 months prior to the study treatment initiation. Note: Pulmonary lesions less than 1 cm are allowed.\n* Prior radiation to the liver (Yttrium-90 \\[Y-90\\] or External Beam Radiation Therapy \\[EBRT\\]).\n* History of allergic reactions attributed to compounds of similar chemical composition to CFZ.\n* Positive serum or urine Beta-human chorionic gonadotropin (Beta-HCG) pregnancy test performed at screening.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, evaluated by medical history, electrocardiogram (EKG), physical exam, and laboratory testing, or social situations that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements.","ALL","18 Years","120 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Background:\n\nCancers that begin in the colon, adrenal glands, or bile ducts may spread to the liver. These liver tumors are often treated using a hepatic artery infusion (HAI) pump. The HAI pump is installed in the artery that goes to the liver; drugs are administered directly to the liver through this pump. But these tumors often return after treatment. Carfilzomib (CFZ) is a drug approved to treat another kind of cancer. Researchers want to find out if this drug may be helpful when administered through the HAI pump directly to the liver for people with colon, adrenal glands, or bile duct cancer that has spread to the liver.\n\nObjective:\n\nTo test the safety of carfilzomib (CFZ) delivered via a hepatic artery infusion (HAI) pump directly to the liver in people with cancer in their liver.\n\nEligibility:\n\nPeople aged 18 years or older with cancers of the colon, adrenal glands, or bile ducts that spread to the liver and persist after treatment. They must have a functioning hepatic artery infusion (HAI) pump in place from previous treatment of HAI pump therapy.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam, blood tests, imaging scans, and a test of their heart function. They will also have a test to show how the blood flows through their liver: A radioactive substance will be injected into a vein, and a special camera will take pictures of the blood flow for up to 1 hour.\n\nParticipants will receive the study drug for about 6 months. They will visit the clinic once a week. Their HAI pump will be filled with the drug at each visit; the drug will slowly drain from the pump into the liver. Blood tests and imaging scans will be repeated during the study.\n\nParticipants will have follow-up visits 1 and 3 months after their last dose of study drug.\n\nAn optional liver biopsy (tissue sample) for research purposes may be done before the study drug is given, and again (optional) within 28 days after first receiving the study drug. Individuals may participate in the study even if they do not agree to have the biopsies done.\n\n...",[28,29,30,31,32],"Colorectal Neoplasms","Neoplasms","Intrahepatic Cholangiocarcinoma","Adrenocortical Carcinoma","Metastasis, Neoplasm",[34,35,36,37,38,39],"Hepatic artery infusion","Carfilzomib","Colorectal Cancer","Intrahepatic cholangiocarcinoma","Adrenocortical Cancer","Measurable liver metastasis","NOT_YET_RECRUITING","2026-08-20",{"date":43,"type":44},"2026-08-21","ACTUAL",{"date":46,"type":22},"2026-08-26",{"date":48,"type":22},"2031-12-31",{"name":50,"class":51},"National Cancer Institute (NCI)","NIH",1,{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":12,"sex":60,"minAge":18,"maxAge":19,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":65,"conditions":66,"keywords":72,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":76,"leadSponsor":78,"locationsCount":52},"100641793","multitargeted-recombinant-ad5-psamuc-1brachyury-based-immunotherapy-triadeno-vaccine-with-il-15-superagonist-n-803-in-participants-with-clinically-localized-prostate-cancer-undergoing-active-surveillance-100641793","NCT07574541","Multitargeted Recombinant Ad5 PSA\u002FMUC-1\u002FBrachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","Phase II Trial of a Multitargeted Recombinant Ad5 PSA\u002FMUC-1\u002FBrachyury-based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","* INCLUSION CRITERIA:\n* Histologically confirmed diagnosis of organ confined, low- or intermediate-risk PCa (Gleason grade group 1 or 2) identified in at least one prostate biopsy core. Biopsies performed at outside institutions should have Gleason score confirmed at the NCI by a genitourinary (GU) pathologist.\n* Participants must be on active surveillance.\n* Pre-study treatment tissue availability (at least one formalin-fixed paraffin embedded \\[FFPE\\] biopsy core or one H and E-stained slide and at least 5 unstained slides) obtained between 3 and 24 months prior to treatment initiation is mandatory for study initiation.\n* Serum PSA level of \\\u003C20 ng\u002FmL (or \\\u003C10ng\u002FmL for participants being treated with 5- alpha-reductase inhibitors)\n* Clinical stage \\\u003C=T2a by digital rectal exam (DRE)\n* Age \\>=18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C=1.\n* Adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>=1.0 x 109\u002FL\n  * Hemoglobin (Hgb) \\>=9 g\u002FdL\n  * Platelets \\>=75,000\u002FmcL\n  * Prothrombin International Normalized Ratio (INR) \\\u003C1.5 x upper limit of normal (ULN)\n  * Partial thromboplastin time (PTT) \\\u003C1.5 x ULN\n  * Total bilirubin \\\u003C1.5 x ULN\n  * Aspartate aminotransferase (AST) \\\u003C=2.5 x ULN\n  * Alanine aminotransferase (ALT) \\\u003C=2.5 x ULN\n  * Creatinine \\\u003C=1.5 x ULN\n\nOR\n\n--Calculated Creatinine clearance \\>=40 mL\u002Fmin\u002F1.73 m2 for individuals with creatinine levels above institutional normal (using either Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n\n* Treatment with steroid therapy must have a washout of at least 6 weeks prior to initiation of study treatment. Physiologic (replacement) doses of steroids as well as nasal, topical, or inhaled steroids are allowed.\n* Vaccination with a live (attenuated) vaccine (e.g., FluMist(R)) or a killed (inactivated)\u002Fsubunit vaccine (e.g., PNEUMOVAX(R), Fluzone(R)) must occur not sooner than 28 days or 14 days, respectively, prior to initiation of study treatment.\n* Participants must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to one (1) month after the last vaccine injection. We also will recommend participants with female partners of childbearing potential to ask them to be on highly effective birth control (hormonal, intrauterine device \\[IUD\\], surgical sterilization). Participants must not freeze or donate sperm within the same period.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Prior treatment for PCa by surgery, radiation, local ablative (i.e., cryosurgery or highintensity focused ultrasound), or androgen-deprivation therapy.\n* Evidence of PCa with metastatic disease.\n* Prior treatment with adenovirus-based vector immunotherapy, adenovirus-based vaccines, or investigational vaccines.\n* Prior solid organ or bone marrow transplant.\n* Immunodeficiency or splenectomy.\n* Presence of a known active acute or chronic infection, including human immunodeficiency virus (HIV), confirmed by PCR, and hepatitis B virus (HBV) and hepatitis C virus (HCV), as determined by hepatitis B surface antigen (HBsAg) and HCV serology.\n* History of autoimmune disease (active or past), except for autoimmune-related thyroid disease, type I diabetes, and vitiligo if the condition(s) is well controlled.\n* History of heart disease, such as congestive heart failure (class II, III, or IV defined by the New York Heart Association functional classification), history of unstable or poorly\n\ncontrolled angina, or history (\\\u003C1 year prior to initiation of study therapy) of ventricular arrhythmia.\n\n* Acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions.\n* Second malignancy within 3 years prior to initiation of study therapy. Note: Individuals with curatively treated non-melanoma skin cancers or non-muscle invasive bladder cancer will not be excluded.\n* History of herbal products that may decrease PSA levels (e.g., saw palmetto).\n* Participants who have undergone surgery within 4 weeks prior to initiation of study therapy.\n* Participants receiving any other investigational agents within 30 days prior to initiation of study therapy.\n* History of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements suggested by medical history, physical examination, or standard clinical assessments such as imaging, EKG, and laboratory studies.","MALE",{"count":62,"type":22},52,[64],"PHASE2","Background:\n\nProstate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) approved for bladder cancer can help stop prostate tumors from growing.\n\nObjective:\n\nTo test TriAdeno and N-803 in people with early-stage prostate cancer.\n\nEligibility:\n\nPeople aged 18 years and older with early-stage low- or medium-risk prostate cancer.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have an imaging scan. They may have a rectal exam.\n\nTriAdeno is injected under the skin of the upper thigh; N-803 is injected under the skin of the abdomen. Participants will be treated in up to four 21-day cycles. They will get both injections on the first day of each cycle.\n\nParticipants may opt to complete a memory aid: They may record all of their symptoms for 7 days after each injection. They may also complete a questionnaire about their prostate symptoms.\n\nBlood tests, imaging scans, and other tests will be repeated during the study.\n\nA tissue sample (biopsy) of the tumor will be collected during or after cycle 2; a second biopsy may be taken about 1 year later.\n\nParticipants will have follow-up phone calls for 5 years....",[67,68,29,69,70,71],"Adenocarcinoma","Prostate Cancer","Carcinoma","Neoplasms, Glandular and Epithelial","Neoplasms by Histologic Type",[73],"Immune Infiltration",{"date":43,"type":44},{"date":46,"type":22},{"date":77,"type":22},"2028-06-15",{"name":50,"class":51},{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":109},"100606000","phase-2-a-study-to-evaluate-ly3537021-for-the-treatment-of-nausea-and-vomiting-caused-by-chemotherapy-in-adults-with-cancer-100606000","NCT07169851","A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer","A Phase 2, Double-blind, Placebo-Controlled Study to Evaluate LY3537021 for the Treatment of Chemotherapy-Induced Nausea and Vomiting in Adult Participants With Malignant Disease","Inclusion Criteria:\n\n* Chemotherapy-naive participants, planned to receive AC or cisplatin-based chemotherapy greater than or equal to (≥)70 milligrams per square meter (mg\u002Fm²), on Day 1 of each cycle, with no multiple administrations during the CINV observation period, from Day 2 to Day 5 of each cycle.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n\nExclusion Criteria:\n\n* Have symptomatic or untreated central nervous system (CNS) metastases.\n* Have an established diagnosis of uncontrolled diabetes mellitus.\n* Have a history of, or current evidence of, a clinically significant cardiac condition or QT\u002FQTcF-related conditions.\n* Have another etiology for nausea and vomiting, or receives medications with know or potential antiemetic activity\n* Signs, symptoms or history of thyroid tumors\n* Receives treatment with a gastric inhibitory polypetide (GIP) or glucagon-like peptide-1 (GLP-1) receptor agonist within 4 weeks prior to chemotherapy.\n* Have participated in a clinical study involving study intervention within 30 days of Cycle 1 Day 1 (C1D1). If the previous study intervention has a long half-life, within 3 months or 5 halflives, whichever is longer, of C1D1.\n* Are pregnant, breastfeeding, or intend to become pregnant during the study or within 30 days of the last dose of study intervention.",{"count":87,"type":22},204,[64],"The purpose of this study is to check how well LY35327021 works and how safe it is for controlling nausea and vomiting caused by chemotherapy. Participants who join this study will be in it until all parts are finished, which could take about 2 months.",[91,92,93,29],"Nausea","Vomiting","Drug-Related Side Effects and Adverse Reactions",[95,96,97,98,99],"Chemotherapy-Induced Nausea and Vomiting (CINV)","Anthracycline and cyclophosphamide (AC)","Glucose-dependent Insulinotropic Peptide (GIP)","Incretins","Cisplatin","RECRUITING",{"date":43,"type":44},{"date":103,"type":44},"2025-11-28",{"date":105,"type":22},"2027-02",{"name":107,"class":108},"Eli Lilly and Company","INDUSTRY",68,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":129,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":52},"100584158","phase-1-anti-mesothelin-tnaivescm-hyp218-tnhyp218-car-t-cells-in-participants-with-mesothelin-expressing-solid-tumors-including-mesothelioma-100584158","NCT06885697","Anti-Mesothelin TNaive\u002FSCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma","Phase 1 Study With Dose Expansion of the Anti-Mesothelin TNaive\u002FSCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria. For this protocol, treatment initiation is defined as the first day of lymphodepleting chemotherapy.\n\n* Participant must have unresectable, locally advanced, or metastatic, or recurrent mesothelioma and other mesothelin expressing solid tumors. For participants with mesothelioma only those with epithelioid or biphasic histology (with \\>80% epithelioid component) will be eligible. The diagnosis will be confirmed by the Laboratory of Pathology, CCR, NCI.\n* Participant must have progressed on at least one FDA-approved systemic therapy considered standard of care for their tumor type. There is no limit on the number of prior treatment regimens. Note: Given the aggressive nature of pancreatic cancer, otherwise eligible individuals with this cancer type can undergo leukapheresis before or while they are getting their frontline treatment as long as they meet all other inclusion criteria. However, TNhYP218 CAR T cells will only be administered after progression on first line standard of care therapy.\n* Participant must have at least 1 measurable lesion by RECIST version 1.1.\n* Tumor must have MSLN positivity of 2+ to 3+ in \\>= 50% cancer cells by immunohistochemistry on freshly collected biopsy or archival tissue.\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have adequate organ and marrow function as defined below:\n\nSystem: Laboratory Value\n\nHematological\n\n* Hemoglobi: \\>=9 g\u002FdL(a)\n* absolute neutrophil count: \\>=1,500\u002FmcL\n* platelets: \\>=100,000\u002FmcL\n\nHepatic\n\n* total bilirubin: \\\u003C=2.5 X institutional ULN OR direct bilirubin ULN for participants with total bilirubin levels \\>1.5 X ULN\n* AST and ALT \\\u003C= 2.5 X institutional ULN (\\\u003C= 5 X ULN for participants with liver metastases)\n\nRenal\n\n* Creatinine OR: \\\u003C=1.5 X ULN OR\n* Calculated(b) creatinine clearance (GFR can also be used in place of creatinine or CrCl) \\>= 50 mL\u002Fmin for participant with creatinine levels \\> 1.5 X institutional ULN\n\nCoagulation\n\n* International normalized ratio (INR) OR prothrombin time (PT): \\\u003C=1.5 X ULN unless participant is receiving anticoagulant therapy if PT or aPTT is within therapeutic range of intended use of anticoagulants\n* Activated partial thromboplastin time (aPTT): \\\u003C=1.5 X ULN unless participant is receiving anticoagulant therapy if PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.\n\n1. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.\n2. Creatinine clearance (CrCl) should be calculated per institutional standard.\n\n   * Normal cardiac ejection fraction (\\>= 45% by echocardiogram) and no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram.\n   * Room air oxygen saturation of 90% or greater.\n   * Treatment-related toxicities from prior treatments must be resolved to \\\u003C= grade 2.\n   * Participants with CNS metastases, leptomeningeal disease or carcinomatous meningitis are eligible if they are asymptomatic, have completed their treatment for CNS disease and have recovered from the acute effects of radiation therapy or surgery prior to study entry. Participants must have radiographically stable CNS disease without associated edema at least three months prior to study entry. Additionally, participants have had to have discontinued corticosteroid treatment or non-prophylactic antiseizure medications for these metastases at least four weeks prior to study entry.\n   * Participants of child-bearing potential and participants who can father children must agree to use highly effective contraception or abstinence.\n   * Participants who are nursing or plan to nurse a child must agree to discontinue\u002Fpostpone nursing for the duration of study therapy and for 12 months after the administration of the cell product or for 4 months from the time no evidence of persistence\u002Fgene modified cells is documented in the participant s blood.\n   * Ability of participant to understand and the willingness to sign a written informed consent document.\n\n   EXCLUSION CRITERIA:\n\n   An individual who meets any of the following criteria will be excluded from participation in this study:\n   * Prior systemic therapy, an investigational therapy, radiation, and\u002For surgery within 14 days prior to leukapheresis and 21 days prior to lymphodepleting chemotherapy.\n   * Prior administration of anti-PD-1 or anti-PD-L1 antibodies or other agents that in the opinion of the PI can stimulate immune activity and interfere with an infusion of CAR-T cells within 8 weeks prior to treatment initiation.\n   * Participants with any form of primary immunodeficiency (e.g. severe combined immunodeficiency).\n   * Participants with active or history of autoimmune or immune mediated disease such as multiple sclerosis, lupus, inflammatory bowel disease, rheumatoid arthritis, or small vessel vasculitis. NOTE: Participants with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.\n   * History of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine.\n   * Therapeutic doses of systemic corticosteroid therapy within 14 days prior to treatment initiation. Physiological doses of steroids (up to 5mg\u002Fday of prednisolone or equivalent) are allowed. Corticosteroid creams, ointments, and eye drops are allowed.\n   * Participants with lung fibrosis, inflammatory lung disease or evidence of pneumonitis on baseline imaging studies or medical history of these disorders.\n   * Participant has any other prior or concurrent malignancy with the following exceptions:\n\n     * Adequately treated basal cell or squamous cell carcinoma\n     * In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 12 months prior to initiation of study therapy.\n     * Treated non-melanoma skin cancer.\n     * Stage 0 or 1 melanoma completely resected at least 12 months prior to initiation of study therapy.\n     * Successfully treated organ-confined prostate cancer with no evidence of progressive disease based on PSA levels and are not on active therapy.\n     * A primary malignancy which has been completely resected and in complete remission for \\>= 5 years.\n   * Electrocardiogram showing a QTc interval \\> 450 msec in males and \\> 470 msec in females (\\> 80 msec for participants with bundle branch block). Either Fridericia s or Bazett s formula may be used to correct the QT interval.\n   * Participant has active infection with HIV, hepatitis B virus, HCV, or HTLV as defined below:\n\n     * Positive serology for HIV, HTLV-1, or HTLV-2.\n     * Active hepatitis B infection as demonstrated by test for hepatitis B surface antigen. Participants who are hepatitis B surface antigen negative but are hepatitis B core antibody positive must have undetectable hepatitis B DNA and receive prophylaxis against viral reactivation.\n     * Active hepatitis C infection as demonstrated by hepatitis C RNA test. Participants who are HCV antibody positive will be screened for HCV RNA by any reverse transcription PCR or branched DNA assay. If HCV antibody is positive, eligibility will be determined based on a negative screening RNA value.\n   * Participant is pregnant or intends to be pregnant during the required period of contraception for participants of childbearing potential.\n   * Participants who received live or attenuated vaccine or virus-based vaccine within 30 days before initiation of treatment initiation\n   * Participants with a history of seizure disorder unless due to now treated metastatic lesions.\n   * Ongoing uncontrolled intercurrent illness, including but not limited to ongoing or active infection, that would impact participant safety or limit compliance with study requirements.",{"count":118,"type":22},100,[25],"Background:\n\nMesothelioma is an aggressive cancer that grows in the linings of the body; this can include the membranes that line the heart, lungs, and internal organs. Mesothelin (MSLN) is a protein that appears in high numbers in many tumors, including mesothelioma. Researchers are developing a new treatment that collects a person s own immune cells (T cells); the T cells are genetically modified to target and kill tumor cells with high levels of MSLN.\n\nObjective:\n\nTo test a new treatment (TNhYP218 CAR T cells) in people with solid tumors including mesothelioma.\n\nEligibility:\n\nPeople aged 18 and older with solid tumors including mesothelioma that returned or spread after standard treatment.\n\nDesign:\n\nParticipants will be screened. A small piece of tissue will be cut from a tumor (biopsy). The sample will be tested to see if it has enough MSLN.\n\nParticipants will undergo leukapheresis: Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein.\n\nParticipant s T cells will be modified in a lab to produce TNhYP218 CAR T cells.\n\nParticipants will enter the hospital. For 7 days, they will receive drugs to prepare their bodies for the study treatment.\n\nTNhYP218 CAR T cells will be administered into a vein. Participants will remain in the hospital for at least 7 more days.\n\nAfter discharge, participants will have follow-up visits for 5 years. These visits may include imaging scans, blood and heart tests, and a new biopsy.\n\nLong-term follow-up will continue another 10 years....",[122,29,123,124,125,126,127,128],"Mesothelioma","Stomach Neoplasms","Pancreatic Neoplasms","Ovarian Neoplasms","Lung Neoplasms","Thymus Neoplasms","Colonic Neoplasms",[130,131,132,133,134,135,136,137,138,139],"Peritoneal Mesothelioma","Thymic Carcinoma","Colon Cancer","Gastric Cancer","Lung Cancer","Ovarian Cancer","Pancreatic Cancer","mesothelin expressing solid tumors","CAR T cell therapy","Gene Therapy",{"date":43,"type":44},{"date":142,"type":44},"2025-07-08",{"date":144,"type":22},"2044-06-01",{"name":50,"class":51},{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":153,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":157,"conditions":158,"keywords":161,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":4,"leadSponsor":170,"locationsCount":171},"100166719","clinical-and-genetic-studies-of-li-fraumeni-syndrome-100166719","NCT01443468","Clinical and Genetic Studies of Li-Fraumeni Syndrome","Clinical, Epidemiologic, and Genetic Studies of Li-Fraumeni Syndrome","* INCLUSION CRITERIA:\n* On referral, persons of all ages will be considered for inclusion in the study\n\nbecause of either:\n\n* A family or personal medical history of neoplasia consistent with the diagnosis of LFS or LFL; or,\n* A personal history of a germline TP53 mutation; or,\n* A first- or second- degree relative of a TP53 mutation carrier, regardless of mutation status; or,\n* A personal history of three or more LFS-related primary cancers; or,\n* A personal history of adrenal cortical carcinoma or choroid plexus carcinoma at any age, regardless of family history\n\nPersonal and family medical history must be verified through questionnaires, interviews, review\n\nof medical records and\u002For review of pathology slides.\n\nThere are 72 families who have previously enrolled in the pilot study under protocol 78-C-0039.\n\nAs the eligibility criteria remain the same, these families will be eligible for this protocol and will be invited to sign the new consent.\n\n-Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nFor both the Field and Clinical Center Cohort, the PI will ensure that study investigators will\n\nidentify an appropriate LAR consistent with requirements of Policy 403 and will obtain consent\n\nfrom the LAR as outlined in the consent process before initiating research interventions.\n\n-Pregnant women\n\nIn order to study the lifetime rates of cancer development in all individuals with Li-Fraumeni\n\nsyndrome, we will need to evaluate what effect pregnancy may have on rate of cancer\n\ndevelopment both in affected individuals and unaffected family controls. Additionally, some\n\ncancers are known to have an increased risk of development in the context of pregnancy and\n\nlactation. Exclusion of pregnant women would preclude understanding of these cancer risks for\n\nan important subset of the population.\n\nPregnant women are eligible for enrollment on the data collection component of this study.\n\nPregnant women will be included in this study as several endpoints may be assessed during\n\npregnancy; counseling, education, and other minimal risk procedures (i.e. blood draw) may be\n\ndone. We will postpone full clinical evaluations at the Clinical Center of pregnant women until\n\nthe subject has recovered post-partum.\n\nAll screening studies, for women who are pregnant, or breastfeeding will be deferred while the\n\nwoman is pregnant or breastfeeding. Pregnancy testing will be performed for females of childbearing age prior to imaging studies, and the test results must be negative prior to the scan..\n\nThe risk to the fetus and pregnant woman would be no greater than minimal for procedures that\n\nare performed.\n\nEXCLUSION CRITERIA:\n\n* Referred individuals and families whose reported diagnoses cannot be verified\n* Medical or psychiatric disorder which, in the opinion of the Principal Investigator, would preclude the ability to participate in clinical research\n* Women who are pregnant will not be eligible for the cancer screening protocol until they recover post-partum. Women participating in the cancer screening protocol will discontinue this component if they become pregnant while on study. Once they recover post-partum, they can continue the cancer screening protocol.",true,{"count":155,"type":22},5000,"OBSERVATIONAL","Background:\n\n\\- Li-Fraumeni syndrome (LFS) is a genetic condition that increases the risk for some types of cancer. LFS may lead to cancer of the bone or connective tissue, breast, and brain. It may also increase the risk for certain types of leukemia and other cancers. The only known cause of LFS is a change (called a mutation ) in a gene known as TP53. However, not all people with LFS have a TP53 mutation. Researchers want to study other possible genetic causes of LFS, and factors that may increase or decrease cancer risk in people with the syndrome.\n\nObjectives:\n\n* To learn more about the types of cancers that occur in individuals with LFS.\n* To study the role of the TP53 gene in the development of cancer.\n* To look for other possible genes that cause LFS\n* To study the effect of LFS diagnosis on families.\n* To determine if environmental factors or other genes can change a person s cancer risk associated with LFS.\n\nEligibility:\n\n* Individuals with a family or personal medical history of cancers consistent with LFS.\n* Individuals with a family or personal medical history of cancers that does not meet the diagnosis of LFS, but the history is suggestive for LFS (meets the diagnosis for the so-called Li-Fraumeni like syndrome)\n* Individuals with certain rare cancers\n* Individuals with a family or personal history of a TP53 gene mutation, with or without related cancer(s).\n\nDesign:\n\n* Participants will fill out a medical history questionnaire and a family history questionnaire.\n* Blood samples will be collected for DNA and for storage. Cheek cell samples may be collected if blood cannot be obtained for DNA. Participants can choose to have or not have cancer screening with blood tests, imaging studies, and other exams.\n* Participants will complete questionnaires about their worries about cancer, stress levels, and coping strategies. Diet and physical activity questionnaires will also be given. Other psychological tests may be given as needed.\n* Participants will be monitored for several years, with regular followup visits to the National Institutes of Health, if indicated. Any changes in health or cancer status will be recorded.",[159,29,160],"Li-Fraumeni Syndrome","Tp53 Mutations",[162,163,164,165,166],"Tp53","Cancer","Hereditary","Genetic Testing","Screening",{"date":43,"type":44},{"date":169,"type":44},"2012-01-17",{"name":50,"class":51},2,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":52},"100397010","rapid-analysis-and-response-evaluation-of-combination-anti-neoplastic-agents-in-rare-tumors-rare-cancer-trial-rare-1-nilotinib-and-paclitaxel-100397010","NCT04449549","Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel","* INCLUSION CRITERIA:\n* Patients must have histologically confirmed rare solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options exist. With Amendment G (v 6-17-24), eligibility will be limited to patients with adult granulosa cell ovarian cancer, clear cell ovarian cancer, anal cancer, or Ewing sarcoma. Patients must have measurable and evaluable disease.\n* Age \\>= 18 years.\n* ECOG performance status \\\u003C= 2.\n* Patients must have normal organ and marrow function as defined below:\n\n  * Absolute neutrophil count \\>=1,500\u002FmcL\n  * Platelets \\>=100,000\u002FmcL\n  * Total bilirubin \\\u003C=1.5 X institutional ULN\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C=3 X institutional upper limit of normal; \\\u003C= 5.0 x ULN in patients with liver metastases\n  * creatinine \\\u003C=1.5 X institutional ULN OR\n  * creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for patients with creatinine levels \\>1.5 mg\u002FdL\n* Nilotinib and paclitaxel have both been assigned to pregnancy category D by the FDA. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for at least 3 months after dosing with study drugs ceases. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of study drug administration.\n* Patients must have completed radiation therapy or major surgery \\>= 3 weeks, or biologic therapy or chemotherapy \\>= 5 half-lives or 3 weeks, whichever is shorter (6 weeks for nitrosoureas and mitomycin C) prior to entering the study. Patients must be \\>= 2 weeks since any prior administration of a study drug in a Phase 0 or equivalent study and be \\>= 1 week from palliative radiation therapy (patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the PI's discretion). Patients must have recovered to eligibility levels from prior toxicity or adverse events. Treatment with bisphosphonates is permitted.\n* Biopsies are optional on this study. In lieu of baseline biopsies, patients are encouraged to submit at registration archival tumor biopsy tissue from a previous research study or medical care providing it meets the minimum collection and preservations requirements outlined for the submission of archival tissue are:\n\n  * Tissue must have been collected within 3 months prior to registration.\n  * Patient must not have received any intervening therapy for their cancer since the collection of the tumor sample.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For these patients, an HIV viral load test must be completed within 28 days prior to enrollment.\n\nEXCLUSION CRITERIA:\n\n* QTcF interval of \\>=450 msec at study entry; congenital long QT syndrome\n* Sensory\u002Fmotor neuropathy \\>= Grade 2\n* Patients who are receiving any other investigational agents.\n* Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:\n\n  * Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:\n\n    * Evaluable or measurable disease outside the CNS\n    * No metastases to brain stem, midbrain, pons, medulla, or cerebellum\n    * No history of intracranial hemorrhage or spinal cord hemorrhage\n    * No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted.\n    * No neurosurgical resection or brain biopsy within 28 days prior to Cycle 1, Day 1\n  * Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:\n\n    * Radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and radiographic screening for the current study\n    * No stereotactic radiation or whole-brain radiation within 28 days prior to Cycle 1, Day 1\n    * Screening CNS radiographic study \\>=4 weeks from completion of radiotherapy and \\>=2 weeks from discontinuation of corticosteroids\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs.\n* Uncontrolled intercurrent illness including, but not limited to, serious untreated infection, symptomatic respiratory failure\u002Fcongestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because nilotinib and paclitaxel have been assigned to pregnancy category D by the FDA. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drugs, breastfeeding should be discontinued prior to the first dose of study drug and women should refrain from nursing throughout the treatment period and for 3 months following the last dose of study drug.",{"count":179,"type":22},82,[64],"Background:\n\nPeople with rare cancers often have limited treatment options. The biology of rare cancers is not well understood. Researchers want to find better treatments for these cancers. They want to test 2 drugs that, taken separately, have helped people with non-rare cancers. They want to see if these drugs together can make rare cancers shrink or stop growing.\n\nObjective:\n\nTo learn if nilotinib and paclitaxel will benefit people with rare cancers.\n\nEligibility:\n\nPeople age 18 and older who have a rare, advanced cancer that has progressed after receiving standard treatment, or for which no effective therapy exists.\n\nDesign:\n\nParticipants will be screened with medical history and physical exam. They will have blood and urine tests. They will have a pregnancy test if needed. They will have an electrocardiogram to check their heart. They will have imaging scans to measure their tumors.\n\nParticipants will repeat the screening tests during the study.\n\nParticipants will receive nilotinib and paclitaxel. The drugs are given in 28-day cycles. Nilotinib is a capsule taken by mouth twice a day. Paclitaxel will be given intravenously by peripheral line or central line once a week for the first 3 weeks of each cycle.\n\nParticipants will keep a medicine diary. They will track when they take the study drugs and any side effects they may have.\n\nParticipants may have optional tumor biopsies.\n\nParticipants can stay on the study until their disease gets worse or they have intolerable side effects.\n\nParticipants will have a follow-up phone call about 30 days after taking the last dose of study drugs.",[29],[184,185,186,187],"Pharmacodynamic","BCR Abl kinase inhibitor","Taxanes","Combination","2026-08-19",{"date":41,"type":44},{"date":191,"type":44},"2020-08-24",{"date":193,"type":22},"2027-04-08",{"name":50,"class":51},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":202,"targetDuration":4,"studyType":23,"phases":204,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":52},"100313872","5-aza-4-thio-2-deoxycytidine-aza-tdc-in-people-with-advanced-solid-tumors-100313872","NCT03366116","5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors","Phase I Trial of 5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in Patients With Advanced Solid Tumors","* INCLUSION CRITERIA:\n* Patients must have histologically documented solid tumors whose disease has progressed on standard therapy or for which there is no available standard therapy.\n* Age \\>=18 years of age.\n* ECOG performance status \\\u003C= 2.\n* Patients must have normal organ and marrow function as defined below:\n\n  * absolute neutrophil count \\>= 1,500\u002FmcL\n  * platelets \\>=100,000\u002FmcL\n  * total bilirubin \\\u003C=1.5 X institutional upper limit of normal (\\\u003C=3 x upper limit of normal in the presence of documented Gilbert s syndrome)\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C=3 X institutional upper limit of normal\n\nOR\n\n* AST(SGOT)\u002FALT(SGPT) \\\u003C=5 X institutional upper limit of normal for patients with liver metastases\n* creatinine \\\u003C=1.5X institutional upper limit of normal\n\nOR\n\n* creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for patients with creatinine levels above 1.5X institutional normal\n\n  * Because nucleoside analogs are known to be teratogenic, women of child-bearing potential and men must agree to use two forms of contraception (hormonal or barrier method of birth control; abstinence; sterilization) prior to study entry, for the duration of study participation, and for 3 months after completing study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use two forms of contraception prior to the study, for the duration of study participation, and for 3 months after completion of administration of Aza-TdC.\n  * Patients must have completed any chemotherapy or biologic therapy \\>= 4 weeks or 5 half-lives (whichever is shorter) (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Patients must be \\>= 2 weeks since any prior palliative radiation or cyberknife therapy. Patients must have recovered to grade 1 from prior toxicity or adverse events. Patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the PI's discretion. Patients with bone metastases or hypercalcemia on intravenous bisphosphonate treatment prior to study entry may continue this treatment.\n  * Ability to understand and the willingness to sign a written informed consent document.\n  * Willingness to provide blood and urine samples for research purposes.\n  * Ability to swallow pills\u002Fcapsules.\n  * Left ventricular ejection fraction greater than 45% or the institutional lower limit of normal by either ECHO or MUGA at entry.\n  * For patients enrolled on the expansion cohort, patients must have tumor amenable to biopsy (excisional or incision biopsies of skin or H \\& N lesions under visualization) and willingness to undergo tumor biopsies.\n\nEXCLUSION CRITERIA:\n\n* Patients who are receiving any other investigational agents.\n* Pregnant women and women who are breastfeeding are excluded from this study.\n* Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to active or uncontrolled infection, immune deficiencies, known HIV infection requiring protease inhibitor therapy, known Hepatitis B, known Hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:\n\n  * Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:\n\n    * Evaluable or measurable disease outside the CNS\n    * No metastases to brain stem, midbrain, pons, medulla, or cerebellum\n    * No history of intracranial hemorrhage or spinal cord hemorrhage\n    * No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted.\n    * No neurosurgical resection or brain biopsy within 28 days prior to Cycle 1, Day 1\n  * Patients with treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:\n\n    * No stereotactic radiation or whole-brain radiation within 14 days prior to Cycle 1, Day 1\n    * Screening CNS radiographic study 2 weeks from completion of radiotherapy and \\>=1 week from discontinuation of corticosteroids. The presence of new CNS mets will not exclude the patient but provide a baseline. If the irradiated lesion showed increased edema or growth, patient may be enrolled if asymptomatic but a repeat MRI should be done within the next 2-4 weeks for follow up.\n* Malabsorption syndrome or other conditions that would interfere with intestinal absorption.",{"count":203,"type":22},75,[25],"Background:\n\nBlood, tissue, and tumor cells contain genes. Genes are made up of DNA. DNA is the \"instruction book\" for each cell. In some people with cancer, the genes that might have slowed the growth of their tumor were \"turned off.\" Researchers want to see if a new drug can turn the genes back on and slow the tumor growth. The drug is called Aza-TdC.\n\nObjective:\n\nTo test the safety of Aza-TdC, and to find out the dose of this drug that can be safely given to humans.\n\nEligibility:\n\nPeople ages 18 and older who have advanced cancer that has gotten worse after standard treatment, or for which no effective therapy exists\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nBlood and urine tests\n\nScans to measure their tumors\n\nTest to measure the electrical activity of the heart\n\nParticipants will take the study drug by mouth. The drug is given in cycles. Each cycle is 21 days (3 weeks) long.\n\nWeek 1 and week 2: participants will take the study drug once a day for 5 days. Then they will have 2 days without the drug. Week 3: no study drug is taken. This completes one cycle of treatment.\n\nFor cycle 1, participants will repeat the screening tests several times. For all other cycles, participants will have blood tests and pregnancy tests. They will have scans of their tumor every 6 weeks.\n\nThe cycle will be repeated as long as the participant tolerates the drug and the cancer is either stable or gets better.\n\nSponsoring Institute: National Cancer Institute\n\n...",[29,207],"Solid Tumors",[209,210,211,212,213],"Pharmacodynamics","DNA Methylation","Pharmacokinetics","Nucleoside Analog","Epigenetics",{"date":41,"type":44},{"date":216,"type":44},"2018-11-05",{"date":218,"type":22},"2026-09-30",{"name":50,"class":51},{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":232,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":243},"100614190","phase-1-two-part-study-of-nenocorilant-combined-with-nivolumab-in-patients-with-advanced-solid-malignancies-100614190","NCT07276373","Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies","A Phase 1b\u002F2, Open-Label, Dose-Finding and Proof of Concept Study of Nenocorilant in Combination With Anti-Programmed Cell Death\u002F(Ligand) 1 in Patients With Advanced Solid Malignancies","Inclusion Criteria:\n\nPart 1\n\n* Signed and dated institutional review board (IRB)\u002F independent ethics committee (IEC)-approved informed consent form (ICF)\n* Has solid malignancies that have received all available standard therapies for the specific tumor type or for which no standard therapy exists, unless patient is intolerant of treatment\n* Has a life expectancy of ≥ 3 months\n* Has evaluable disease based on RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Has adequate organ function\n* Negative serum or urine pregnancy test for female patients of childbearing potential\n* Agreement to use appropriate precautions to avoid pregnancy, unless the patient and\u002For their sole sexual partner is permanently sterilized\n\nExclusion Criteria:\n\nPart 1\n\n* Past or current immune-related adverse events (irAEs) due to anti-programmed cell death protein 1 ligand 1 (PD\\[L\\]1) therapy that meet any of the following criteria:\n\n  1. Grade ≥ 3\n  2. Resulted in discontinuation of anti-PD(L)1 therapy\n* Medical history of an autoimmune or inflammatory disease requiring immunosuppressive therapy\n* Medical history of adrenal insufficiency\n* Has had any major surgery within 4 weeks prior to the first dose of study treatment\n* Concurrent treatment with mifepristone or another glucocorticoid receptor (GR) modulator\n* Unable to swallow, retain, or absorb oral medication\n* Concurrent participation in another interventional clinical trial\n* Has toxicities due to prior therapies that are reversible and have not resolved\n* Requirement for treatment with prohibited medications, including but not limited to systemic corticosteroids and cytochrome P450(CYP)3A inducers or inhibitors\n* Has a known history of severe hypersensitivity to any of the study drugs, or other human\u002Fhumanized monoclonal antibodies\n* Pregnant or lactating patients or female patients expecting to conceive children within the projected duration of the trial\n* Has clinically significant uncontrolled condition(s) which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's safety or participation\n* Known psychiatric disorder that would interfere with trial compliance\n* Has infection with HIV, hepatitis C virus, or hepatitis B virus\n* Has untreated parenchymal brain metastasis or has uncontrolled central nervous system metastases\n* Has a history of another malignancy within 2 years prior to study treatment, unless cured\n* Has received prior autologous or allogeneic organ or tissue transplantation\n* A QTcF interval \\>450 msec, a family history of long QT syndrome or unexplained sudden death at young age, or a requirement for use of medication that may prolong the QTc interval",{"count":228,"type":22},50,[25,64],"This open-label, dose-finding, and proof of concept study will evaluate the safety, tolerability, maximum-tolerated dose (MTD) and\u002For optimal dose of nenocorilant when administered in combination with nivolumab in patients with advanced solid malignancies.",[29],[233,207,234],"Advanced Solid Tumors","Solid Malignancies","2026-08-17",{"date":188,"type":44},{"date":238,"type":44},"2026-01-16",{"date":240,"type":22},"2027-01",{"name":242,"class":108},"Corcept Therapeutics",5,{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":153,"sex":251,"minAge":252,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":23,"phases":256,"briefSummary":258,"conditions":259,"keywords":263,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":275},"100524209","biennial-cem-in-women-with-a-personal-history-of-breast-cancer-100524209","NCT06105749","Biennial CEM in Women With a Personal History of Breast Cancer","Outcome of Biennial Screening Contrast-Enhanced Mammography (CEM) in Women With a Personal History of Breast Cancer (PHBC)","Inclusion Criteria:\n\n* Asymptomatic women, ages 30-79, with a personal history of breast cancer who are at least one year out from any breast cancer surgery and\u002For treatment and are scheduled to have a routine annual mammogram with tomosynthesis (DBT).\n\nExclusion Criteria:\n\n* Women with a history of prior moderate or severe iodinated contrast reaction \\[only those with a prior mild reaction that can be managed by pre-medication AND with and a strong desire to participate will be allowed to participate. However, among these women with a mild sensitivity, if they are allergic to Benadryl (one of the premedications), they will be excluded\\].\n* Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions.\n* Women who have had bilateral mastectomy\n* Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\n* Pregnancy or lactation\n* Women actively being treated for cancer of any type with chemotherapy.\n* Women with stage 4 metastasis to visceral areas or brain\n* Women with known personal history of breast cancer who have a screening breast MRI exam within 24 months prior to the current round of CEM.\n* Women with known personal history of breast cancer who had a CEM exam within the prior 23 months","FEMALE","30 Years","79 Years",{"count":255,"type":22},1600,[257],"NA","This is a prospective clinical trial that will examine if biennial contrast-enhanced mammography added to annual 3D mammography (tomosynthesis) substantially improves breast cancer detection with minimal increase in false-positives, in women with a personal history of breast cancer.",[260,261,262,29],"Breast Cancer","Breast Neoplasms","Breast Cancer Female",[264,265,266],"Breast cancer screening","Digital Breast Tomosynthesis","Contrast-Enhanced Mammogram",{"date":188,"type":44},{"date":269,"type":44},"2023-11-08",{"date":271,"type":22},"2031-04",{"name":273,"class":274},"Wendie Berg","OTHER",6,{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":283,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":285,"conditions":286,"keywords":290,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":4,"leadSponsor":302,"locationsCount":303},"100125401","collection-of-tissue-samples-for-cancer-research-100125401","NCT00900198","Collection of Tissue Samples for Cancer Research","Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)","* INCLUSION CRITERIA - ADULT:\n* Patients 18 years of age and older who are being evaluated and\u002For treated for cancer at the NIH Clinical Center or at participating sites:\n\n  * Who have a newly diagnosed malignancy for which they have not yet received treatment, or\n  * Who have a previously treated malignancy that is now recurrent or currently progressing on treatment indicated by:\n\n    * radiographic evidence of tumor growth and\u002For new metastases, or\n    * CBC w\u002Fdifferential and\u002For flow cytometry, or\n    * documented evidence by the treating physician of signs\u002Fsymptoms of clinical disease progression, or\n  * Who are currently undergoing treatment and for whom disease response has not yet been assessed,\n\n    ---In this circumstance, specimen collection should occur as distant in time from the most recent drug administration as possible such as after completion of a treatment cycle and immediately prior to initiation of the next cycle.\n  * Patients with ongoing partial response (PR) or stable disease (SD) are eligible.\n\n    * For solid tumor diagnoses, confirmation of viable malignancy and\u002For \\\u003C90% tumor necrosis, fibrosis, or hemorrhage per the final pathology must be reported to the coordinating site for patients enrolled with ongoing PR or SD at the time of specimen collection.\n    * For hematologic malignancies, confirmation of viable malignancy must be reported to the coordinating site per the final flow cytometry report.\n* Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or biologic fluid specimens used for research as outlined in this protocol.\n\nAt the NIH Clinical Center ONLY:\n\n* At the PIs discretion, specimens may be collected from patients 18 years of age and older prior to the development of an invasive cancer, who are being evaluated and\u002For treated for a confirmed familial cancer syndrome such as but not limited to Hereditary Breast and Ovarian Cancer (HBOC), Hereditary Non-polyposis Colorectal Cancer Syndrome or Hereditary Diffuse Gastric Cancer (HDGC) syndrome.\n* Specimens, including blood only, can be collected from patients 18 years of age and older who are being evaluated and\u002For treated for a hematologic malignancy, including Myelodysplastic Syndrome (MDS) and\u002For MDS Myeloproliferative Neoplasm (MDS-MPN), that meet all other adult eligibility criteria.\n\n  * Due to the different characteristics of hematologic malignancies versus solid tumor malignancies, including methodology for assessment of disease response, residual disease, and progression, evaluation of these factors for determination of protocol eligibility should be made utilizing established standards such as hematopathology, flow cytometry, immunohistochemical analysis, etc.\n\nEXCLUSION CRITERIA:\n\nNote: Testing for bloodborne pathogens or other infections is not required for eligibility assessment and will be performed only if clinically indicated. Exclusion criteria for bloodborne pathogens and\u002For other infections is based on existing documentation in the medical record or patient report of such diagnosis at the time of eligibility assessment, if testing is not obtained for clinical indications.\n\n* Patients with cancer-like syndromes and\u002For blood disorders such as but not limited to systemic mastocytosis, Langerhans cell histiocytosis, chronic eosinophilic leukemia\u002Fhypereosinophilic syndrome, lymphomatoid granulomatosis, or monoclonal gammopathy of undetermined significance (MGUS).\n* Patients with invasive fungal infections.\n* Patients with active and\u002For uncontrolled infections or who are still recovering from an infection:\n\n  * All antibiotics, antifungals, or antivirals prescribed for the treatment of an infection should be completed at least 1 week (7 days) prior to collection.\n  * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics.\n  * Patients receiving antibiotics, antifungals, or antivirals for prophylaxis are permissible.\n  * Antibiotics being administered topically at a location distant from the planned tissue collection site or eye drops for a localized infection are permissible.\n  * Note: Use of antibiotics for prophylaxis is not an exclusion.\n* Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e., quantifiable HBV-DNA and\u002For positive HbsAg, quantifiable HCV-RNA) or known history of HCV or HBV.\n* Patients with Hepatitis A as indicated by anti-HAV IgM reactivity\n\n  --Note: Patients that are anti-HAV IgG reactive only are not excluded\n* Blood only collections from patients with solid tumors or hematologic malignancy demonstrating partial or stable disease response:\n\n  * Blood will not be collected from patients whose disease demonstrates ongoing partial response or ongoing stable disease given the poor rate of model generation from such specimens.\n  * Blood will not be collected from patients between doses within a single treatment cycle.\n* Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR).\n\nINCLUSION CRITERIA - PEDIATRIC:\n\n* Patients younger than 18 years of age and older than 2 months with a histologically or cytologically confirmed diagnosis of cancer (solid tumor or hematologic malignancy) who are being treated for cancer at the NIH Clinical Center or participating clinical sites and who will already be undergoing a clinically necessary medical procedure during which tumor tissue will be resected or needle biopsy tissue or bone marrow aspirate collected. Tissue from neonates will not be collected.\n* Ability and willingness to assent to participation, utilizing an explanation that is understandable\u002Fage appropriate, as well as receiving parental permission.\n\nAt the NIH Clinical Center ONLY\n\n-At the PI s discretion, clinically indicated tissue collections may occur from patients with pediatric tumors that are generally benign but are known to undergo malignant transformation, e.g., neurofibromatosis, osteochondromas, pheochromocytoma, etc.\n\nEXCLUSION CRITERIA - PEDIATRIC:\n\nNote: Testing for bloodborne pathogens or other infections is not required for eligibility assessment and will be performed only if clinically indicated. Exclusion criteria for bloodborne pathogens and\u002For other infections is based on existing documentation in the medical record or patient report of diagnosis at the time of eligibility assessment, if testing is not obtained for clinical indications.\n\n* Patients with invasive fungal infections\n* Patients with active and\u002For uncontrolled infections or who are still recovering from an infection:\n\n  * Actively febrile patients with uncertain etiology of febrile episode\n  * All antibiotics should be completed at least 1 week (7 days) prior to collection\n  * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics\n  * Note: Use of antibiotics for prophylaxis is not an exclusion.\n* Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e., quantifiable HBV-DNA and\u002For positive HbsAg, quantifiable HCV-RNA) or known history of HCV or HBV.\n* Patients with Hepatitis A as indicated by anti-HAV IgM reactivity\n\n  --Note: Patients that are anti-HAV IgG reactive only are not excluded\n* Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR) based on imaging.\n* Blood only collections from patients with partial or stable disease response:\n\n  * Blood will not be collected from patients whose disease demonstrates ongoing partial response or ongoing stable disease given the poor rate of model generation from such specimens.\n  * Blood will not be collected from patients between doses within a single treatment cycle.","2 Months",{"count":155,"type":22},"Background:\n\n-Patients who are being evaluated and\u002For treated at the NIH Clinical Center and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens.\n\nObjectives:\n\n* To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment.\n* To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol.\n\nEligibility:\n\n-Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and\u002For treated for cancer at the NIH Clinical Center participating sites.\n\nDesign:\n\n* This is a multicenter tissue procurement protocol with NCI as the coordinating center.\n* For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocols to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Tissues and biological fluids to be procured may include but are not limited to blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol.\n* For pediatric patients: tumor biopsy\u002Fresection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits.\n* Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents\u002Fguardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture.\n* This study has two separate consent forms at the NIH Clinical Center: one for adult patients to donate specimens for ongoing research on assay development and studies of molecular pathways, and one for adult and age-appropriate pediatric patients to donate samples for the generation of preclinical models. The study also has consent form templates for adult and pediatric patients at participating sites to donate specimens to create preclinical models.\n* Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.",[29,287,288,289],"Lymphomas","Multiple Myeloma","Myelodysplastic Syndrome",[291,292,293,294,295,296],"Tissue Collection","Biospecimen","Assay Development","Tissue Acquisition","Tissue Biopsies","Natural History","2026-08-15",{"date":299,"type":44},"2026-08-18",{"date":301,"type":44},"2006-07-06",{"name":50,"class":51},17,{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":311,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":52},"100306465","sample-collection-and-tracking-for-the-developmental-therapeutics-clinic-100306465","NCT03269578","Sample Collection and Tracking for the Developmental Therapeutics Clinic","Longitudinal Sample Collection and Tracking for the Developmental Therapeutics Clinic, National Cancer Institute","* INCLUSION CRITERIA:\n* Patients who are being evaluated and\u002For treated for cancer or benign tuumors in the Developmental Therapeutics Clinic at the NIH Clinical Center\n* Ability to understand and willingness to sign a written informed consent document indicating their willingness to have data from their tissue or biologic fluid research specimens and limited medial information used for research as outlined in this protocol and to allow protocol staff access to the CRIS database and their Medical Records Number (MRN).\n* Age greater than or equal to 18 years\n\nECLUSION CRITERIA:\n\nNone",{"count":312,"type":22},3000,"Background:\n\nPeople who join a study in the Developmental Therapeutics Clinic (DTC) have tests. These include blood draws and biopsies. Researchers collect data from these samples. Some people take part in more than one study at the DTC. At this time, data are connected only with one single study. Researchers want to access people s medical records. This will allow them to link the research data from all their studies they have or will take part in. Researchers also want to collect medical data about their diagnosis and treatment history. This will allow them to see how their cancer reacted to different drugs over time.\n\nObjective:\n\nTo enter people into a master protocol to connect research sample and treatment data across DTC studies.\n\nEligibility:\n\nPeople ages 18 and older who are being evaluated or treated for cancer in the DTC\n\nDesign:\n\nParticipants will allow researchers to look at all the data from their research samples. This includes those from their current, past, and any future NIH studies.\n\nParticipants will allow researchers to access some of their medical data. This includes age, diagnosis, treatment history, and response to treatment.\n\nParticipants will provide no new samples.\n\n...",[29,315],"Lymphoma",[209,291,295,292,293,296],"2026-08-14",{"date":235,"type":44},{"date":320,"type":44},"2017-08-28",{"date":322,"type":22},"2027-05-30",{"name":50,"class":51},{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":23,"phases":333,"briefSummary":334,"conditions":335,"keywords":338,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":355},"100480315","a-self-management-based-survivorship-intervention-for-chinese-cancer-survivors-100480315","NCT05534386","A Self-management Based Survivorship Intervention for Chinese Cancer Survivors","How to Prevent Lost in Transition? - Adaptive Randomised Controlled Trial of a Self-management Based Survivorship Intervention for Chinese Cancer Survivors","Inclusion Criteria:\n\n* Cantonese- or Mandarin-speaking Chinese patients diagnosed curable cancer\n* have completed primary and adjuvant treatment within the past six months\n\nExclusion Criteria:\n\n* Patients diagnosed with metastatic cancer",{"count":332,"type":22},486,[257],"This study, using a sequential multiple assessment randomized controlled trial (SMART) approach, will evaluate a cancer survivorship care intervention on physical symptom distress, weight management, self-efficacy in managing cancer and health-related quality of life among Chinese patients recently completed curative cancer treatment.",[336,337,29],"Physical Symptom Distress","Weight Management",[339,340,341,342,343,344,345],"Physical symptom distress","Weight management","Self-efficacy in managing cancer","Health-related quality of life","Survivorship intervention","Sequential multiple assessment randomized controlled trial","psychooncology","2026-08-11",{"date":348,"type":44},"2026-08-13",{"date":350,"type":44},"2023-04-12",{"date":352,"type":22},"2027-12-31",{"name":354,"class":274},"The University of Hong Kong",7,{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":365,"briefSummary":366,"conditions":367,"keywords":368,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":52},"100622376","phase-1-phase-1-study-of-jv-394-autologous-anti-cd94-car-t-for-rr-cd94-tnk-cell-neoplasms-100622376","NCT07382817","Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r\u002Fr CD94+ T\u002FNK Cell Neoplasms","A Phase 1 Safety and Efficacy Study of JV-394 Autologous Anti-CD94 Chimeric Antigen Receptor T Cell Therapy in Patients With Relapsed or Refractory CD94+ T\u002FNK Cell Neoplasms","Inclusion Criteria:\n\n1. ≥18 years of age.\n2. Confirmed T\u002FNK cell malignancies as per local histopathological assessment.\n3. Relapsed or refractory disease after at least one line of systemic therapy or intolerant to standard therapy for their cancer.\n4. Eligible histologies include: extranodal NK\u002FTCL, hepatosplenic TCL, primary cutaneous CD8+ aggressive epidermotropic cytotoxic TCL, subcutaneous panniculitis-like TCL, monomorphic epitheliotropic intestinal TCL, enteropathy-associated TCL, primary cutaneous γδ TCL, peripheral TCL cytotoxic type, Epstein-Barr virus (EBV)+ nodal T\u002FNK cell lymphoma, and other CD94+ T\u002FNK cell malignancies not listed above.\n5. ≥50% of tumor cells are positive for CD94 by flow cytometry or IHC. Historical documentation of CD94 expression in the tumor is acceptable if available. If there is no historical documentation of CD94 expression, testing of archival tumor tissue or fresh tumor biopsy is required. Testing of archival tumor tissue may be done by IHC following a prescreening consent.\n6. At least two weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic anti-cancer therapy or 1 week from prior radiation therapy prior to leukapheresis.\n7. ECOG performance status of 0-1 (Appendix 1).\n8. For non-cutaneous lymphomas, at least one measurable lesion as per Lugano 2014 classification. Subjects with primary cutaneous variants must have at least 1 measurable lesion that is evaluable using the Olsen 2021 criteria.\n9. Toxicities due to prior therapy must be stable and recovered to ≤grade 1 (except for clinically non-significant toxicities such as alopecia).\n10. Absolute neutrophil count of ≥1.0×109 \u002FL.\n11. Absolute lymphocyte count of ≥0.1×109 \u002FL.\n12. Platelet count of ≥75×109 \u002FL.\n13. Creatinine clearance (as estimated by Cockcroft Gault) ≥45 mL\u002Fmin.\n14. Serum alanine transaminase (ALT) \u002F aspartate transaminase (AST) ≤5 times the upper limit of normal (ULN).\n15. Total bilirubin ≤2 mg\u002FdL, except in patients with Gilbert's syndrome.\n16. Cardiac ejection fraction ≥45% with no evidence of clinically significant pericardial effusion.\n17. Baseline oxygen saturation ≥92% on room air.\n18. Women of childbearing potential must have a negative serum or urine pregnancy test (women who have had hysterectomy and women who are over the age of 45 years and have not had a menstrual period for at least 1 year are not considered to be of childbearing potential).\n\nExclusion Criteria:\n\n1. Subjects with aggressive NK cell leukemia and indolent T\u002FNK cell malignancies such as TLGL or NK-LGL.\n2. Patients with tumor cells in the peripheral blood ≥1% of lymphocytes as determined by flow cytometry.\n3. Active central nervous system (CNS) lymphoma including patients with detectable cerebrospinal fluid malignant cells or brain metastases. Patients with prior CNS lymphoma that has been effectively treated will be eligible if treatment was completed at least one year prior to enrolment and there is no evidence of disease on MRI with gadolinium contrast at the time of screening.\n4. Autologous stem cell transplantation within 6 weeks.\n5. Allogeneic cell transplantation within 3 months or active graft versus host disease.\n6. History of any form of primary immunodeficiency that in the opinion of the investigator may affect efficacy of the CAR T product.\n7. History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease.\n8. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 2 years and treated with curative intent. Patients with a prior history of malignancy whose natural history or treatment (e.g. hormonal therapy) does not have the potential to interfere with either the safety or efficacy assessment of the investigational regimen in the opinion of the investigator may be included.\n9. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management. Simple urinary tract infection and uncomplicated bacterial pharyngitis or localized skin infections are permitted if responding to active treatment and after consultation with the Principal Investigator.\n10. Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and\u002For nucleic acid testing.\n11. Active autoimmune (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or inflammatory disease (including graft-versus-host disease) requiring systemic immunosuppressive therapy. Physiological replacement of corticosteroids of up to 7.5 mg of prednisone or equivalent per day, and topical and inhaled corticosteroids are permitted.\n12. History or presence of CNS disorders such as seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.\n13. Patients with cardiac atrial or cardiac ventricular lymphoma involvement.\n14. Requirement for urgent therapy due to tumor mass effect such as bowel obstruction or blood vessel compression.\n15. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment.\n16. Live vaccine ≤6 weeks prior to planned start of conditioning regimen.\n17. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the conditioning chemotherapy on the fetus or infant.\n18. Females of childbearing potential and males of child fathering potential who are not willing to practice two methods of birth control from the time of consent through 6 months after infusion of the study drug.\n19. In the investigator's judgment, the patient is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.\n20. Patients who are receiving any other investigational agents.",{"count":364,"type":22},33,[25],"The goal of this clinical research study is to find the highest tolerable dose of JV-394 (a type of autologous CAR-T cell therapy) that can be given to patients who have T\u002FNK cell lymphoma that is relapsed or refractory. The safety and possible side effects of JV-394 will also be studied.",[29],[138,369,370],"T Cell Lymphoma","T\u002FNK-Cell Lymphoma","2026-08-10",{"date":373,"type":44},"2026-08-12",{"date":375,"type":44},"2026-02-18",{"date":377,"type":22},"2031-12-09",{"name":379,"class":274},"M.D. Anderson Cancer Center",{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":23,"phases":390,"briefSummary":391,"conditions":392,"keywords":394,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":52},"100648578","simulation-based-patient-education-to-adress-radiotherapy-related-anxiety-in-cancer-patients-araise-100648578","NCT07721246","Simulation-Based Patient Education to Address Radiotherapy-Related Anxiety in Cancer Patients (ARAISE)","Addressing Radiotherapy Anxiety Through Immersive Simulation and Education: Effects of a Simulation-Based Patient Education Intervention on Psychosocial Burden in Cancer Patients Receiving Radiotherapy (ARAISE)","ARAISE","Inclusion Criteria:\n\n* Age 18 years or older\n* Histologically or cytologically confirmed malignant tumor disease\n* Stage I - III (UICC TNM classification)\n* ECOG performance status ≤ 2\n* Curative-intent external beam radiotherapy regimen with at least 5 fractions\n* First course of radiotherapy\n* Able to independently operate the electronic data collection instrument\n* Written informed consent after study information\n* Sufficient German language proficiency to read and complete the study questionnaires independently and without translation assistance\n\nExclusion Criteria:\n\n* Lack of capacity to provide informed consent\n* Pregnancy or breastfeeding\n* Stereotactic radiotherapy\n* Emergency treatment indication\n* Acute suicidality, acute psychosis, or other acute psychiatric disorder\n* Initiation of or dose change in psychotropic medication within 4 weeks before baseline (T0)\n* Cognitive impairment that precludes independent completion of the questionnaires\n* Visual or auditory impairment that prevents perception of the on-screen or audio content despite available aids",{"count":389,"type":22},144,[257],"For the majority of cancer patients, radiotherapy is a crucial component of their treatment process. However, many patients experience anxiety before or during radiotherapy. This anxiety may be related not only to the cancer diagnosis and its prognosis but also to unfamiliar aspects of the treatment process, the equipment, and the treatment environment. General or non-specific feelings of anxiety may also become associated with the radiotherapy setting, even when patients are not able to identify a specific treatment-related concern. Uncertainty about what will happen during treatment sessions can further increase anxiety and may affect patients' overall well-being. The ARAISE project consists of two consecutive parts. In the first part, health care professionals from different disciplines and patient representatives take part in a Delphi consensus process to identify and prioritize the treatment-specific fears of patients receiving radiotherapy. The results of this first part are used to define the content of the education session that is tested in the second part. The second part is a randomized controlled study in patients receiving radiotherapy for cancer. Participants will be assigned by chance, in equal numbers, to one of two groups. All participants will receive the usual patient education provided before radiotherapy. In addition, participants in one group will receive a single immersive, simulation-based education session after the planning CT scan and before the start of treatment. The main question is whether the additional session leads to lower state anxiety at the first radiotherapy fraction compared with usual patient education alone. The study also compares state anxiety at other time points, health-related quality of life, and how well informed participants feel about their treatment. Finally, the study assesses whether the additional education session is feasible, well accepted, and practical to provide as part of routine radiotherapy care.",[29,393],"Anxiety",[395,396,397,398,399,400,401],"Radiotherapy","State-Trait Anxiety Inventory","Patient Education","Simulation Training","Quality of Life","VERT","Psycho-Oncology","2026-08-06",{"date":346,"type":44},{"date":405,"type":22},"2028-01",{"date":407,"type":22},"2030-12",{"name":409,"class":274},"University Medical Center Goettingen",{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":12,"sex":17,"minAge":418,"maxAge":419,"enrollmentInfo":420,"targetDuration":4,"studyType":23,"phases":422,"briefSummary":423,"conditions":424,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":434},"100516090","phase-2-a-master-protocol-ly900023-that-includes-several-clinical-trials-of-drugs-for-children-and-young-adults-with-cancer-100516090","NCT05999994","A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer","CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Research","CAMPFIRE","Inclusion Criteria:\n\nParticipants must meet all of the inclusion criteria below. Additional criteria are specified in the protocol amendment (individual addenda) to which the participant will enroll.\n\n* Have either measurable or evaluable disease using standard techniques by the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).\n* The participant has a Lansky (\\\u003C16 years of age) or Karnofsky (≥16 years of age) performance score of at least 50.\n* Participants must have discontinued all previous treatments for cancer or investigational agents greater than or equal to (≥)7 days after the last dose and must have recovered from clinically significant side effects.\n* The participant has adequate hematologic and organ function.\n* Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to first dose.\n* Both female and male participants of childbearing potential must agree to use highly effective contraceptive precautions during the trial and for at least 3 months following the last dose of study drug.\n\nParticipants will be ineligible if they meet any of the exclusion criteria below. Additional criteria are specified in the protocol amendment to which the participant will enroll.\n\n* Participants with severe and\u002For uncontrolled concurrent medical disease or psychiatric illness\u002Fsocial situation that, in the opinion of the investigator, could cause unacceptable safety risks or compromise compliance with the protocol.\n* Participants who have active infections requiring therapy.\n* Participants who have had allogeneic bone marrow or solid organ transplant.\n* Participants who have had, or are planning to have, certain invasive procedures.\n* Female participants who are pregnant or breastfeeding.","1 Year","39 Years",{"count":421,"type":22},105,[64],"The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug\u002Fdisease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts.",[29,425,426],"Child","Adolescent",{"date":428,"type":44},"2026-08-07",{"date":430,"type":44},"2020-01-22",{"date":432,"type":22},"2027-05",{"name":107,"class":108},72,{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":23,"phases":445,"briefSummary":446,"conditions":447,"keywords":458,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":486,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":493},"100484789","phase-1-a-study-of-a-selective-t-cell-receptor-tcr-targeting-bifunctional-antibody-fusion-molecule-star0602-in-participants-with-advanced-solid-tumors-100484789","NCT05592626","A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors","A Phase 1\u002F2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects With Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)","START-001","Inclusion Criteria:\n\n1. Participants must have histologically confirmed solid tumors that are unresectable, locally advanced, or metastatic and for which standard curative therapies do not exist or are no longer effective or have intolerable toxicities. Participants should not have received more than three regimens of prior therapies for their advanced or metastatic diseases. For Phase 2 Cohorts 8 and 10 (see below), participants should not have received more than one line of prior therapy.\n2. For Phase 1, participants must have one of the following solid tumors:\n\n   1. High mutational burden (TMB-H)\n   2. Microsatellite Instability (MSI-H)\u002FDNA mismatch repair (dMMR)\n   3. Virally associated tumors\n   4. Solid tumors generally considered as immunogenic (e.g., melanoma and renal cell carcinoma) are eligible without prior testing for TMB, MSI or viral status after the Sponsor's approval.\n3. For Phase 2, participants must have one of the following solid tumors:\n\n   1. TMB-H (not enrolling)\n   2. MSI-H\u002FdMMR (not enrolling)\n   3. CRC (both Ras wild type and mutant) (not enrolling)\n   4. NSCLC (recurrent or Primary Stage 4)\n   5. CRC with pMMR\u002FMSS (without TMB-H requirement)\n\n   (Other tumor histologies may also be included in Phase 2 as additional data emerge to support their inclusion.)\n4. Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:\n\n   * No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids \\> 10 mg prednisone\u002Fday or equivalent);\n   * No concurrent leptomeningeal disease or cord compression.\n5. Subjects who have previously received a CPI (e.g., anti-PD-L1, anti-PD-1, anti CTLA 4) prior to enrollment must have CPI immune-related toxicity resolved to either Grade ≤ 1 or baseline (prior to the CPI) to be eligible for enrollment.\n\n   * Subjects who experienced previous CPI-related endocrine abnormalities are eligible for the study regardless of CTCAE grade if well controlled on replacement therapy.\n   * Subjects who have had previous CPI-related Grade 3 to 4 pneumonitis, peri\u002Fmyocarditis, colitis and bowel perforation, myositis, encephalitis, or peripheral neuropathy will need Sponsor approval.\n\nExclusion Criteria:\n\n1. Participants with a history of known autoimmune disease with exceptions of:\n\n   * Vitiligo;\n   * Psoriasis, atopic dermatitis or other autoimmune skin condition not requiring systemic treatment;\n   * History of Graves' disease, now euthyroid for \\> 4 weeks;\n   * Hypothyroidism managed by thyroid replacement;\n   * Alopecia;\n   * Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs.\n   * Adrenal insufficiency well controlled on replacement therapy.\n2. Major surgery or traumatic injury within 8 weeks before first dose of study drug.\n3. Unhealed wounds from surgery or injury.\n4. Treatment with \\>10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for patients who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.\n5. Prior therapy within the following timeframe before planned infusion of STAR0602 as follows:\n\n   * Cytotoxic chemotherapy, small molecule inhibitors, radiation, interventional radiology procedure, or similar investigational therapies within ≤ 2 weeks or participants who have not recovered (i.e., ≤ Grade 1 or to baseline) from AEs due to a previously administered agent;\n   * Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar investigational therapies within 6 weeks prior to the initiation of study drug or participants who have not recovered (i.e., ≤ Grade 1 or to baseline) from AEs due to agents administered more than 4 weeks earlier. Note: Participants with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study.\n6. Clinically significant cardiovascular\u002Fvascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises\n7. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.\n8. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.\n9. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.\n10. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas.\n11. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation).\n12. Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.\n13. Bulky disease defined as any lesion ≥ 5 cm in greatest dimension unless approved by the Sponsor.",{"count":444,"type":22},366,[25,64],"This is an open label, multicenter, phase 1\u002F2 study to assess the safety\u002Ftolerability and preliminary clinical activity of STAR0602 as a single agent and in combination with chemotherapy administered intravenously in participants with advanced solid tumors that are antigen-rich.",[233,448,449,450,451,452,453,69,29,454,455,456,457,36],"Genital Neoplasm, Female","Urogenital Neoplasms","Lung Neoplasm","Neoplasms by Site","Papillomavirus Infection","Epstein-Barr Virus Infections","Vulvar Neoplasms","Vulvar Diseases","Abdominal Neoplasm","NSCLC (Non-small Cell Lung Cancer)",[233,459,460,461,462,463,464,465,466,467,468,469,470,471,472,473,474,475,476,477,478,479,480,36,481,482,483,133,484,485],"STAR0602","Intravenous","Antineoplastic Agents","T Cell Receptor-targeting","Bifunctional Antibody-Fusion","Specific T Cell Activator","Tumor Mutational Burden (TMB) High","Microsatellite Instability (MSI) High","Virally Associated Malignancies","Checkpoint Inhibitor Resistance","Immunotherapy","Immune Checkpoint Inhibitor Resistance","Head and Neck Cancer","Nasopharyngeal Cancer","Non-small Cell Lung Cancer","Small Cell Lung Cancer","Biliary Cancer","Melanoma","Merkel Cell Carcinoma","Skin Squamous Cell Carcinoma","Skin Basal Cell Carcinoma","Endometrial Cancer","Small Bowel Cancer","Cervical Cancer","Gastrointestinal Neoplasms","Esophageal Cancer","Bladder Cancer",{"date":346,"type":44},{"date":488,"type":44},"2023-01-04",{"date":490,"type":22},"2027-09",{"name":492,"class":108},"Marengo Therapeutics, Inc.",19,{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":153,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":23,"phases":503,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":512,"locationsCount":275},"100612842","phase-1-a-study-of-18fly4214835-in-healthy-volunteers-and-participants-with-cancer-100612842","NCT07258836","A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer","A Phase 1, Open-Label Study to Evaluate the Safety, Biodistribution, Imaging Characteristics, and Radiation Dosimetry of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer","Inclusion Criteria:\n\n* Cohort 1\n\n  * Have a radiologically, cytologically, or histologically confirmed diagnosis of cancer\n  * Are treatment-naïve to a systemic cancer therapy, OR have a documented disease progression on standard-of-care treatment (for example, failure of chemotherapy, targeted therapy or immunotherapy)\n  * Have at least 1 imageable tumor that is 15 millimeter (mm) or larger in the longest diameter\n* Cohort 2\n\n  * Are overtly healthy at the Screening Visit and upon reporting to the clinic for the positron emission tomography (PET) Imaging Visit, as determined by medical evaluation including updated medical history, vital signs, physical examination, laboratory tests, and electrocardiogram (ECG)\n\nExclusion Criteria:\n\n* Are pregnant or intend to become pregnant during their participation in the study\n* Are breastfeeding or intending to breastfeed during their participation in the study\n* Have a history of risk factors for Torsades de Pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome)\n* Are actively receiving cancer therapy or are in between cycles of treatment\n* Have a marked baseline prolongation of QT\u002Fcorrected QT interval (QTc) interval (for example, repeated demonstration of a QTc interval greater than (\\>) 450 millisecond (ms)",{"count":502,"type":22},41,[25],"The purpose of the study is to check how safe and well-tolerated \\[18F\\]LY4214835 injection is in healthy participants and participants with cancer. The study drug will be administered intravenously (IV) (into a vein). Participation in the study will last approximately 35 days.",[29,506],"Healthy","2026-08-05",{"date":402,"type":44},{"date":510,"type":44},"2025-12-22",{"date":240,"type":22},{"name":107,"class":108},{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":23,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":531,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":538},"100468924","phase-1-study-of-abemaciclib-and-elacestrant-in-participants-with-brain-metastasis-due-to-erher-2--breast-cancer-100468924","NCT05386108","Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+\u002FHER-2- Breast Cancer","An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer","ELECTRA","Inclusion Criteria:\n\n1. Participant has the signed informed consent form before any study-related activities according to local guidelines.\n2. Women or men aged ≥18 years, at the time of informed consent signature.\n\n   * Female participants may be either postmenopausal or pre\u002Fperimenopausal. Postmenopausal status is defined by:\n\n     1. Age ≥60 years\n     2. Age \\\u003C60 years and amenorrhea for 12 or more months without an alternative cause) and follicle stimulating hormone and estradiol in postmenopausal ranges per local reference ranges\n     3. Documentation of prior bilateral oophorectomy, at least 1 month before first dose of trial therapy).\n   * Pre-menopausal \u002F peri-menopausal women and men must be concurrently receiving a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 3-4 weeks before the start of trial therapy and is planning to continue LHRH during the study.\n3. Participant must have ER-positive, HER-2 negative tumor status as confirmed by local laboratory testing in the following manner:\n\n   * Documentation of ER positive tumor with ≥ 1% staining by immunohistochemistry (IHC) as defined in the 2010 or 2020 American Society for Clinical Oncology (ASCO) recommendations for ER testing, with or without progesterone receptor (PGR) positivity\n   * HER-2 negative tumor with an IHC result of 0 or 1+ for cellular membrane protein expression or an in situ hybridization negative result as defined in the 2013 or 2018 ASCO recommendations for HER-2 testing\n4. In Phase 2, participants must have at least one active and measurable brain metastasis per RECIST version 1.1.\n\n   * Any of the following qualifies brain metastases as active:\n\n     1. Newly diagnosed brain metastasis in participants who never received prior central nervous system (CNS)-directed therapy.\n     2. Newly diagnosed brain metastasis outside any area that was previously subjected to CNS-directed therapy.\n     3. Brain metastases demonstrating unequivocal progression in the opinion of the treating investigator in an area that has previously been subjected to CNS-directed therapy.\n   * For lesions, including brain metastases, to qualify as measurable, and possibly be selected as target lesions, per RECIST version 1.1, the longest diameter must be ≥10 millimeters \\[mm\\] by computed tomography \\[CT\\] or magnetic resonance imaging \\[MRI\\]).\n   * In Phase 1b, the presence of brain metastases is allowed but not required for eligibility, in this case, at least 1 measurable lesion outside the brain is required.\n5. Participants receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 7 days prior to baseline and not receiving doses higher than 4 mg of dexamethasone per day or equivalent.\n6. Participants have experienced no more than one seizure within 4 weeks prior to starting trial therapy.\n7. Participants' prior therapy received in the metastatic setting includes:\n\n   * At least one endocrine therapy\n   * Up to two chemotherapy regimens\n   * Up to two lines of prior cyclin-dependent kinase (CDK) 4\u002F6 inhibitor, not including abemaciclib\n\n   Note 1: Toxicity from prior therapy must be resolved to NCI CTCAE version 5.0 Grade ≤1, with the exception of alopecia and peripheral sensory neuropathy (Grade ≤2).\n\n   Note 2: Chemotherapy refers to not targeted cytotoxic agents (for example, alkylating agents, taxanes, nucleotide analogs, platinum-based drugs, vinca alkaloids, etc) and antibody drug conjugates (ADCs). Targeted therapies (for example, kinase inhibitors) are not considered chemotherapy for eligibility purposes. Not targeted cytotoxic agents administered for less than 1 cycle will not be counted as a prior chemotherapy regimen.\n8. Participant has documented intracranial and\u002For extracranial radiological progression or recurrence while on or after the most recent therapy.\n9. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2\n10. Participant has a life expectancy ≥ 12 weeks.\n11. Participant has adequate bone marrow and organ function, as defined by the following laboratory values:\n\n    1. Absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002Fliter (L)\n    2. Platelets ≥100 × 10\\^9\u002FL\n    3. Hemoglobin ≥9.0 grams (g)\u002Fdeciliter (dL)\n    4. Potassium, sodium, calcium (corrected for serum albumin) and magnesium CTCAE Grade ≤1 (if screening assessments are abnormal, these assessments may be repeated up to 2 times; participants may receive appropriate supplementation or treatment prior to reassessment)\n    5. Creatinine clearance (per Cockcroft-Gault formula) ≥50 mL\u002Fminute\n    6. Serum albumin ≥3.0 g\u002FdL (≥30 g\u002FL)\n    7. Liver function tests:\n\n       In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN). If the participant has liver metastases, ALT and AST ≤5.0 × ULN.\n    8. Total serum bilirubin \\\u003C1.5 × ULN except for participants with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN\n12. The participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n1. Immediate CNS-specific treatment is likely to be required, per the treating physician's assessment.\n2. Participant has imminent organ failure and\u002For visceral crisis.\n3. Participant has leptomeningeal metastases, defined as having positive cerebrospinal fluid (CSF) cytology or unequivocal radiologic and clinical evidence of leptomeningeal involvement. Note: Discrete dural metastases are permitted.\n4. Breast cancer treatment-naïve participants (that is, not having received any systemic therapy) in the advanced\u002Fmetastatic setting.\n5. History of pulmonary embolism (PE), cardiovascular accident (CVA), myocardial infarction (MI) in the past 6 months from screening visit.\n6. Prior therapy with abemaciclib in the metastatic setting. Note: Use of abemaciclib in the adjuvant setting is allowed if the last treatment administration was more than 12 months prior to first recurrence.\n7. Prior therapy with elacestrant or other investigational selective estrogen receptor degraders (SERDs), or investigational alike agents such as selective estrogen receptor modulators (SERMs), selective estrogen receptor covalent antagonists (SERCANs), complete estrogen receptor antagonists (CERANs), and proteolysistargeting chimeras (PROTACs) in the metastatic setting.\n8. Participant has a concurrent malignancy or malignancy within 3 years of enrollment, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or second primary breast cancer; and any other malignancy that is considered in complete remission by the Investigator(s) that is approved by the Medical Monitor.\n9. Currently participating in another breast cancer intervention clinical study. Participants who are being followed for overall survival for another clinical trial with no therapy and study intervention are allowed after the washout period for any prior therapy.\n10. Prior anti-cancer or investigational drug treatment within the following windows:\n\n    * Fulvestrant treatment (last injection) \\\u003C42 days before first dose of study drug\n    * Any other endocrine therapy \\\u003C14 days before first dose of study drug. Note: LHRH agonists should not be counted as endocrine therapy.\n    * Chemotherapy or other anti-cancer therapy \\\u003C14 days before first dose of study drug\n    * Any investigational anti-cancer drug therapy within \\\u003C28 days or \\\u003C5 half lives, whichever is shorter\n    * Bisphosphonates or receptor activator of nuclear factor-κB ligand (RANKL) inhibitors initiated, or dose changed \\\u003C1 month prior to first dose of study drug according to institutional guidelines.\n11. Radiation therapy (including CNS directed) within 7 days before the first dose of study drug or without a full recovery from radiotherapy acute effects.\n12. Uncontrolled significant active infections\n\n    * Participants with hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV) infection must have undetectable viral load (or detected below the lower limit of quantification) during screening\n    * Participants known to be human immunodeficiency virus positive (HIV+) are allowed as long as they have undetectable viral load (viral suppression) at baseline.\n13. Major surgery within 4 weeks of starting trial therapy.\n14. Inability to take oral medication, or history of malabsorption syndrome or any other uncontrolled gastrointestinal condition that may significantly alter the absorption of study drugs.\n15. Females of childbearing potential who do not agree to use a highly effective non-hormonal method of contraception and to abstain from donating ova within 28 days of the first dose of study treatment through 120 days after the last dose of study treatment. Highly effective non-hormonal method of contraception includes any of the following:\n\n    1. Intrauterine device (non-hormonal)\n    2. Sexual abstinence\n    3. Bilateral tubal occlusion\u002Fligation\n    4. Have a vasectomized partner with confirmed azoospermia.\n16. Male participants (including males after a vasectomy) with a pregnant or non-pregnant female of childbearing potential partner who do not agree to use a highly effective barrier contraception method (condoms) within 28 days of the first dose of study treatment until 120 days of the last dose of study treatment. And male participants who do not agree to abstain from freezing or donating sperm within the same period. In addition, female partners of childbearing potential, of male participants (who has not undergone vasectomy) must use highly effective methods of contraception.\n17. Females who are pregnant or breastfeeding. Females should not get pregnant during study treatment and for 120 days after last dose of study treatment. Females should not breastfeed during administration of elacestrant and for 1 week after receiving the last dose.\n18. Known intolerance to either study drug or any of their excipients.\n19. Participants currently receiving or received any of the following medications prior to first dose of trial therapy:\n\n    1. Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 (including foods and herbal preparations) within 14 days or \\\u003C5 half-lives, whichever is shorter)\n    2. Herbal preparations\u002Fmedications (which are not strong or moderate inducers or inhibitors of CYP3A4). These include, but are not limited to, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng within 7 days prior to initiating trial therapy\n    3. Vaccination, including but not limited to vaccination against coronavirus disease-19 (COVID-19), during the 7 days prior to randomization.\n20. Any severe medical or psychiatric condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.",{"count":522,"type":22},73,[25,64],"This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose (RP2D) and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in participants with active brain metastases from ER-positive, HER-2 negative breast cancer.",[261,526,451,29,527,528,529,530],"Brain Neoplasms","Breast Diseases","Central Nervous System Neoplasms","Brain Diseases","Central Nervous System Diseases",{"date":402,"type":44},{"date":533,"type":44},"2022-08-31",{"date":535,"type":22},"2026-12",{"name":537,"class":108},"Stemline Therapeutics, Inc.",86,{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":17,"minAge":547,"maxAge":19,"enrollmentInfo":548,"targetDuration":4,"studyType":23,"phases":550,"briefSummary":551,"conditions":552,"keywords":554,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":171},"100650131","effectiveness-and-implementation-of-supportive-and-palliative-care-review-kit-in-locations-everywhere-100650131","NCT07745816","Effectiveness and Implementation of 'Supportive and Palliative Care Review Kit in Locations Everywhere'","Effectiveness and Implementation of 'Supportive and Palliative cAre Review Kit in Locations Everywhere' (SPARKLE-2) - A Randomized Controlled Trial","SPARKLE-2","Inclusion Criteria:\n\n* Inclusion criteria for patients:\n\n  1. 21 years old or older\n  2. Diagnosed of advanced cancer diagnosis, defined as metastatic or recurrent\u002F progressive Stage III\u002FIV solid tumour\n  3. Has an unplanned hospital admission and expected to be discharged home\n  4. Able to speak English or Mandarin Chinese or Malay\n  5. Able to provide informed consent\n\n     Additional inclusion criteria for patient participants of semi-structured interviews are:\n  6. Enrolled in the SPARKLE-2 RCT, whether randomized to the SPARKLE intervention or usual care group and regardless of fidelity to trial procedures.\n* Inclusion criteria for caregivers:\n\n  1. 21 years old or older\n  2. Self-endorsing or identified by an enrolled patient as a spouse\u002Fpartner, relative or friend who knows them well and who provides support due to their cancer\n  3. Able to speak English or Mandarin Chinese or Malay\n  4. Able to provide informed consent\n* Inclusion criteria for healthcare providers:\n\n  1. 21 years old or older\n  2. Healthcare professional who is involved in the clinical care of patients with advanced cancer for at least 50% of their work hours\n  3. Able to provide informed consent\n  4. Involved in the processes of the SPARKLE-2\n\nExclusion Criteria:\n\n* Exclusion criteria for patients:\n\n  1. Assessed by the treating physician as unable to complete study procedures\n  2. Unable to complete patient-reported outcome measures\n* Exclusion criteria for caregivers:\n\n  1\\. Unable to complete interviews\n* Exclusion criteria for healthcare providers:\n\n  1. Healthcare professionals that are not providing care for cancer patients.\n  2. Unable to complete interviews","21 Years",{"count":549,"type":22},300,[257],"Advanced cancer patients often experience significant physical and emotional symptoms, which can lead to frequent hospital visits and reduced quality of life. Although palliative care can help manage these symptoms and improve well-being, it is often introduced too late.\n\nA proactive symptom monitoring model, SPARKLE-2 aims to identify patients who need palliative care earlier by regularly checking their symptoms using a simple questionnaire. Patients with concerned symptoms will receive timely support from the palliative care team, with the goal of improving their quality of life, reducing unnecessary hospital admissions, and helping more patients receive care in the community rather than in hospital. In the earlier SPARKLE-1 study, it showed the improvement of patients' physical wellbeing. SPARKLE-2 seeks to test the effectiveness among advanced cancer patients with unplanned hospital visits while simultaneously collecting data on real-world implementation.",[29,553],"Palliative Care",[545],"2026-07-30",{"date":557,"type":44},"2026-08-04",{"date":559,"type":22},"2026-08-01",{"date":561,"type":22},"2029-03-31",{"name":563,"class":274},"National Cancer Centre, Singapore",{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":23,"phases":573,"briefSummary":574,"conditions":575,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":584},"100527622","phase-1-a-study-of-jnj-88549968-for-the-treatment-of-calreticulin-calr-mutated-myeloproliferative-neoplasms-100527622","NCT06150157","A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms","A First-in-Human Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-88549968, a T-cell Redirecting Bispecific Antibody for CALR-mutated Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Be greater than or equal to (\\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever the greater) at the time of informed consent\n* Positive for a calreticulin (CALR) driver mutation of essential thrombocythemia (ET) or myelofibrosis (MF)\n* Participants with ET and MF with risk characteristics as described in the protocol\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of less than or equal to (\\\u003C=) 2\n* For US sites: Eligible for ruxolitinib therapy as per drug label for participants naive to a janus kinase (JAK) inhibitor\n\nExclusion Criteria:\n\n* Known allergies, hypersensitivity, or intolerance to the excipients of the study treatment\n* Concurrent or recently diagnosed or treated malignancies present at the time of participant screening. Exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix, and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of first dose of study treatment in the opinion of both the investigator and sponsor's medical monitor. Participants cured of another malignant disease with no sign of relapse greater than or equal to (\\>=) 3 years after treatment ended are allowed to enter the study\n* Prior solid organ transplantation\n* Either of the following regarding hematopoietic stem cell transplantation:\n\n  1. Prior treatment with allogenic stem cell transplant less than or equal to (\\\u003C=) 6 months before the first dose of JNJ-88549968 or\n  2. Evidence of graft versus host disease (GVHD) that requires immunosuppressant therapy\n* History of clinically significant cardiovascular disease within 6 months prior to the first dose of study treatment",{"count":572,"type":22},241,[25],"The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D\\[s\\]) and optimal dosing schedule(s) of JNJ-88549968 in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s) in part 2 (Cohort Expansion). For U.S. sites: the purpose of this study is to characterize the safety and to determine the RP2D(s) and optimal dosing schedule(s) of JNJ-88549968 in Part 1 and part 1b (Dose Escalation), and to characterize the safety of JNJ-88549968 at the RP2D(s) in Part 2 and part 2b (Cohort Expansion), when given as monotherapy in essential thrombocythemia (ET) or myelofibrosis (MF), and with ruxolitinib or momelotinib in MF only.",[29],{"date":577,"type":44},"2026-07-31",{"date":579,"type":44},"2023-12-20",{"date":581,"type":22},"2028-06-14",{"name":583,"class":108},"Janssen Research & Development, LLC",39,{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":591,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":593,"enrollmentInfo":594,"targetDuration":596,"studyType":156,"phases":4,"briefSummary":597,"conditions":598,"keywords":599,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":243},"100419822","health-effects-of-cardiac-fluoroscopy-and-modern-radiotherapy-in-pediatrics---radiotherapy-100419822","NCT04746729","Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy","Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy (HARMONIC-RT)","HARMONIC-RT","Retrospective inclusion of study participants\n\nInclusion Criteria:\n\n* First external beam radiation therapy (EBRT) started in 2000 or after for management of a first primary neoplasm\n* Age under 22 years at the time of first EBRT initiation\n* Radiation treatment plan (first EBRT) stored in DICOM format\n* Usual residency in the country of EBRT to enable a long-term follow-up\n\nExclusion Criteria:\n\n* Patients with poor prognosis (e.g. diffuse pontine glioma or high grade glioma) at first EBRT initiation\n* Prior external or internal radiation therapy\n* Patients who refused to participate in the study\n\nProspective inclusion of study participants\n\nInclusion Criteria:\n\n* Scheduled first EBRT for management of a first primary neoplasm\n* Age under 22 years at the time of scheduled first EBRT\n* Radiation treatment plan stored in DICOM format\n* Affiliate or beneficiary of health insurance (or any required equivalent as defined in applicable national law)\n* Usual residency in the country of EBRT to enable a long-term follow-up\n* Signed informed consent\u002Fassent\n\nExclusion Criteria:\n\n* Patients with poor prognosis (e.g. diffuse pontine glioma or high grade glioma)\n* Prior external or internal radiation therapy;\n* Protected adults (persons under curatorship, tutorship \u002F individuals under guardianship by court order, persons deprived of their liberty)\n* Adult\u002Fparent(s)\u002Flegal representative(s) who cannot read or understand the informed consent in the applicable language(s) in the country of EBRT","22 Years",{"count":595,"type":22},2670,"20 Years","The goal of the HARMONIC-RT study is to evaluate late health and social outcomes of contemporary techniques of external beam radiotherapy in paediatric patients, based on the setting-up of a European, long-term registry complemented by a biobank.",[29],[395,600,601,602,603,604,605,606,607,608,609,610,611,612,613],"Oncology","Paediatrics","Late toxicities","Radiation-induced neoplasms","Radiation-induced vascular damages","Radiation-induced cardiac damages","Radiation-induced endocrine damages","Quality of life","Social outcomes","External beam radiotherapy","Photon therapy","Proton therapy","Cohort","Registry",{"date":615,"type":44},"2026-08-03",{"date":617,"type":44},"2021-01-11",{"date":619,"type":22},"2042-01-02",{"name":621,"class":622},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":630,"targetDuration":4,"studyType":23,"phases":632,"briefSummary":634,"conditions":635,"keywords":636,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":648},"100319210","phase-2-long-term-follow-up-protocol-for-participants-treated-with-gene-modified-t-cells-100319210","NCT03435796","Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells","Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells","Inclusion Criteria:\n\n* Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored, Juno Therapeutics, other affiliates of BMS, or Celgene alliance partner-sponsored trial, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.\n* Must understand and voluntarily sign an Informed Consent Form\u002FInformed Assent Form prior to any study-related assessments\u002Fprocedures being conducted.\n\nExclusion Criteria:\n\nNot Applicable\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply",{"count":631,"type":22},1541,[64,633],"PHASE3","This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.\n\nParticipants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.",[29],[637,638,639],"Long-term follow up","Gene-Modified T Cells","CAR T Cell","2026-07-29",{"date":555,"type":44},{"date":643,"type":44},"2018-07-19",{"date":645,"type":22},"2036-11-30",{"name":647,"class":108},"Celgene",209,{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":655,"eligibilityCriteria":656,"healthyVolunteers":153,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":657,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":659,"conditions":660,"keywords":667,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":684,"locationsCount":52},"100649958","methylation-profile-test-methylscape-in-body-fluids-for-multi-cancer-detection-and-monitoring-in-colombia-100649958","NCT07741435","Methylation Profile Test (Methylscape) in Body Fluids for Multi-Cancer Detection and Monitoring in Colombia","Evaluation of a Rapid Test for the Detection of Methylation Profiles (Methylscape) in Various Body Fluids as a Universal Biomarker for Cancer Detection and Monitoring","METHYLSCAPE-CO","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Willing and able to participate and to provide the required samples (blood, urine, saliva) and demographic information (age, sex, race\u002Fethnicity, BMI).\n* Able to provide written informed consent for participation and for use of biological samples. For CTIC Biobank samples, prior research-use consent is verified.\n* Demographic\u002Fanthropometric comparability (race, ethnicity, BMI) with other participants; race\u002Fethnicity by self-identification (WHO and national census categories); BMI per WHO categories.\n\nInclusion - Cancer cohort:\n\n* Cancer diagnosis confirmed within 90 days prior to sample collection.\n* Biopsy-proven malignancy with radiological staging.\n* No anticancer treatment at the time of collection or within the previous 3 years.\n* Inclusion - Cancer-free (healthy) cohort:\n* No cancer diagnosis or treatment in the previous 3 years (ICD-O-3 behavior code 2 or 3).\n* Not under evaluation for suspected cancer (verified by medical record review or additional medical evaluation).\n* Subjects with benign tumors (code 0) or tumors of uncertain behavior (code 1) may be included if there is no clinical evidence of progression or malignancy.\n\nAdditional criteria - tumor-burden monitoring (Sub-study 2b):\n\n* Biopsy-confirmed cancer.\n* ECOG performance status ≤ 2.\n\nExclusion Criteria (both cohorts):\n\n* Failure to meet the general or cohort-specific inclusion criteria.\n* Pregnancy.\n* Organ transplant recipients.\n* Use of demethylating agents (azacitidine, decitabine) or cytotoxic agents (including for autoimmune\u002Finflammatory conditions).\n* Prior or ongoing anticancer therapy: cancer surgery beyond that needed for diagnosis; local, regional, or systemic chemotherapy (including chemoembolization); targeted therapy; immunotherapy (including cancer vaccines); hormonal therapy; or radiotherapy.",{"count":658,"type":22},3250,"DNA methylation changes occur early and broadly during carcinogenesis. Methylscape is a rapid assay that detects global DNA methylation patterns in body fluids (blood, urine, and saliva) and may detect a cancer signal and predict the cancer signal origin (CSO) from a single fluid sample, using the differential interaction between methylated and unmethylated DNA and gold nanoparticles.\n\nThis prospective observational study evaluates the diagnostic performance (sensitivity and specificity) of the Methylscape test in Colombian patients with various biopsy-confirmed solid tumors compared with age- and sex-matched cancer-free (healthy) volunteers. The study is conducted in three parts: Phase 1 validates the assay in 250 patients with cancer; Sub-study 2a compares 1,500 patients with cancer against 1,500 matched cancer-free volunteers; and Sub-study 2b uses serial blood and urine sampling in 300 patients with early-stage disease to assess detection of disease relapse during follow-up, in parallel with standard imaging.\n\nThe study also estimates positive and negative predictive values (PPV\u002FNPV) and projects the budget impact and cost-effectiveness of Methylscape as a multi-cancer early detection (MCED) tool in an upper-middle-income Latin American setting.",[29,661,261,126,123,662,28,663,664,665,666],"Solid Tumor","Uterine Cervical Neoplasms","Urologic Neoplasms","Head and Neck Neoplasms","Early Detection of Cancer","Neoplasm Recurrence, Local",[668,669,670,671,672,673,674,675,676,677],"DNA methylation","Liquid biopsy","Cell-free DNA (cfDNA)","Multi-cancer early detection (MCED)","Methylscape","Cancer signal origin","Minimal residual disease","Methylation biomarker","Cancer screening","Colombia","2026-07-28",{"date":615,"type":44},{"date":681,"type":44},"2025-06-05",{"date":683,"type":22},"2028-01-15",{"name":685,"class":274},"Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo",{"id":687,"slug":688,"hasResults":12,"nctId":689,"briefTitle":690,"officialTitle":691,"acronym":4,"eligibilityCriteria":692,"healthyVolunteers":12,"sex":17,"minAge":693,"maxAge":593,"enrollmentInfo":694,"targetDuration":4,"studyType":23,"phases":696,"briefSummary":697,"conditions":698,"keywords":726,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":751,"startDateStruct":752,"completionDateStruct":754,"leadSponsor":756,"locationsCount":757},"100355699","phase-1-hsv-g207-in-children-with-recurrent-or-refractory-cerebellar-brain-tumors-100355699","NCT03911388","HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors","Phase 1 Trial of Engineered HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors","Inclusion Criteria:\n\n* Age ≥ 36 months and \\\u003C 22 years\n* Pathologically proven malignant cerebellar brain tumor (including medulloblastoma, glioblastoma multiforme, giant cell glioblastoma, anaplastic astrocytoma, primitive neuroectodermal tumor, ependymoma, atypical teratoid\u002Frhabdoid tumor, germ cell tumor, or other high-grade malignant tumor) which is progressive or recurrent despite standard care including surgery, radiotherapy, and\u002For chemotherapy. A pathologically proven secondary malignant cerebellar tumor without curative treatment options is eligible.\n* A review of the MRI scan will be necessary to determine if the tumor location and size are such that the patient may be included in the study. The MRI scan must be reviewed and approved by the site neurosurgeon and\u002For study radiologist for enrollment. The following guidelines must be met: Lesion must be ≤ 3.0 cm in diameter and surgically accessible as determined by MRI. Larger tumors may be surgically debulked and treated if ≤ 3.0 cm after debulking. Tumor measurements should be confirmed on the Immunotherapy Response Assessment in Neuro-Oncology (iRANO) form or the institutional MRI report\n* Patients must have fully recovered from acute treatment-related toxicities of all prior chemotherapy, immunotherapy or radiotherapy prior to the date of G207 administration. All washout intervals below are measured relative to the date of G207 administration.\n* Myelosuppressive chemotherapy: patients must have received their last dose at least 3 weeks prior (or at least 6 weeks if nitrosurea) to G207 administration.\n* Monoclonal antibodies: patient must have received the last dose ≥ 21 days prior to G207 administration\n* Investigational\u002FBiologic agents: patients must have recovered from any acute toxicities potentially related to the agent and received last dose ≥ 7 days prior to G207 administration (this period must be extended beyond the time during which adverse events are known to occur for agents with known adverse events ≥\\>= 7 days).\n* Viral therapy: Patients must have received viral therapy ≥ 3 months prior to G207 administration and must have recovered from all acute toxicities potentially related to the agent\n* Radiation: Patients must have received their last fraction of craniospinal radiation (\\>24 Gy) or total body irradiation ≥ 3 months prior to G207 administration. Patients must have received focal radiation to symptomatic metastatic sites or local palliative radiation ≥ 28 days prior to G207 administration.\n* Autologous bone marrow transplant: Patients must be ≥ 3 months since transplant prior to G207 administration.\n* Absolute neutrophil count \\> 1000\u002Fmm3\n* Platelets ≥ 100,000\u002Fmm\\^3\n* Prothrombin time (PT) or partial thromboplastin time (PTT) ≤ 1.3 x control\n* Creatinine within normal institutional limits OR creatinine clearance \\>60 mL\u002Fmin\u002F1.73 m\\^2 for patients with creatinine levels above institutional normal\n* Total bilirubin ≤ 1.5 mg\u002Fdl\n* Transaminases ≤ 3 times above the upper limits of the institutional norm\n* Patients \\\u003C 16 years, Modified Lansky performance score ≥ 60; patients ≥ 16 years, Karnofsky performance score ≥ 60\n* Written informed consent in accordance with institutional and Food and Drug Administration (FDA) guidelines must be obtained from patient or legal guardian\n\nExclusion Criteria:\n\n* Acute infection, granulocytopenia or medical condition precluding surgery\n* Pregnant or lactating females\n* Diagnosis of encephalitis or central nervous system (CNS) infection ≤ 3 months prior\n* Receiving ongoing treatment for encephalitis, CNS infection or multiple sclerosis\n* Tumor involvement which would require ventricular or brainstem inoculation or would require access through a ventricle in order to deliver treatment\n* Patient requires an escalation in ongoing systemic corticosteroid therapy within 7 days prior to G207 inoculation or requires ongoing systemic corticosteroid therapy at a dose \\> 2 mg\u002Fday of dexamethasone (or equivalent) at the time of inoculation. For this study, 'systemic corticosteroids' include oral, intravenous, or intramuscular formulations. A single, non-consecutive dose does not constitute exclusion. Physiologic corticosteroid replacement therapy (e.g., hydrocortisone for adrenal insufficiency) is not considered immunosuppressive and does not constitute exclusion\n* Known human immunodeficiency virus (HIV) seropositivity\n* Concurrent therapy with any drug active against herpes simplex virus (HSV) (acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir) or any immunosuppressive drug therapy (except dexamethasone or prednisone)\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen for this trial\n* Concurrent anticancer or investigational drug","36 Months",{"count":695,"type":22},24,[25],"This study is a clinical trial to determine the safety of inoculating G207 (an experimental virus therapy) into a recurrent or refractory cerebellar brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication, tumor cell killing, and an anti-tumor immune response, will also be tested.\n\nFunding Source- FDA OOPD",[699,700,701,29,702,703,704,705,706,707,708,709,710,711,712,713,714,71,70,715,716,717,718,451,529,530,719,720,721,722,723,724,725],"Neoplasms, Brain","Glioblastoma Multiforme","Glioblastoma of Cerebellum","Astrocytoma","Astrocytoma, Cerebellar","Neuroectodermal Tumors","Neuroectodermal Tumors, Primitive","Cerebellar PNET, Childhood","Cerebellar Neoplasms","Cerebellar Neoplasms, Primary","Cerebellar Neoplasm, Malignant","Cerebellar Neoplasm Malignant Primary","Neoplasm Metastases","Neoplasm Malignant","Neoplasms, Neuroepithelial","Neoplasms, Germ Cell and Embryonal","Neoplasms, Nerve Tissue","Central Nervous System Neoplasms, Primary","Central Nervous System Neoplasms, Malignant","Nervous System Neoplasms","Nervous System Diseases","Medulloblastoma Recurrent","HSV","Virus","Pediatric Brain Tumor","Nervous System Cancer","Primitive Neuroectodermal Tumor (PNET) of Cerebellum",[727,728,700,729,730,731,732,733,734,735,736,737,738,739,740,741,29,742,743,469,744,461,745,746,747,722,721,748,749,750],"Brain Tumor, Recurrent","Glioma","Gliosarcoma","Medulloblastoma","Anaplastic Astrocytoma","Oligodendroglioma","Rhabdoid Tumor","Ependymoma","Germ Cell Tumor","Choroid Plexus Carcinoma","Cerebral Primitive Neuroectodermal Tumor","Giant Cell Glioblastoma","Atypical teratoid\u002Frhabdoid tumor","Secondary Malignant Cerebellar Tumor","Embryonal Tumor","Oncolytic Virus Therapy","Virotherapy, Oncolytic","Central Nervous System Agents","Pediatric","Pediatrics","Oncolytic","Herpes Virus","G207","Oncolytic Herpes Virus",{"date":640,"type":44},{"date":753,"type":44},"2019-09-12",{"date":755,"type":22},"2027-09-01",{"name":379,"class":274},3,{"id":759,"slug":760,"hasResults":12,"nctId":761,"briefTitle":762,"officialTitle":763,"acronym":764,"eligibilityCriteria":765,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":766,"targetDuration":4,"studyType":23,"phases":768,"briefSummary":769,"conditions":770,"keywords":773,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":789,"lastUpdatePostDateStruct":790,"startDateStruct":792,"completionDateStruct":794,"leadSponsor":796,"locationsCount":171},"100648963","ready-for-safe-cancer-treatment-reset-a-comprehensive-perioperative-program-for-surgical-oncology-100648963","NCT07727876","Ready for Safe Cancer Treatment (RESET): A Comprehensive Perioperative Program for Surgical Oncology","Comprehensive Tool to Improve the Quality and Optimize Hospitalization of Oncological Surgery Patients Implemented for Timely, Safe Discharge From Hospital - Ready for Safe Cancer Treatment RESET, Consisting of a Standardized Sequence of Processes -From Prehabilitation, Therapeutic Team\u002FPatient\u002FFamily Advanced Communication, Early Rehabilitation Protocol, Followed by Individual Transitional Care Program, Dedicated to Oncology Network Hospitals","RESET","ONCOLOGY GROUP\n\nInclusion Criteria:\n\n* Age ≥ 18 years\n* Qualification for admission to surgical departments with an ICD10 diagnosis for radical cancer surgery\n* Preliminary qualification for one of the procedures listed in Section II.B.23\n* Informed consent to participate in the study\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Qualification for admission to surgical departments with an ICD10 diagnosis for diagnostic procedures to identify cancer\n* Pregnancy or breastfeeding\n\nNON-ONCOLOGY GROUP\n\nInclusion Criteria:\n\n* Informed consent to participate in the study\n* Age ≥ 70 years\n* All consecutive patients referred for planned non-oncological surgical procedures, not solely diagnostic, performed under general anesthesia\n\nExclusion Criteria:\n\n\\- Diagnosis of cancer",{"count":767,"type":22},12800,[257],"The goal of this randomized controlled clinical trial is to evaluate whether the Ready for Safe Cancer Treatment (RESET) program improves perioperative care and supports safe hospital discharge in two surgical populations: adult patients undergoing planned oncological surgery and patients aged 70 years or older undergoing planned non-oncological surgery under general anesthesia.\n\nRESET is a comprehensive, multidisciplinary care pathway that combines prehabilitation, standardized perioperative care, enhanced recovery, and individualized transitional care after discharge.\n\nThe main questions it aims to answer are:\n\nDoes the RESET program reduce postoperative complications, prolonged hospitalizations, and unplanned rehospitalizations after oncological and non-oncological surgery?\n\nDoes the RESET program improve patients' overall health status, physical function, quality of life, perioperative safety, and recovery?\n\nDoes implementation of RESET improve the organization and efficiency of hospital care while reducing healthcare resource utilization and costs?\n\nResearchers will compare patients receiving the RESET program with patients receiving standard perioperative care to determine whether the comprehensive intervention leads to improved clinical, organizational, and patient-reported outcomes.\n\nParticipants assigned to the RESET intervention will:\n\nundergo a comprehensive multidisciplinary prehabilitation assessment performed by a physician, physiotherapist, dietitian, psychologist, clinical pharmacist, nurse, and study coordinator;\n\nreceive an individualized prehabilitation program that may include physical exercise, nutritional support, psychological support, medication optimization, and patient education before surgery;\n\nuse a dedicated RESET mobile application to communicate with the multidisciplinary prehabilitation team, ask questions, receive individualized recommendations and information, follow the schedule of visits and planned activities, and support adherence to the intervention;\n\nundergo reassessment of their health status, needs, and implementation of recommendations on the day of hospital admission, allowing barriers to be identified and the perioperative care plan to be optimized;\n\nreceive standardized in-hospital perioperative care incorporating Enhanced Recovery After Surgery principles, the SAFER Patient Flow Bundle, the Red2Green methodology, medication review by a clinical pharmacist, and coordinated multidisciplinary care;\n\nreceive an individualized transitional care plan after discharge, including follow-up support and monitoring for complications and rehospitalization.\n\nParticipants in the control group will receive standard perioperative care according to routine clinical practice at the participating hospitals.\n\nThe study will evaluate clinical outcomes, including postoperative complications, prolonged hospitalization, rehospitalization, recovery, overall health status, physical function, and quality of life. It will also evaluate patient satisfaction, adherence to the RESET pathway, organizational effectiveness, and costs associated with implementation of RESET.\n\nThe results are expected to support the development of an evidence-based and scalable perioperative care model that can be used in oncological surgery and in older patients undergoing major non-oncological surgery.",[29,771,772],"Frailty","Surgical Procedures, Operative",[774,775,776,777,778,779,780,781,782,783,784,785,786,787,788],"prehabilitation","perioperative care","surgical oncology","enhanced recovery after surgery","transitional care","hospital discharge","multidisciplinary care","postoperative complications","rehospitalization","prolonged hospitalization","patient flow","frailty","geriatric surgery","cancer surgery","supportive care","2026-07-24",{"date":791,"type":44},"2026-07-27",{"date":793,"type":44},"2026-02-16",{"date":795,"type":22},"2031-07-31",{"name":797,"class":274},"Regional Specialist Hospital in Wroclaw"]