[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Memorial Sloan Kettering Cancer Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":648},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,325,0,25,[9,46,73,98,123,151,177,200,225,249,267,305,331,355,377,401,432,457,479,499,523,547,576,599,626],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":45},"100054248",false,"NCT05607095","A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, Dedifferentiated Liposarcoma, or Angiosarcoma","A Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) for Patients With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, Dedifferentiated Liposarcoma, or Angiosarcoma","Inclusion Criteria:\n\n* Cohort 1: Must have a confirmed diagnosis of metastatic Uveal Melanoma.\n\n  o Patients will be eligible regardless of the number of prior systemic therapies received.\n* Cohort 2: Must have a confirmed diagnosis of unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) that is refractory to at least 1 prior line of systemic therapy\n\n  * Unresectable disease will be defined by an expert sarcoma surgical oncologist as either (a) low likelihood of obtaining an R0 resection or (b) unacceptable morbidity from a surgical procedure\n  * Prior systemic therapy in the neoadjuvant or adjuvant setting will count has prior systemic therapy\n  * Patients who refuse standard of care chemotherapy will be eligible\n* Cohort 3: Must have a confirmed diagnosis of unresectable or metastatic angiosarcoma that is refractory to at least 1 prior line of systemic therapy\n\n  * Unresectable disease will be defined by an expert sarcoma surgical oncologist as either (a) low likelihood of obtaining an R0 resection or (b) unacceptable morbidity from a surgical procedure\n  * Prior systemic therapy in the neoadjuvant or adjuvant setting will count has prior systemic therapy\n  * Patients who refuse standard of care chemotherapy will be eligible\n* One (1) lesion at least 1.5cm in size (solitary or aggregate) available for TIL harvesting that has not undergone prior embolization or RT in prior 3 months unless subsequent growth is demonstrated (at least 0.5cm).\n* Patients must be ≥ 18 years of age at the time of consent.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Patients must have an estimated life expectancy of ≥ 6 months in the opinion of the Investigator.\n* Patients must have the following hematologic parameters:\n\n  * Absolute neutrophil count (ANC) ≥ 1000\u002Fmm3\n  * Hemoglobin (Hb) ≥ 9.0 g\u002FdL\n  * Platelet ≥ 100,000\u002Fmm\\^3 Note: Transfusions or growth factors are not allowed 28 days prior to signing the ICF and continuing through the Screening Period\n* Patients must have adequate organ function:\n\n  * Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (≤ 3 × ULN); patients with liver metastasis ≤ 5 × ULN\n  * Estimated creatinine clearance (eCrCl) ≥ 40 mL\u002Fmin using the Cockcroft-Gault formula at Screening\n  * Total bilirubin ≤ 2 mg\u002FdL\n  * Patients with Gilbert's syndrome must have a total bilirubin ≤ 3 mg\u002FdL\n* Patients must be seronegative for the following:\n\n  * Human immunodeficiency virus (HIV)-1 or HIV-2 antibodies\n  * Hepatitis B antigen (HBsAg), hepatitis B core antibody (anti- HBc), or hepatitis C antibody (HCV Ab). Patients with acute or chronic hepatitis infections may be enrolled if the viral load by polymerase chain reaction (PCR) is undetectable with\u002Fwithout active treatment.\n  * Syphilis (Rapid Plasma Reagin \\[RPR\\] test or venereal disease research laboratory \\[VDRL\\] test)\n  * Cytomegalovirus (CMV) IgM antibody titer or PCR assay; and Epstein-Barr virus (EBV) IgM or PCR assay indicating active infection\n  * Herpes simplex virus (HSV)-1 and HSV-2 IgM serology or PCR assay\n* Patients who are HSV immunoglobulin M (IgM) or PCR assay positive will need to receive appropriate treatment and become IgM or PCR assay negative prior to starting the NMA-LD pre-conditioning regimen\n* Anyone with prior COVID-19 infection must be asymptomatic for \\>30 days prior to NMA-LD.\n* Patients must have a washout period from prior anticancer therapy(ies) of a minimum duration, as detailed below prior to the first study treatment (ie, start of NMA-LD):\n\n  * Targeted therapy: prior targeted therapy with an EGFR, MEK, BRAF, ALK, ROS1, or other-targeted agents (eg, erlotinib, afatinib, dacomitinib, osimertinib, crizotinib, ceritinib, lorlatinib) is allowed provided the washout is a minimum of 14 days or 5 half-lives (whichever is longer) prior to the start of treatment\n  * Chemotherapy: minimum of 21 days prior to the start of treatment\n  * Immunotherapy: checkpoint-targeted therapy with an anti PD-1\u002Fanti PD-L1, other monoclonal antibodies, or vaccines are allowed, provided the washout is a minimum of 21 days prior to the start of study treatment\n* Palliative radiation therapy is permitted so long as it does not involve lesions being selected for TIL, or as target or non-target lesions. Washout is not required if all related toxicities have resolved to ≤ Grade 1 as per CTCAE v 5.0.\n* Patients must have recovered from all prior anti-cancer therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\] v 5.0), except for alopecia or vitiligo, prior to enrollment.\n\n  * Patients with documented ≥ Grade 2 diarrhea or colitis as a result of previous treatment with immune checkpoint inhibitor(s) must have been asymptomatic for at least 6 months and\u002For had a normal colonoscopy post-immune checkpoint inhibitortreatment, by visual assessment, prior to tumor resection.\n  * Patients with immunotherapy-related endocrinopathies (e.g. hypothyroidism) stable for at least 6 weeks and controlled with hormonal replacement are allowed.\n* Previous surgical procedure(s) is\u002Fare permitted provided that wound healing has occurred, all complications have resolved, and at least 14 days have elapsed (for major operative procedures) prior to the tumor resection.\n* Patients of childbearing potential (or female partners of male participants) must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after their last dose of IL-2. Approved methods of birth control are as follows:\n\n  * Combined (estrogen and progesterone containing) hormonal birth control associated with inhibition of ovulation: oral, intravaginal, transdermal\n  * Progesterone-only hormonal birth control associated with inhibition of ovulation: oral, injectable, implantable\n  * Intrauterine device (IUD)\n  * Intrauterine hormone-releasing system (IUS)\n  * Bilateral tubal occlusion\n  * Vasectomized partner\n  * True sexual abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar ovulation, symptothermal, post-ovulation methods) is not acceptable\n* Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an ICF approved by an Institutional Review Board\u002FIndependent Ethics Committee (IRB\u002FIEC), and agree to abide by the study restrictions and return to the site for the required assessments, including the OS Follow-up Period.\n\nExclusion Criteria:\n\n* Patients who have received an organ allograft or prior cell transfer therapy that included a non-myeloablative or myeloablative chemotherapy regimen.\n* Patients who have a history of hypersensitivity to any component or excipient of LN-144\u002FLN-145 or other study drugs:\n\n  * NMA-LD preconditioning regimen (cyclophosphamide, mesna, and fludarabine)\n  * Proleukin®, aldesleukin, IL-2\n  * Antibiotics (ABX) of the aminoglycoside group (i.e., streptomycin, gentamicin); except those who are skin-test negative for gentamicin hypersensitivity\n  * Any component of the LN-144\u002FLN-145 infusion product formulation including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40.\n* Patients with symptomatic brain metastases (of any size and any number).\n\n  o Patients with definitively treated brain metastases may be considered for enrollment, if, prior to tumor resection for TIL, the patient is clinically stable for ≥ 14 days, there are no symptomatic brain lesions, and that the patient does not require ongoing corticosteroid treatment.\n* Patients who are on chronic systemic immunosuppressive therapy except for those requiring steroid therapy for management of adrenal insufficiency; these patients may receive no more than 10 mg of prednisone or its equivalent daily. Transient use of steroids, e.g. in the perioperative period, is not an exclusion.\n* Patients who are pregnant or breastfeeding.\n* Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.\n* Patients who have received a live or attenuated vaccination within 28 days prior to the start of NMA-LD pre-conditioning regimen.\n* Patients who have any form of primary immunodeficiency (such as severe combined immunodeficiency disease \\[SCID\\] and acquired immunodeficiency syndrome \\[AIDS\\]).\n* Patients who have a left ventricular ejection fraction (LVEF) \\\u003C45% or New York Heart Association (NYHA) functional classification \\> Class 1.\n\n  * Patients ≥ 60 years of age and who have a history of ischemic heart disease, chest pain, or clinically significant atrial and\u002For ventricular arrhythmias must have a cardiac stress test.\n  * Patients with any irreversible wall movement abnormalities are excluded.\n* Patients who have a smoking history or signs or symptoms of obstructive or restrictive pulmonary disease and have a documented forced expiratory volume in 1 second (FEV1) of ≤ 60% of predicted normal:\n\n  * If a patient is not able to perform reliable spirometry due to abnormal upper airway anatomy (i.e., tracheostomy), a 6-minute walk test may be used to assess pulmonary function.\n  * Patients who are unable to walk a distance of at least 80% predicted for age and sex or demonstrates evidence of hypoxia at any point during the test (SpO2 \\\u003C 90%) are excluded.\n* Active, uncontrolled systemic infections, including COVID-19, within 30 days of surgery or NMA-LD. An uncomplicated bacterial UTI treated successfully with symptom resolution is not an exclusion.\n* Participation in another clinical study with an investigational product within 21 days of the initiation of NMA-LD.\n* No other active, concurrent malignancy that requires ongoing systemic treatment (e.g. indolent prostate) or interferes with radiographic assessment of response as determined by the investigator. Exceptions may allow for adjuvant NED cancers undergoing hormone-based therapy assuming the other eligibility criteria are met and the PI affirms the hormonal agent would not change the response.\n\nEligibility Designation for Lymphodepletion\n\nPatients meeting eligibility criteria above between Day -21 and Day -8 prior to the planned initiation of lifileucel will be enrolled to the therapeutic portion of the protocol.\n\nAll patients' eligibility criteria, including repeating cardiopulmonary function tests as necessary, will be reassessed within several days prior to the scheduled lymphodepletion in all cases.\n\nPrior to beginning the NMA-LD preparative regimen the following requirements must be met:\n\n* Patients must meet all eligibility criteria at the time of NMA-LD.\n* Full resolution of any active infection should be documented\n* Critical evaluation of changes in cardiovascular, respiratory, renal, coagulopathy, or immune problems and other major illnesses that may have developed or worsened must be documented\n* Patients with symptomatic, recurrent, pleural effusions that require drainage should not proceed to lymphodepletion without prior placement of a temporary in-dwelling pleural drain\n* All active medical issues must be addressed by Investigator or designee. Re-evaluation with additional imaging or testing may be required\n\nBenefit over risk should be assessed and reassessed throughout the treatment course. Successive lifileucel components (preparative lymphodepleting chemotherapy, LN-144\u002FLN-145 and IL-2 ) should be withheld or discontinued if at any time during the treatment course, at the discretion of the treating physician, benefit may not be justified by risks to the patient\n\nSubsequent delays of lymphodepletion up to 14 days due to logistical issues such as production of lifileucel and\u002For major weather events will not constitute protocol violations and out of window assessments will not need to be repeated unless there is a change in clinical status.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma.",[26,27,28,29],"Uveal Melanoma","Melanoma","Metastatic Uveal Melanoma","Metastatic Melanoma",[26,27,28,29,31,32,33],"LN-144","22-109","Memorial Sloan Kettering Cancer Center","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2022-11-01",{"date":42,"type":20},"2027-05-01",{"name":33,"class":44},"OTHER",2,{"id":47,"slug":4,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100054312","NCT07270666","ctDNA Testing to Inform Standard-of-Care Treatment Decisions in People With Endometrial Cancer","Pragmatic Pilot Study of ctDNA Informed Immune Checkpoint Inhibitor De-escalation in Advanced\u002FRecurrent Mismatch Repair Deficient (MMR-D)\u002FMicrosatellite Instability High (MSI-H) Endometrial Cancer Using Standard of Care Treatments","Inclusion Criteria:\n\n* Patients must have pathologically confirmed endometrial cancer\n* Patients with advanced endometrial cancer\n* Stage III with residual disease\n\n  °Select patients with Stage III disease and no residual disease can be enrolled after discussion with PI\n* Stage IV\n* Recurrent endometrial cancer after adjuvant therapy only\n* Patients can have primary or planned interval surgery\n* MMR-D on immunohistochemistry OR MSI-H using any commercially available test\n* Patients with treated brain metastases are eligible if follow up brain imaging after CNS directed therapy shows no evidence of progression.\n* Eligible for standard of care chemotherapy with immune checkpoint inhibitor per treating investigator with no clinical contraindications\n* For the up to 10 patients who are allowed to enroll after C1D1 of standard of care treatments, they need to be on treatment with no clinical evidence of disease progression.\n\n  * Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic\u002Fpara aortic radiation therapy, intravaginal brachytherapy, and\u002For palliative radiation therapy.\n  * Patients may have received prior hormonal therapy for treatment of endometrial cancer.\n  * Patients may not have received prior therapy with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapeutic antibody or other similar agents.\n\n    * Except for the up to 10 patients who are allowed to enroll after C1D1 of standard of care treatments (chemotherapy and\u002For immune checkpoint inhibitors) per protocol.\n* Age ≥ 18\n* Not Pregnant and Not Nursing","FEMALE",{"count":54,"type":20},30,[56],"NA","The researchers are doing this study to evaluate the use of circulating tumor DNA (ctDNA) testing in making treatment decisions for advanced\u002Frecurrent endometrial cancer that has a change (mutation) in the mismatch repair deficient (MMR-D) gene or microsatellite instability high (MSI-H) gene. The researchers will see how doctors and their patients use the results of ctDNA testing after 1 year of standard chemotherapy and immune checkpoint inhibitor (ICI) treatment to decide whether to continue maintenance ICI treatment past 1 year. The researchers will also look at the health outcomes of people in this study (for example, whether they are cancer free at the end of their participation in the study).",[59],"Endometrial Cancer",[61,62,63,64,65],"Stage III with residual disease","Stage IV","Recurrent endometrial cancer after adjuvant therapy only","ctDNA Testing","25-337",{"date":37,"type":38},{"date":68,"type":38},"2025-11-25",{"date":70,"type":20},"2027-11",{"name":33,"class":44},7,{"id":74,"slug":4,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":72},"100054039","NCT06703476","A Study of Surgical Techniques During Cystectomy","A Clinically Integrated Randomized Clinical Trial (RCT) of Modifications to Radical Cystectomy and Postoperative Care","Inclusion Criteria:\n\nStent vs. no stent\n\n* Patients aged ≥21 years who are scheduled to undergo radical cystectomy for treatment of bladder cancer with one of the consenting surgeons Alvimopan vs. no alvimopan\n* Patients aged ≥21 years who are scheduled to undergo radical cystectomy for treatment of bladder cancer with one of the consenting surgeons\n\nExclusion Criteria:\n\nStent vs. no stent\n\n* No exclusion criteria\n\nAlvimopan vs. no alvimopan\n\n* Patients on chronic opioid therapy are ineligible to receive alvimopan and will be excluded from this cohort of the trial","21 Years",{"count":81,"type":20},530,[83],"PHASE3","The purpose of this study is to look at two standard surgical techniques used during a radical cystectomy and see whether they influence outcomes such as length of stay in the hospital and infections after surgery. This trial will evaluate whether the following surgical methods influence outcomes:\n\nA ureteral stent is a thin tube that is placed in the ureter to drain urine from the kidney. Ureteral stents are often used to promote urine drainage after radical cystectomy, but may come at risk of urinary tract infection.\n\nAlvimopan is a standard drug used to promote return of bowel function following surgery. Doctors do not know whether alvimopan is beneficial in current clinical practice.\n\nThe surgeon will decide whether participants will receive a stent and\u002For alvimopan, but if they are unsure what the best approach is, a surgical technique has been assigned by chance to them.",[86],"Bladder Cancer",[88,89,90,91],"Cystectomy","Ureteral stents","Alvimopan","24-361",{"date":37,"type":38},{"date":94,"type":38},"2024-11-21",{"date":96,"type":20},"2028-11",{"name":33,"class":44},{"id":99,"slug":4,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":72},"100053718","NCT07535437","A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer","A Phase 1\u002F2 Trial of Ivonescimab With Dato-DXd or Osimertinib in Patients With Metastatic EGFR-mutant Non-small Cell Lung Cancer That Progressed on EGFR TKI Therapy","Inclusion Criteria:\n\n* Written informed consent by participant\n* Biopsy-proven metastatic non-small cell lung cancer\n* Somatic activating mutation in EGFR in pre-treatment tumor biopsy or cfDNA (including all mutations with sensitivity to osimertinib) by any CLIA certified assay.\n* Prior treatment with 3rd-generation EGFR TKI therapy and platinum-based chemotherapy (or ineligible for platinum-based chemotherapy)\n* At least one measurable (RECIST 1.1) indicator lesion not previously irradiated\n* ECOG PS 0-1\n* Age ≥18 years old\n* Ability to swallow oral medications (Study Cohort B only)\n* Adequate organ function\n\n  * AST, ALT ≤ 2.5 x ULN; For patients with liver metastases, AST and ALT ≤ 5 × ULN\n  * Total bilirubin ≤ 1.5x ULN; For patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤3 × ULN Creatinine clearance (CrCl) ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥50 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n  * Urine protein \\\u003C 2+ or 24 hour urine protein quantification \\\u003C 1.0 g\n  * Absolute neutrophil count (ANC) ≥ 1500 cells\u002Fmm\\^3\n  * Hemoglobin ≥ 9.0 g\u002FdL (red blood cell\u002Fplasma transfusion is not allowed within 2 weeks prior to screening assessment)\n  * Platelets ≥100,000\u002Fmm3 (platelet transfusion is not allowed within 10 days prior to screening assessment)\n  * Coagulation: prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 × ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy). This applies only to patients who are not on therapeutic anti-coagulation. Patients receiving therapeutic anti-coagulation should be on a stable dose.\n* Female patients of childbearing age must have negative serum pregnancy test and a negative urine pregnancy test on the day of first dose prior to dosing.\n* Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the ivonescimab and\u002For 3 months after last dose of Dato-DXd or 6 weeks after last dose of osimertinib\n* Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom plus spermicide) for the duration of the treatment period until 90 days after the last dose of ivonescimab and\u002For 6 months after the last dose of Dato-DXd or 6 weeks after last dose osimertinib. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of ivonescimab and\u002For 3 months after the last dose of Dato-DXd or 6 weeks after last does of osimertinib.\n\nExclusion Criteria:\n\n* EGFR exon 20 insertion positive lung cancer with expected lack of sensitivity to osimertinib (Study Cohort B only).\n* Pregnant or lactating women\n* Participation in another clinical study and receiving treatment with an investigation product during the last 4 weeks before enrollment\n* Prior exposure to anti-PD-1 inhibitor therapy\n* Prior exposure to antibody drug conjugate (ADC) containing chemotherapeutic agent targeting topoisomerase I, TROP2 antibody (Study Cohort A only).\n* History of clinically significant corneal disease (Study Cohort A only)\n* Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n* Major surgical procedures or serious trauma within 4 weeks of study enrollment, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior study enrollment.\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks of study enrollment, including but not limited to:\n\n  * Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots). Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n  * Significant nasal bleeding \u002Fepistaxis (bloody nasal discharge is allowed)\n  * Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to first study drug treatment is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.\n* Active (eg, with disease modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy) or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\n  * Short course of steroids if given for infection\n  * Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n  * Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted\n  * Patients with vitiligo or alopecia\n  * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Patients without active disease in the last 5 years may be included but only after consultation with the study physician\n  * Patients with celiac disease controlled by diet alone\n* History of major diseases before first study drug treatment, specifically:\n\n  * Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to first study drug treatment, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n  * History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months of study enrollment\n  * History of any grade arterial thromboembolic event as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months before first ivonescimab infusion\n  * Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before first ivonescimab infusion\n  * History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months before first ivonescimab infusion\n* Imaging during the screening period shows that the patient has:\n\n  * Radiologically documented evidence of major blood vessel invasion (central pulmonary artery, central pulmonary veins, aorta, brachiocephalic artery, common carotid artery, subclavian artery, superior vena cava) or tumor invading organs (heart, trachea, esophagus, central bronchi \\[not including segmental bronchi\\]) or if there is a risk of esophagotracheal or esophagopleural fistula in the opinion of the investigator.\n  * Radiographic evidence of major blood vessel encasement with narrowing of the vessel or intratumor lung cavitation or necrosis that the investigator determines will pose a significantly increased risk of bleeding.\n* History of another primary malignancy except for:\n\n  * Malignancy treated with curative intent and with no known active disease ≥ 2 years before the first dose of study drugs and of low potential risk for recurrence\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without- evidence of disease\n  * Adequately treated carcinoma in situ without evidence of disease\n* Symptomatic CNS metastases, CNS metastases with hemorrhagic features, CNS radiation within 7 days prior to first study drug treatment, potential need for CNS radiation within the first cycle, or symptomatic leptomeningeal disease.\n\nNote: Patients must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).\n\n* Live vaccine or live attenuated vaccine within 4 weeks prior to first ivonescimab infusion, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted.\n* Severe infection within 4 weeks prior to first ivonescimab infusion, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to first study drug treatment (excluding antiviral therapy for hepatitis B or C)\n* Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5\n* Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic Note: Patients managed with indwelling catheters (eg, PleurX) are allowed.\n* History of interstitial lung disease (ILD) requiring steroids\n* Current use of systemic corticosteroids (\\>10 mg daily prednisone or equivalent)\n* Known history of human immunodeficiency virus (HIV) whose viral load is not controlled.\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n* Patients with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for one month prior to first study drug treatment. All patients with active hepatitis C (hepatitis C virus \\[HCV\\] antibody positive with HCV RNA levels above the lower limit of detection) are excluded.\n* Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies\n* History or current evidence of any condition (medical \\[including adverse events from prior anticancer therapy, disorders secondary to tumor\\], surgical or psychiatric \\[including substance abuse\\]), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, might lead to higher medical risk and\u002For is not in the best interest of the patient to participate, in the opinion of the treating investigator.",{"count":105,"type":20},66,[23,107],"PHASE2","The researchers are doing this study to find out whether ivonescimab in combination with datopotamab deruxtecan- (Dato-DXd) or osimertinib are safe and effective treatments in people with non-small cell lung cancer (NSCLC) that has an EGFR mutation. The researchers will test different doses of the Dato-DXd or osimertinib with an unchanging (fixed) dose of ivonescimab to find the best dose that causes few or mild side effects in participants. Once the dose is found the researchers will test ivonescimab with Dato-DXd or osimertinib in a new group of participants to see if it is effective in treating their NSCLC with an EGFR mutation.",[110],"Non-Small Cell Lung Cancer",[112,113,114,115,116],"Ivonescimab","Dato-DXd","Osimertinib","Metastatic EGFR-Mutant","25-366",{"date":37,"type":38},{"date":119,"type":38},"2026-04-09",{"date":121,"type":20},"2028-04",{"name":33,"class":44},{"id":124,"slug":4,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":129,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":139,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},"100053279","NCT06037954","A Study of Mental Health Care in People With Cancer","Mental Health Care Initiation Intervention for Older Adults With Cancer","Inclusion Criteria:\n\nPatients\n\n* Per medical record and\u002For self-report, diagnosed with breast, colorectal, lung, or prostate cancer at age 65 years or older\n* Per medical record and\u002For self-report, undergoing active cancer treatment (e.g., radiation, chemotherapy, immunotherapy, surgery) or within six months of completing treatment\n* Score of ≥5 on the Patient Health Questionnaire-9 (PHQ-9)\n* Per self-report, fluent in English\\*\\* \\*\\* Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify English fluency necessary for participation in the study:\n\n  1. How well do you speak English? (must respond \"very well\" or \"well\" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)\n  2. What is your preferred language for healthcare? (must respond English)\n\nProviders\n\n* Per self-report, works in oncology, nursing, social work, psychology, or psychiatry\n* Per self-report, currently works in oncology at least 50% of the time\n* Per self-report, provided cancer care for at least three years at time of consent\n* Per self-report, fluent in English\n\nExclusion Criteria:\n\nPatients\n\n* Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration scores of ≥ 11\n* Per research staff judgment and\u002For self-report, too ill or weak to complete study procedures\n* Per medical record and\u002For self-report, receiving hospice care at the time of enrollment\n* Per medical record and\u002For self-report, currently enrolled in mental health treatment\n\nProviders\n\n* N\u002FA","65 Years",{"count":131,"type":20},130,[56],"The purpose of this study is to look at mental health services for adults with depressed mood who were diagnosed with cancer at the age of 65 or older. This study will compare the usual approach for connecting older adults with depressed mood to mental health services with the Open Door for Cancer (OD-C) approach. We will find out if the OD-C approach is practical and useful for cancer patients who participate in the intervention and for providers who see or treat cancer patients.",[135,136,137,138],"Breast Cancer","Colorectal Cancer","Lung Cancer","Prostate Cancer",[140,141,142],"65 years and older","Mental health care","23-218","2026-07-09",{"date":37,"type":38},{"date":146,"type":38},"2023-09-07",{"date":148,"type":20},"2026-09",{"name":33,"class":44},1,{"id":152,"slug":4,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":168,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":72},"100053855","NCT07698899","A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS)","A Phase I Dose Escalation Trial of Compartmental Radioimmunotherapy (cRIT) Using 177Lu-DTPA-omburtamab in Pediatric and Adolescent Patients With Recurrent or Refractory B7H3 Expressing Primary or Metastatic CNS Tumors","Inclusion Criteria:\n\n\\- Disease type:\n\n* Histologically confirmed diagnosis of a tumor that is known to express B7-H3 including but not limited to neuroblastoma, medulloblastoma, rhabdoid tumors, pineoblastoma, retinoblastoma, CNS embryonal tumor, rhabdomyosarcoma, Ewing's sarcoma and ependymoma.\n\n  * Disease status:\n* Patients must have recurrent or refractory disease with CNS parenchymal and\u002For leptomeningeal disease which has been treated with conventional therapies or for which no conventional therapy exists. Measurable or evaluable disease is not required at time of enrollment.\n\n  \\- Age: Patients must be ≥ 3 and \\\u003C 22 years of age at the time of enrollment.\n  * Prior Therapy: The participant must have recovered from acute toxic effects of prior anti-cancer therapies with the following minimum duration from prior therapy:\n* Chemotherapy: Patients must have received their last dose of known myelosuppressive anticancertherapy at least 21 days (3 weeks) prior to enrollment or at least 42 days (6 weeks) if prior nitrosourea.\n* Anti-GD2 monoclonal antibody (neuroblastoma patients): Patients must have received their last dose of anti-GD2 mAb at least 14 days (2 weeks) before enrollment.\n* Radiation: Patients must have had their last fraction of:\n\n  * Craniospinal irradiation, whole brain radiation, or total body irradiation at least 21 days (3 weeks) prior to study enrollment.\n  * Focal radiation to areas of symptomatic metastatic disease at least 14 days (2 weeks) prior to study enrollment.\n* Stem Cell Transplant (SCT): For autologous SCT, 60 days (≥ 2 months) must have elapsed before study enrollment. Patients who have received an autologous hematopoietic stem cell injection to support non- myeloablative therapy (such as 131 I-MIBG) are eligible at any time as long as they meet the other criteria for eligibility. 131\n* I-MIBG therapy or treatment with other radiopharmaceuticals (neuroblastoma 131 patients): A minimum of 42 days (6 weeks) must have elapsed after I-MIBG therapy before start of protocol therapy.\n* Investigational\u002FBiologic Agent (anti-neoplastic): Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent ≥ 7 days (1 week) prior to study enrollment.\n* Molecular targeted therapies: Patients must complete a washout period from last therapy that is either 7 days (1 week) or 3 half-lives, whichever is longer.\n\n  * Patients with neurological deficits should have deficits that are stable for a minimum of 7 days (1 week) prior to enrollment.\n  * Patients with seizure disorders may be enrolled if seizures are controlled.\n  * Karnofsky Performance Scale (KPS for \\> 16 years of age) or Lansky Performance Score (LPS for ≤ 16 years of age) assessed within 14 days (2 weeks) prior to study enrollment must be ≥ 50%.\n* Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n\n  * Peripheral absolute neutrophil count (ANC) ≥ 0.5x 109\u002F L (must not have received G-CSF within 7 days (1 week) prior to enrollment or pegfilgrastim within 14 days (2 weeks) prior to enrollment.\n  * Platelet count ≥ 75 x 109\u002F L. Growth factor support (romiplostim or biosimilar) is permitted both prior to and during therapy.\n* For patients with neuroblastoma (regardless of marrow disease status) and other solid tumors known bone marrow infiltration from disease: platelet count ≥ 50 x 109\u002F L (with no platelet transfusion within 7 days prior to study enrollment).\n\n  \\- Adequate Renal Function Defined as:\n\n  \\- A creatinine based on age\u002Fgender as follows: Age; Maximum Serum Creatinine (mg\u002FdL) Male and Female\n\n  1 month to \\\u003C 6 months; 0.4, 0.4 6 months to \\\u003C 1 year; 0.5, 0.5\n  1. to \\\u003C 2 years; 0.6, 0.6\n  2. to \\\u003C 6 years; 0.8, 0.8\n\n  6 to \\\u003C 10 years; 1, 1 10 to \\\u003C 13 years; 1.2. 1.2 13 to \\\u003C 16 years; 1.5, 1.4\n\n  ≥ 16 years; 1.7, 1.4\n  * The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the CDC.\n  * Adequate Liver Function Defined as: - Bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (or ≤ 3 x ULN if Gilbert's syndrome) - SGPT (ALT) \\\u003C 135 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL.\n  * Presence of an appropriate intraventricular access device (e.g., programmable ventriculoperitoneal \\[VP\\] shunt or Ommaya reservoir). Patients are not required to have an existing programmable VP shunt or Ommaya at the time of study enrollment but must be willing and able to undergo a surgical procedure to have one placed prior to cRIT.\n* Note: Patients with an existing intraventricular VP shunt without a programmable component must be willing and able to undergo modification of the shunt.\n\n  * Patients may have active malignancy outside the central nervous system but do not immediately require treatment for systemic disease. Neuroblastoma patients with CNS and systemic disease will only receive 1 dose of cRIT 177Lu- omburtamab while patients with CNS metastases in the absence of systemic disease can receive 2 doses of cRIT 177Lu-omburtamab.\n  * Patients may be on standing steroids, as long as the dosage is either stable or decreasing for at least 7 days (1 week) prior to enrollment.\n  * Human Anti-Mouse Antibody (HAMA) testing will be performed prior to 177Lu-DTPAomburtamab.\n\nExclusion Criteria:\n\n* Patients with obstructive or symptomatic communicating hydrocephalus.\n* Patients with an uncontrolled life-threatening infection.\n* Patients who are pregnant:\n\n  o A negative pregnancy test is required for all women of childbearing age, and appropriate contraception for 3 months after the last dose of 177Lu-DTPAomburtamab is required during the study period.\n* Severe major organ toxicity:\n\n  * Cardiac, pulmonary, and gastrointestinal system toxicity should all be \\\u003C grade 2\n  * Patients with grade 4 hearing loss are excluded","3 Years","22 Years",{"count":160,"type":20},18,[23],"The purpose of this study is to find out whether 177Lu-DPTA-omburtamab is a safe treatment for children and adolescents with recurrent\u002Frefractory medulloblastoma or another type of cancer with CNS metastases.",[164,165,166,167],"Recurrent Medulloblastoma","Refractory Medulloblastoma","CNS Metastases","Central Nervous System Metastasis",[164,165,166,167,33,169,170],"26-097","177Lu-DTPA-Omburtamab",{"date":37,"type":38},{"date":173,"type":38},"2026-07-02",{"date":175,"type":20},"2030-07-02",{"name":33,"class":44},{"id":178,"slug":4,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":72},"100470927","NCT05412225","A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer","Feasibility of Preoperative Radiotherapy in T3 and T4 Breast Cancer Patients Who Are Responders to Neoadjuvant Chemotherapy to Allow for Immediate Reconstruction: a Prospective Study","Inclusion Criteria:\n\n* Female sex, aged ≥18 years, with biopsy-proven invasive breast cancer\n* cT3-4 cN0-3 tumor\n* Partial or complete response to NAC on imaging and clinical examination using the Response Evaluation Criteria in Solid Tumors (RECISTv1.1) definition.\n* Desire to undergo autologous reconstruction and assessed to be an appropriate candidate by a plastic and reconstructive surgeon\n* Able to read and understand English\n\nExclusion Criteria:\n\n* Prior ipsilateral breast cancer\n* Bilateral breast cancer\n* Pregnant\n* Stage IV disease at presentation\n* Stable disease or progressive disease after NAC\n* Surgically unresectable breast disease\n* BMI \\>40\n* Prior history of thoracic radiotherapy",{"count":184,"type":20},60,[23],"The purpose of this study to test an alternative treatment approach that involves giving participants radiotherapy before their mastectomy (preoperative radiotherapy) and performing immediate reconstruction surgery at the time of mastectomy. The immediate reconstruction surgery is called an immediate autologous reconstruction (IR) and is different than the standard reconstruction surgery people with T4 breast cancer have. IR is a surgical procedure where immediately following your mastectomy, the surgeon takes tissue from another part of your body and uses it to re-create your breast. The standard reconstruction surgery occurs later and can be done with an implant or tissue from your body.\n\nThe main purpose of this study to find out if the alternative treatment approach shown above is feasible. The study will see how safe this alternative treatment approach is compared with the standard treatment approach.",[135,188],"Invasive Breast Cancer",[190,191,33,192],"breast cancer","mastectomy","22-136","2026-07-01",{"date":173,"type":38},{"date":196,"type":38},"2022-06-06",{"date":198,"type":20},"2027-06-06",{"name":33,"class":44},{"id":201,"slug":4,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":21,"phases":208,"briefSummary":209,"conditions":210,"keywords":214,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":224},"100434863","NCT04942717","Adapting for Latinx Populations an Intervention That Involves Discussing and Sharing Patients' Health-Related Values","Communicating With Oncology Nurses About Values From the Outset (CONVO): An Innovative Primary Palliative Care Intervention in English and Espanol","Inclusion Criteria:\n\n* All participants will be adults (age ≥ 21) providing informed verbal consent. We seek a waiver of signed consent, which will allow use of virtual communication during the COVID-19 pandemic period.\n* Patients will be eligible as key informants in the translation\u002Ftranscreation process (Aim 1) if they are receiving medical oncology care for a solid tumor malignancy at RLC, SBH, or Jacobi and speak Spanish as their preferred language. In addition, English-speaking Latinx patients will be eligible to participate in interviews based on the back-translated (Spanish-to-English) version of the Guide\n\n  * We are focusing on patients with solid tumors rather than hematologic malignancies because 1) patients in the latter group may be receiving initial oncologic treatment in the hospital, whereas our study staff will be based at a distance from the hospital in the ambulatory clinics; 2) the trajectory, patient characteristics, and other aspects of hematologic malignancies tend to be different from solid tumor malignancies such that it would be more difficult to understand the overall impact of the intervention if patients with both types of malignancies w ere included.\n* Spanish-speaking family\u002Fother informal caregivers (collectively referred to as \"family\") who accompany participating patients to clinic will also be eligible to participate in interviews as part of the Aim 1 translation\u002Ftranscreation process. These will be individual interviews, conducted separately for patient and family participants.\n* Clinicians eligible for participation in the transcreation will be oncology physicians, nurses and other key clinical staff (e.g. social workers, advance practice providers, etc.) at RLC and other MSK sites who are Latinx and\u002For whose practice includes \\>20% Latinx patients.\n* Site leaders at SBH, Jacobi, and RLC with administrative responsibility for medical oncology will be eligible as key informants in transcreation of CONVO.\n* For the Aim 2 pilot trial, patients will be eligible if they are receiving systemic chemotherapy at SBH or Jacobi for a solid tumor; identify as Latinx; and speak English and\u002For Spanish. Family and\u002For informal caregivers who accompany the patient and speak English and\u002For Spanish will also be eligible (if the patient opts to include the family and\u002For informal caregiver in the CONVO discussion).\n* Nurses providing outpatient oncology care in chemotherapy areas at SBH or Jacobi will be eligible to participate in the pilot trial.\n\nExclusion Criteria:\n\n* Inability to understand consent procedure in either English or Spanish will be an exclusion. (The consenting professional will be bilingual \\[English\u002FSpanish\\] and able to explain and obtain consent in either language.)",{"count":207,"type":20},234,[56],"The purpose of this study is to translate and tailor for Latinx participants a program called Communicating with Oncology Nurses about Values from the Outset (CONVO). In CONVO, routine cancer care for each participant includes a discussion between the nurse and participant about the participant's health-related values.",[211,212,213],"Solid Tumor","Solid Tumor, Adult","Solid Tumor, Unspecified, Adult",[215,216,211,217,33],"Spanish speaking","Latinx","20-539",{"date":173,"type":38},{"date":220,"type":38},"2021-06-18",{"date":222,"type":20},"2027-06-18",{"name":33,"class":44},5,{"id":226,"slug":4,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":231,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":150},"100361767","NCT03990428","Supportive Care Needs of Caregivers of People With Erdheim-Chester Disease and Other Histiocytic Diseases","A Study to Identify the Supportive Care Needs of Caregivers of Patients With Erdheim-Chester Disease and Other Histiocytic Diseases","Inclusion Criteria:\n\n* Self-identified informal caregiver (family member or friend who provides unpaid support) for a patient with Erdheim-Chester Disease (or LCH, RDD, or JXG for the exploratory aim).\n* Proficiency to complete study assessments in English, evaluated at the time of consent.\n* Age 18 or over.\n\nExclusion Criteria:\n\n* Participant unwilling to sign consent.\n* Participant unable to complete web-based assessments.",true,{"count":233,"type":20},250,"OBSERVATIONAL","This study is being done to answer the following question: What are the supportive care needs of informal caregivers of people with Erdheim-Chester disease and other histiocytic diseases?",[237],"Supportive Care Needs of Caregivers",[239,240,241,242],"Supportive care","Erdheim-Chester Disease","Other Histiocytic Diseases","19-213",{"date":173,"type":38},{"date":245,"type":38},"2019-06-14",{"date":247,"type":20},"2027-06",{"name":33,"class":44},{"id":250,"slug":4,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":266},"100617421","NCT07318402","Operator Radiation Exposure During Image-Guided Robotic-Assisted Bronchoscopy: A Multicenter Prospective Cohort Study","Inclusion Criteria:\n\n* Operator performing image-guided RAB on adult patients (age ≥18 years old)\n* A single participating operator per study site\n* Image-guided RAB procedure is planned for standard of care diagnostic sampling of a single parenchymal lung lesion at participating sites\n\nExclusion Criteria:\n\n* Operator refusal to participate\n* Image-guided RAB procedure performed on:\n\n  * Patients age \\\u003C18 years old\n  * Pregnant women\n  * Patients undergoing standard of care robotic assisted bronchoscopy with plan to sample \\>1 pulmonary parenchymal lesion\n  * Patients undergoing standard of care robotic assisted bronchoscopy for lesion localization (injection of dye\u002Fmarker or fiducial marker deployment)\n  * Patients undergoing standard of care robotic assisted bronchoscopy for a therapeutic intervention",{"count":255,"type":20},350,"This is a multicenter, single-arm, prospective, observational study designed to evaluate bronchoscopist radiation exposure during standard-of-care image-guided robotic-assisted bronchoscopy (RAB) for sampling of a single pulmonary parenchymal lesion.",[258],"Operator Radiation Exposure","2026-06-30",{"date":193,"type":38},{"date":262,"type":38},"2025-12-23",{"date":264,"type":20},"2028-12",{"name":33,"class":44},3,{"id":268,"slug":4,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":21,"phases":275,"briefSummary":276,"conditions":277,"keywords":292,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":72},"100472291","NCT05429970","A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)","Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study","Inclusion Criteria:\n\n* Advanced (stage II-IV) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma diagnosed on the basis of imaging, CA125, and clinical assessment\n* Scheduled to undergo exploratory laparotomy and PDS or IDS\n* Scheduled for surgery with at least 10 days of lead time, to allow the participant to take the β-blocker and COX2 inhibitor 7 days preoperatively\n* Age ≥18 years\n* ASA score of 1 to 3\n* Ability to understand the study objectives and procedures, comply with the protocol, and provide informed consent\n\nExclusion Criteria:\n\n* Chronic treatment with any β-blocker or COX inhibitor\n* Contraindication for β-blocker therapy (asthma, second- or third-degree atrioventricular block, sinus bradycardia, sick sinus syndrome, right-sided heart failure, pheochromocytoma, peripheral vascular disease)\n* Contraindication for COX2 inhibitor therapy (renal failure \\[creatinine level \\>1.5 mg\u002FdL\\], significant liver failure \\[known cirrhosis, bilirubin level \\>2\\], active peptic disease), or current use of oral anticoagulant)\n* Contraindication for regional epidural anesthesia\n* Chronic autoimmune disease\n* Active infection\n* Pregnant\n* Minimally invasive procedure\n* Participation in another clinical trial that interferes with this study",{"count":274,"type":20},35,[56],"The purpose of this study is to see if propranolol and etodolac along with mind-body resilience training\u002FMBRT and music therapy help participants who are experiencing physiological stress before, during, and after primary debulking surgery\u002FPDS or IDS and also if it's better than the standard-of-care approach (no intervention for reducing stress).",[278,279,280,281,282,283,284,285,286,287,288,289,290,291],"Ovarian Cancer","Ovarian Carcinoma","Stage II Ovary Cancer","Stage II Ovarian Cancer","Stage III Ovary Cancer","Stage III Ovarian Cancer","Stage IV Ovary Cancer","Stage IV Ovarian Cancer","Epithelial Ovarian Cancer","Fallopian Tube Cancer","Stage II Fallopian Tube Cancer","Stage III Fallopian Tube Cancer","Stage IV Fallopian Tube Cancer","Primary Peritoneal Carcinoma",[293,294,295,296,297,298,286,287,291],"ovarian cancer","propranolol","etodolac","MBRT","mind-body resilience training","music therapy",{"date":193,"type":38},{"date":301,"type":38},"2022-06-17",{"date":303,"type":20},"2027-06-17",{"name":33,"class":44},{"id":306,"slug":4,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":231,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":21,"phases":313,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":150},"100434392","NCT04936529","A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma","Phase II Trial of a Bivalent Vaccine With the Immunological Adjuvant OPT-821 (QS-21), in Combination With Oral β-glucan and Randomization of GM-CSF, for High-risk Neuroblastoma","Inclusion Criteria:\n\n* Diagnosis of NB as defined by international criteria, i.e., histopathology (confirmed by the MSK Department of Pathology) or BM metastases plus high urine catecholamine levels or positivity in MIBG scan\n* HR-NB as defined by risk-related treatment guidelines and international criteria,i.e., metastatic\u002Fnon-localized disease with MYCN amplification (any age), MYCN-non-amplified metastatic disease \\>18 months old, MYCNamplified localized disease (any age), or disease resistant to standard chemotherapy.\n* HR-NB (as defined above) and in 1) first CR at ≥ 6 months from initiation of immunotherapy using anti-GD2 antibody, or 2) second or subsequent CR (achieved after treatment for PD). CR is defined according to the International Neuroblastoma Response Criteria.Patients with positive MIBG scan but negative FDG-PET scan, and CR in BM, are eligible.\n* Patients with grade 3 toxicities or less using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA (CTCAE v5.0) related to hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam.\n* Hematologic Function\n\n  * Absolute neutrophil count (ANC) ≥ 500\u002Fmcl\n  * Absolute lymphocyte count ≥ 500\u002Fmcl\n  * Hemaglobin (Hgb) ≥ 8 g\u002FdL\n  * Platelet count ≥ 50,000 mm\\^3\n* Renal Function o Serum creatinine ≤ 3.0 x ULN\n\nor\n\n* eGFR \\>60 mL\u002Fmin\u002F1.73 m\\^2\n\n  \\- Hepatic Function\n* Serum bilirubin ≤ 3.0 × ULN\n* Aspartate transaminase (AST) ≤ 5.0 × ULN\n* Alanine aminotransferase (ALT) ≤ 5.0 × ULN\n\n  * Prior treatment with other immunotherapy, including mAbs or vaccine, is allowed but must be completed ≥ 21 days before the 1st vaccination.\n\nNote: Prior treatment with an investigational therapy must be completed ≥ 28 days before the 1st vaccination.\n\n* ≥ 21 and ≤ 180 days between completion of systemic therapy and 1st vaccination.\n* Patients have recovered from any toxicities grade 3 or higher caused by prior therapies.\n* Patients previously enrolled on this trial are eligible for repeat enrollment if they did not complete all vaccine injections during the first time on protocol but they will be assigned to Group 3 and will not be included in the primary biostatistical analyses.\n* A negative pregnancy test is required for patients w ith child-bearing capability.\n* Signed informed consent indicating awareness of the investigational nature of this program.\n\nExclusion Criteria:\n\n* Patients w ith significant (grade \\>4) hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam, using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA (CTCAE v5.0)\n* History of allergy to KLH, QS-21, OPT-821, or glucan.\n* Active life-threatening infection requiring systemic therapy.\n* Inability to comply with protocol requirements.\n* Patients with history of allergy to GM-CSF or who are unable to obtain GM-CSF because of insurance issues are ineligible",{"count":312,"type":20},286,[107],"The purpose of the study is to explore the combination of a bivalent vaccine, a sugar called beta-glucan (β-glucan), and a protein called granulocyte-macrophage colony stimulating factor (GM-CSF) as an effective treatment for people with high-risk neuroblastoma that is in complete remission. The combination may be effective because the different parts of the treatment work to strengthen the immune system's response against cancer cells in different ways.",[316],"Neuroblastoma",[316,318,319,320,321,322,33,323],"High-risk Neuroblastoma","OPT-821","QS-21","β-glucan","GM-CSF","21-206","2026-06-29",{"date":259,"type":38},{"date":327,"type":38},"2021-08-02",{"date":329,"type":20},"2027-06-15",{"name":33,"class":44},{"id":332,"slug":4,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":16,"minAge":337,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":21,"phases":339,"briefSummary":340,"conditions":341,"keywords":343,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":354},"100623699","NCT07400029","A Study of Obecabtagene Autoleucel in People With B-cell Acute Lymphoblastic Leukemia","A Phase II Trial of Obecabtagene Autoleucel Consolidation in Adult Patients With Acute Lymphoblastic Leukemia in First Complete Remission Without Measurable Residual Disease","Inclusion Criteria:\n\n* Diagnosis of CD19+ B-cell ALL.\n\n  * Both Ph-negative and Ph-positive are allowed\n  * Patients with EMD must have detectable disease in the bone marrow (by flow cytometry or molecular methods) in order to follow MRD.\n* Patients aged ≥ 40 years at time of screening A.\n* Patients aged 30-39 years (at time of Screening A) are allowed in the presence of high-risk comorbidities or poor tolerability of chemotherapy (e.g. history or experienced pancreatitis with therapy, BMI ≥40kg\u002Fm2, underlying liver disease precluding safer administration of pediatric inspired regimens, any further combination of documented severe comorbidities that the investigator judges to be incompatible with administering an intensive pediatric or pediatric-inspired standard chemotherapy regimen).\n* In MRD negative CR or CR with incomplete hematologic recovery (CRi) at the time of screening. MRD will be assessed by flow cytometry and\u002For molecular testing such as ClonoSEQ at the minimum sensitivity of 10-4 from the bone marrow. Patients with MRD \\\u003C10\\^-4 will be eligible.\n* Patients may receive more than one course of upfront induction and\u002For consolidation, but must be in MRD- CR\u002FCRi at time of screening, within 4 months from initiation of treatment. The 4-month window will be measured from the first day of anti-leukemic therapy initiation (excluding steroid prophase) until the Screening A test for the trial.\n\nFrontline regimens include but are not limited to:\n\n* HyperCVAD or mini-hyper-CVD\n* Asparaginase-containing multiagent chemotherapy (e.g. CALGB10403, pediatric inspired chemo)\n* Inotuzumab or blinatumomab with or without chemotherapy\n* Tyrosine kinase inhibitor plus steroids, chemotherapy, or blinatumomab\n\n  \\- Adequate organ function at time of screening A, including:\n* ALT or AST ≤5x ULN and total bilirubin ≤2 (or ≤3 if history of Gilbert's syndrome or leukemic infiltration of the liver)\n* Serum creatinine \\\u003C2.0mg\u002FdL\n* SaO2 ≥92% on room air\n* Left ventricular ejection fraction (LVEF) ≥50% within 1 month of screening\n\n  * ECOG performance status 0-2\n  * CD19 expression is required at any time since diagnosis. CD19 expression may be detected by immunohistochemistry or by flow cytometry. Patients receiving prior blinatumomab are eligible if there is no documentation of CD19-negative disease after blinatumomab.\n  * CNS1 status must be documented at time of screening by CSF assessment. Patients with prior CNS2 or CNS3 disease must be CNS1 at screening and have no residual CNS deficits or symptoms.\n  * Patients will need to adhere to institutional contraception guidelines for a minimum of 1 year.\n  * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n\nExclusion Criteria:\n\n* Burkitt's leukemia or lymphoma\n* Patients with measurable extramedullary disease at screening are excluded. Patients with prior history of extramedullary disease are allowed after documentation of disease resolution by either PET\u002FCT scan (or CT with contrast if PET cannot be performed).\n* The following medications are excluded:\n\n  * Steroids: Therapeutic doses of corticosteroids (greater than 10mg daily of prednisone or its equivalent) within 7 days of leukapheresis or 72 hours prior to CAR T cell infusion.\n  * Systemic chemotherapy: Must be discontinued 7 days prior to leukapheresis or 7 days prior to starting lymphodepleting chemotherapy if used during bridging.\n  * Tyrosine kinase inhibitors: Must be discontinued 48 hours prior to apheresis and 48 hours prior to starting lymphodepleting chemotherapy, if used during bridging.\n  * Blinatumomab must be discontinued 5 days before apheresis\n  * Inotuzumab must be discontinued 2 weeks before apheresis to allow T cell recovery\n* Patients with uncontrolled systemic fungal, bacterial, viral or other infection at time of leukapheresis or at time of CAR T cell infusion\n* Blinatumomab may not be used as bridging therapy following apheresis\n* Positive test indicating the presence of active infection with the following pathogens: HIV, Hepatitis B (detectable Hep B DNA by PCR or Hep B surface antigen), Hepatitis C (detectable Hep C RNA by PCR), HTLV, Syphilis. The tests required will be agreed upon with the manufacturer to comply with manufacturer's regulatory and manufacturing requirements.","40 Years",{"count":19,"type":20},[107],"The researchers are doing this study to find out whether obecabtagene autoleucel (obe-cel) is an effective treatment for people with B-cell acute lymphoblastic leukemia (ALL) that is in complete remission (CR, meaning all signs of cancer are gone) with no measurable residual disease (MRD-negative, meaning there are no detectable cancer cells). Participants in this study will have received past treatment for their B-cell ALL, and their disease will be in MRD-negative CR for the first time (first MRD-negative CR).",[342],"Acute Lymphoblastic Leukemia",[344,345,346],"Obecabtagene Autoleucel","B-cell","25-342","2026-06-26",{"date":324,"type":38},{"date":350,"type":38},"2026-02-03",{"date":352,"type":20},"2029-02",{"name":33,"class":44},8,{"id":356,"slug":4,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":21,"phases":361,"briefSummary":362,"conditions":363,"keywords":365,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":72},"100602515","NCT07124520","Normative Ranges of Lingual Strength and Endurance and the Impact of the IOPI Lingual Strength Trainer on Quantitative Functional Outcomes and Patient-Reported Outcomes After Partial Glossectomy or Hemiglossectomy for Oral Tongue Cancer, An Unblinded: Randomized Pilot Study","Inclusion Criteria:\n\n* Age ≥18 years old\n* Scheduled to undergo primary surgery for oral tongue cancer (glossectomy types 1 to 3) using any type of closure or reconstruction\n\nExclusion Criteria:\n\n* Previous radiation therapy to the oral cavity or head and neck\n* Previous surgery for oral cavity cancer\n* Recurrent oral cavity cancer\n* Surgical requirement of extension to involve bone (mandible resection)\n* Subtotal or total glossectomy\n* Feeding tube dependance prior to surgery",{"count":184,"type":20},[56],"The purpose of this study is to learn more about tongue strength and endurance by using the Iowa Oral Performance Instrument (IOPI). The IOPI is a device that measures tongue pressure.",[364],"Tongue Cancer",[364,366,367,368,369,33,370],"Oral Tongue Cancer","IOPI Lingual Strength Trainer","Iowa Oral Performance Instrument","Iowa Oral Performance Instrument Tongue Strength Trainer","25-162",{"date":259,"type":38},{"date":373,"type":38},"2025-08-07",{"date":375,"type":20},"2028-08-07",{"name":33,"class":44},{"id":378,"slug":4,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":21,"phases":385,"briefSummary":386,"conditions":387,"keywords":390,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":400},"100333226","NCT03618550","Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma","Phase II Study of Second-line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma","Inclusion Criteria:\n\n* Histologic diagnosis of classical Hodgkin's lymphoma. Primary refractory or relapsed disease proven by biopsy at enrolling institution.\n* Stage I-III Hodgkin lymphoma (part 3)\n* Relapse or refractory disease following 1 line of multi-agent chemotherapy (not including pembro-GVD).\n* Eligible for HDT\u002FASCT\n* Achieved complete response (Deauville 3 or better) per clinical review following 2 cycles of pembro-GVD\n* Be willing and able to provide written informed consent\u002Fassent for the trial.\n* Be ≥ 18 years of age on day of signing informed consent.\n* Have measurable disease based on Lugano 2014 criteria\n* Have a performance status of 0 or 1 on the ECOG Performance Scale\n* Demonstrate adequate organ function as defined in table below\n* Demonstrate adequate organ function as defined in table below. Hematological\\*\n* Absolute neutrophil count (ANC) ≥1000 \u002FmcL\n* Platelets ≥50,000 \u002F mcL\n* Hemoglobin ≥8 g\u002FdL Renal\n* Serum creatinine OR ≤1.5 X upper limit of normal (ULN) OR\n* Measured or calculated creatinine clearance (eGFR can also be used in place of creatinine) ≥60 mL\u002Fmin for subject with creatinine levels \\> 1.5 X institutional ULN Hepatic\\*\n* Serum total bilirubin ≤ 1.5 X ULN OR ≤ 3 X ULN for subjects with liver metastases\n* AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases Pulmonary\n* Hemoglobin-adjusted diffusing capacity for carbon monoxide ≥50% (If unadjusted DLCO is \\>\u002F= 50% then there is no need to calculate adjusted) Cardiac\n* Ejection fraction ≥45% Coagulation\n* International normalized ratio (INR) OR prothrombin time (PT), Activated partial thromboplastin time (aPTT): ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\n  \\*Lab values for eligibility should be based upon labs prior to Cycle 1 treatment of Pembro-GVD.\n* Female subject of childbearing potential should have a negative urine or serum pregnancy within 2 weeks prior to receiving the first dose of study medication. On the day of planned treatment, if a blood pregnancy test has not been performed within the two week window, a stat pregnancy test (urine or blood) should be performed and the results reviewed before treatment is begun.\n* Female subjects of childbearing potential must be willing to use an adequate method of contraception (see details in section 11.4.3).\n* Male subjects of childbearing potential must agree to use an adequate method of contraception.(see details in section 11.4.3).\n* HIV-infected participants must have well-controlled HIV on ART, defined as:\n\n  * Participants on ART must have a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n  * Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies\u002FmL or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening\n  * It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n  * Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study\n* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.\n\nExclusion Criteria:\n\n* Received more than 1 prior treatment (combined modality therapy represents 1 treatment) for Hodgkin Lymphoma\n* Known pregnancy or breast-feeding.\n\n  * Breast-feeding should be discontinued prior to treatment initiation.\n* Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the attending physician and\u002For principal investigator, makes participation in this study inappropriate.\n* Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Has known active HIV, Hepatitis B (e.g., Hepatitis B PCR positive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Has not adequately recovered from major surgery or has ongoing surgical complications\n* Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Subjects who have had an allogeneic hematopoietic transplant greater than 5 years ago are eligible as long as there are no symptoms of GVHD.)\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.",{"count":384,"type":20},257,[107],"The purpose of this study is to test any good and bad effects of the study drug, pembrolizumab, in combination with GVD in the treatment of Hodgkin lymphoma.",[388,389],"Hodgkin Lymphoma","Relapsed or Refractory Hodgkin Lymphoma",[391,392,393],"Pembrolizumab","GVD","18-160",{"date":324,"type":38},{"date":396,"type":38},"2018-08-01",{"date":398,"type":20},"2026-08",{"name":33,"class":44},10,{"id":402,"slug":4,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":21,"phases":408,"briefSummary":409,"conditions":410,"keywords":414,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":72},"100633916","NCT07532902","A Study of BMS-986504 With Standard-of-Care Therapy for People With Solid Tumor Cancer","A Phase 1a\u002F1b Basket Trial of BMS-986504 With Standard-of-Care Therapy For Patients With Select Metastatic MTAP-deleted Solid Tumors","Inclusion Criteria:\n\n* Documentation of Disease:\n* Patients must have pathologic confirmation of one of three diseases:\n* Diffuse pleural mesothelioma (DPM)\n* Gastroesophageal carcinoma (GEC) including adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction, or stomach.\n* PD-L1 CPS ≥1 (using clone 73-10, DAKO)\n* HER2 overexpression negative (using clone 4B5, Ventana): HER2 IHC 0-1+, or HER2 2+ with ISH showing HER2:CEP17 ratio \\\u003C2 and average HER2 copy number \\\u003C6.0 signals\u002Fcell\n* Urothelial carcinoma (UC)\n* Archival tissue is acceptable\n* Metastatic or advanced\u002Funresectable disease:\n* For Diffuse Pleural Mesothelioma (DPM) and Gastroesophageal Carcinoma (GEC )cohorts: no prior systemic treatment for metastatic disease\n* Patients with metastatic disease after treatment for localized GEC may have received prior systemic therapy (chemotherapy and\u002For chemoradiation) if \\>6 months have elapsed between the end of therapy and registration.\n* One prior cycle of standard-of-care therapy alone without BMS-986504 or other MTAP inhibitors (ipi\u002Fnivo for DPM, FOLFOX + nivo for GEC) is acceptable with PI approval.\n* For UC cohort: must have received at least 1 prior line of treatment without prior gemcitabine (prior tx with Gem+Platinum in the perioperative setting is permitted if at least 12 months have elapsed from trial enrollment)\n* Patients with recurrent disease within 1 year of completion of prior perioperative systemic therapy are eligible with PI approval.\n* One prior cycle of standard-of-care therapy alone with gemcitabine + platinum, without BMS-986504 or other MTAP inhibitors, is acceptable with PI approval.\n* Confirmation of MTAP deletion by either IHC or NGS:\n* MTAP deletion must be detected by either IHC and\u002For NGS (including FACETS), done on tumor tissue (not blood):\n* IHC (using antibody 1813, NBP2-75730, Novus Biologicals)30\n* IHC staining showing loss of MTAP expression\n* Tissue-based NGS options\n* MSK-IMPACT version 7 or beyond showing homozygous MTAP copy number loss\n* FACETS showing homozygous deletion\n* Other CLIA-approved commercial Template Version: 1-21-25\n* Full report must be available for review and confirmation\n* Cases with discordant results between NGS and IHC, in which one test shows MTAP loss\u002FMTAP del and the other shows MTAP intact, are acceptable with PI approval\n* Measurable disease per RECIST v 1.1 (or, for DPM cohort, by either RECIST v 1.1 or modified RECIST \\[mRECIST\\] for mesothelioma31)\n* No contraindications to receiving other standard-of-care agents per package inserts (and see Appendix IV), and per the discretion of the PI:\n* DPM: Ipilimumab + nivolumab\n* GEC: FOLFOX (5-FU, leucovorin, and oxaliplatin) + nivolumab\n* UC: Gemcitabine + platinum (carboplatin or cisplatin)\n* Age ≥ 18\n* KPS ≥ 70\u002FECOG \\\u003C1\n* Reproductive Status:\n* Female participants of child-bearing potential (as assigned at birth) must have a negative highly sensitive urine or serum (as required by local regulations) pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study intervention.\n* If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n* Female participants of child-bearing potential (as assigned at birth) must agree to use a combination of a hormonal and a non-hormonal contraceptive method or a non-hormonal method alone that is highly effective (with a failure rate of \\\u003C 1% per year)during the intervention period and for 14 months (for females) after the last dose of study intervention (or longer if required by institutional guidelines) Hormonal contraceptive methods alone are not allowed.\n* Female participants of child-bearing potential (as assigned at birth) must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period.\n* If needed, these participants should be advised to seek advice about egg donation and cryopreservation of germ cells before treatment.\n* Female participants (as assigned at birth) are deemed to be without child-bearing potential if they meet one of the following criteria:\n* Postmenopausal for at least 1 year before the screening visit\n* Permanently sterile (undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy) with surgery at least 1 month before the first dose of study drug or confirmed by follicle stimulating hormone (FSH) test \\> 40 mIU\u002FmL and estradiol \\\u003C 40 pg\u002FmL (\\\u003C140 pmol\u002FL)\n* Male participants (as assigned at birth) will be required to always use a latex or other synthetic condom during any sexual activity (eg, vaginal, anal, oral) with a female of childbearing potential, even if the participant has undergone a successful vasectomy or if the partner is pregnant or breastfeeding. Male participants (as assigned at birth) should continue to use a condom during the intervention period and for at least 11 months after the last dose of study intervention (or longer if required by institutional guidelines).\n* Male participants must refrain from donating sperm during the intervention period and for at least 11 months after the last dose of study intervention (or longer if required by institutional guidelines).\n* If needed, male participants should be advised to seek advice about sperm donation and cryopreservation of germ cells before treatment.\n* Individuals of child-bearing potential who are partners of male participants should be advised to use a highly effective method of contraception during the intervention period and for at least 11 months after the last dose of study intervention for the male participant\n* Male participants (as assigned at birth) with a pregnant or breastfeeding partner must agree to remain abstinent from sexual activity or use a male condom during any sexual activity (eg, vaginal, anal, oral), even if the participant has undergone a successful vasectomy, during the intervention period and for at least 11 months after the last dose of study intervention\n* Breastfeeding partners of male participants (as assigned at birth) should be advised to consult their health care provider about using appropriate highly effective contraception during the time the male participant is required to use condoms\n* Recovery from the adverse effects of prior therapy at the time of enrollment to baseline or ≤ Grade 1 (excluding alopecia, peripheral neuropathy, and parameters superseded by other eligibility criteria \\[eg, hematology parameters\\]). Note: Participants with prior endocrine adverse effects are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n* Required organ function\n* Adequate hematologic function defined as follows:\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm3\n* Hemoglobin ≥ 8 g\u002Fdl\n* Adequate renal function defined as follows:\n* Creatinine clearance (CrCL) of ≥50 mL\u002Fmin by the CKD-Epi creatinine equation\n* Adequate hepatic function defined as follows:\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)\n* AST and ALT ≤5 x ULN\n* Signed informed consent form (ICF)\n\nExclusion Criteria:\n\n* Prior treatment with PRMT5i or MAT2Ai\n* Symptomatic CNS metastases\n* Patients with treated brain metastases are eligible if follow up brain imaging after CNS directed therapy shows no evidence of progression and the patient is on a stable dose of corticosteroids\n* Received palliative radiation therapy within 3 days prior to initiation of study treatment or definitive SRS including CNS SRS within 14 days prior to initiation of study treatment\n* Patients who have had major surgery within 3 weeks of start of study drug\n\n  o Note: procedures such as biopsy, pleural catheter insertion, central venous catheter or other minor procedures are permitted\n* Any of the following cardiac abnormalities:\n* Unstable angina pectoris or myocardial infarction within 6 months prior to enrollment\n* Congestive heart failure ≥ NYHA Class 3 within 6 months prior to enrollment\n* Prolonged QTc \\> 500 milliseconds or history of Long QT Syndrome\n* Child-Pugh class C liver cirrhosis\n* Ongoing medical illness not otherwise listed which would preclude study at the discretion of the PI\n* Inability to take medications PO (BMS-986504 cannot be taken via gastrostomy tube), refractory nausea and vomiting, malabsorption, biliary shunt, significant bowel resection, or any other condition that significantly affects gut motility or absorption and would preclude adequate absorption of BMS-986504 in the opinion of the treating physician and\u002For PI\n* Ongoing need for a medication that is a strong inhibitor or strong inducer of cytochrome P450 (CYP) 3A4 and\u002For P-glycoprotein (P-gp) or proton-pump inhibitor that cannot be switched to alternative treatment prior to study entry\n* HIV, HBV, or HCV with detectable viral load\n* For patients with known HIV, HBV, and\u002For HCV infection:\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable with or without suppressive therapy\n* Patients with a history of HCV infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Active infection requiring parenteral antibiotic(s)\n* Pregnant or breastfeeding\n* Presence of another malignancy that could be mistaken for the malignancy under study during disease assessments.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.",{"count":184,"type":20},[23],"The researchers are doing this study to test the safety of BMS-986504 in combination with standard disease-specific anticancer medication in people with metastatic\u002Fadvanced unresectable MTAP-deleted solid tumor cancer.",[411,412,413],"Diffuse Pleural Mesothelioma","Gastroesophageal Carcinoma","Urothelial Carcinoma",[415,416,417,418,419,420,421,422,423,424],"BMS-986504","Metastatic MTAP-deleted Solid Tumors","Ipilimumab","Nivolumab","5-fluorouracil","Leucovorin","Oxaliplatin","Gemcitabine","Carboplatin","Cisplatin","2026-06-25",{"date":324,"type":38},{"date":428,"type":38},"2026-04-07",{"date":430,"type":20},"2029-04",{"name":33,"class":44},{"id":433,"slug":4,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":21,"phases":440,"briefSummary":441,"conditions":442,"keywords":446,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":354},"100593443","NCT07006506","A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant","Phase II Open Label Prospective Nonrandomized Trial of Belumosudil for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria:\n\n* Patients ≥ 18 years-old at time of consent.\n* Diagnosis: hematologic malignancy in morphologic remission who will be treated with RI or NMA conditioning and GVHD prophylaxis CNI-based (CNI without PTCY) plus abatacept or PTCY-based (CNI with PTCY).\n* Recipients of 7-8\u002F8 related or unrelated HLA-matched or related haploidentical donor.\n* Peripheral blood stem cell graft\n* Allo-HCT day \\\u003C120 at time of consent\n\nPost-HCT inclusion criteria (within 3 weeks before start of belumosudil treatment)\n\n* Patient has received an allo-HCT transplant and is in morphologic remission (blasts \\\u003C5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are allowed.\n* Patient has achieved engraftment. Engraftment is defined as ANC≥500\u002FμL and platelets ≥ 20000\u002FμL on 3 consecutive measurements (each occurring at least 1 day apart). The patient must not have had a platelet transfusion within 7 days before the first measurement.\n* Patient is ≥ 80 days and ≤ 20 days from allo-HCT infusion.\n* Karnofsky score ≥ 70%.\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN)\n* Total bilirubin ≤1.5 x ULN (unless benign congenital hyperbilirubinemia).\n* Glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin\u002F1.73 m2\n* Female subjects of childbearing potential (≤ 50 years old) have a negative serum or urine pregnancy test. Females of childbearing potential are defined as females without prior hysterectomy or who have had any evidence of menses in the past 12 months.\n\n  ° Sexually active females of childbearing potential enrolled in the study must agree to consistently use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control includes: \\* Intrauterine device (IUD) plus one barrier method \\* Stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method \\* 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gel that contain a chemical to kill sperm); or \\* A vasectomized partner\n* For male subjects who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug.\n\nExclusion Criteria:\n\n* Recipient of CD34+ selected or engineered stem cell graft.\n* Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin).\n* Evidence of current uncontrolled cardiovascular conditions, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.\n* Pulmonary dysfunction with DLCO \\\u003C50% corrected for hemoglobin\n* Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 5 years. Exceptions include adequately treated localized non melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance.\n\nPost-HCT exclusion criteria\n\n* Uncontrolled infection, including active hepatitis B and C. Definitive therapy for infection is required and must have no signs of progression within 7 days of the first day of study drug treatment.\n* Use of investigational agent within 14 days pre-HCT or anytime thereafter.\n* Active acute or chronic GVHD requiring systemic therapy (topical or local therapies are allowed).\n* Active treatment with corticosteroids at a dose of ≥ 0.25 mg\u002Fkg\u002Fday for non-GVHD indication.\n* Uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year\n* Female patient who is pregnant or breastfeeding.\n* Prior therapy with belumosudil.\n* Known allergy or sensitivity to belumosudil or any other ROCK2 inhibitor.",{"count":439,"type":20},46,[107],"The purpose of this study is to find out whether adding belumosudil to a usual approach for reducing the risk of graft-versus-host disease (GVHD) may be an effective GVHD prevention approach for people with blood cancer who have a stem cell transplant. The investigators will also look at the safety of the study approach.",[443,444,445],"Graft Versus Host Disease","Graft Vs Host Disease","Hematologic Malignancy",[443,444,445,447,448,449,33,450],"Hematologic malignancy in morphologic remission","Belumosudil","Stem Cell Transplant","25-033",{"date":324,"type":38},{"date":453,"type":38},"2025-05-21",{"date":455,"type":20},"2029-05-21",{"name":33,"class":44},{"id":458,"slug":4,"hasResults":11,"nctId":459,"briefTitle":460,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":462,"targetDuration":464,"studyType":234,"phases":4,"briefSummary":465,"conditions":466,"keywords":468,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":72},"100476887","NCT05489783","Glioma Developmental and HyperActive Ras Tumor (DHART) Board","Inclusion Criteria:\n\n* Clinical diagnosis that meets NIH criteria for NF1 disease by either 1) documented clinical record establishing NF1 or 2) self-reported with supported documentation upon medical record collection.\n* Willing to have historical and future NF1 related health records sent to registry for review.\n* Radiologic or pathologically confirmed glioma.\n* Individuals ≥18 years of age on the date of informed consent.\n\nExclusion Criteria:\n\n* Unwillingness to sign informed consent.\n* No proficiency in English or Spanish as determined by the Investigator.",{"count":463,"type":20},50,"5 Years","This study will collect medical records, scan results, and complete surveys to create a registry about people with a neurofibromatosis type 1-associated brain tumor (NF1-associated glioma). A registry is a collection of health information about individuals, and it is usually focused on a specific diagnosis or condition.\n\nThis registry study will help the researchers learn more about the diagnosis, treatment, and quality of life of people with NF1-associated glioma. The researchers want to understand what happens as a result of different treatments for NF1-associated glioma and how these treatments and the disease itself affect people's lives over a period of time. Information collected during this study could affect how doctors diagnose, test, and treat NF1-associated glioma, and the study could help future patients with this type of cancer.",[467],"Glioma",[469,470,471,472],"NF1-associated glioma","Neurofibromatosis","Registry","22-199",{"date":324,"type":38},{"date":475,"type":38},"2022-07-29",{"date":477,"type":20},"2026-07-31",{"name":33,"class":44},{"id":480,"slug":4,"hasResults":11,"nctId":481,"briefTitle":482,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":231,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":486,"conditions":487,"keywords":488,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":45},"100472947","NCT05438511","A Formative Evaluation For Improving Breast Cancer Hormone Receptor Testing in Tanzania","Participant Inclusion Criteria for interviews and focus group discussions (Aims 1 and 2):\n\n* Breast cancer survivor, patient advocate or key healthcare personnel\n\n  * Key healthcare personnel are defined as hospital and laboratory leaders, pathologists, laboratory scientists and technicians, oncologists, nurses, and surgeons, with:\n  * \\>12 months of employment at the affiliated institution\n  * Administrative or clinical involvement in the delivery of breast cancer care services.\n* Age 18 years and above\n* Permanent residents or citizens of Tanzania\n* Participant and\u002For LAR willing and able to consent\n* Fluent in Swahili and\u002For English by self-report\n\nParticipant Exclusion Criteria:\n\n* Key stakeholder not residing at their particular institutions during data collection will be excluded.\n\nEligibility criteria for Chart Reviews (Aim 1)\n\nInclusion Criteria for chart review:\n\n* Age 18 years and above\n* Permanent residents or citizens of Tanzania\n* Received breast cancer diagnosis\n\nExclusion Criteria for chart review:\n\n* Participants less than 18 years of age",{"count":485,"type":20},85,"The purpose of this study is to learn more about the challenges with breast cancer diagnosis in Tanzania and the support available to improve this process.",[135],[489,490,491,33,492],"breast cancer hormone receptor testing","breast cancer testing","GeneXpert STRAT4","21-480",{"date":324,"type":38},{"date":495,"type":38},"2023-04-13",{"date":497,"type":20},"2027-04",{"name":33,"class":44},{"id":500,"slug":4,"hasResults":11,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":11,"sex":505,"minAge":17,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":21,"phases":507,"briefSummary":508,"conditions":509,"keywords":510,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":521,"locationsCount":522},"100551271","NCT06457919","A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer","A Phase 1b\u002F2 Study Evaluating the Activity of Tinengotinib (TT-00420) in Combination With Androgen Receptor Signaling Inhibitors (ARSIs) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)","Inclusion Criteria:\n\n* Participants ≥ 18 years old, with signed informed consent\n* Histologically confirmed carcinoma of the prostate (neuroendocrine differentiation is allowed, but pure small cell carcinoma is not permitted)\n* Metastatic disease documented by at least 2 bone lesions on whole body radionuclide bone scan, or soft tissue disease documented by computed tomography (CT) scan\u002Fmagnetic resonance imaging (MRI). Note: Metastatic disease seen only on PET imaging does not qualify.\n* Current ongoing therapy and observed tolerance with full standard dose of abiraterone acetate (1000 mg QD) or enzalutamide (160 mg QD) at the time of study entry. Enzalutamide or abiraterone acetate must have been started at least 90 days before screening assessments. An interruption of dosing of a maximum of 30 days is permitted prior to resuming the agent. Please note: Patients who are on a reduced dose or are intolerant of abiraterone acetate or enzalutamide at screening will not be eligible for study participation.\n* Progressive disease on enzalutamide or abiraterone acetate documented by PCWG3 criteria for study entry. Progressive disease is defined as at least one of the following:\n\n  1. PSA progression defined as a minimum of 2 rising PSA levels with a minimum of a 1-week interval between each determination, reaching a minimum PSA value of 1.0 ng\u002FmL.\n  2. Nodal or visceral progression as defined by PCWG3-modified RECIST 1.1\n  3. Appearance of 2 or more new lesions on a bone scan\n* At least one of the following at study entry:\n\n  1. RECIST 1.1 measurable disease at baseline; i.e., soft tissue tumor lesions or pathologically enlarged lymph nodes that can be accurately measured in at least one dimension OR\n  2. a PSA of 2.0 ng\u002FmL or above\n* Participants must be medically or surgically castrated with ongoing androgen deprivation therapy (ADT) for ≥90 days or have documented history of bilateral orchiectomy.\n* ECOG 0 - 2\n* Adequate organ function confirmed at screening, as evidenced by:\n\n  * Absolute neutrophil count ≥ 1.5 × 10\\^9 \u002FL\n  * Hemoglobin ≥ 9 g\u002FdL\n  * Platelets ≥ 75 × 10\\^9 \u002FL\n  * Aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5.0 × ULN if liver metastases are present\n  * Total bilirubin ≤ 1.5 × ULN; or \\\u003C 2.5 × ULN if Gilbert syndrome or disease involving liver\n  * Creatinine clearance \\>30 mL\u002Fmin (Cockcroft-Gault formula)\n  * Adequate blood coagulation function as evidence by an international normalized ratio (INR) ≤ 1.5 unless participant is on anticoagulants\n* Tumor biopsy during screening is required if safe and feasible. If archival tissue is available from a previous biopsy performed within 90 days of screening assessments, a repeat screening biopsy is not required even if safe and feasible. If neither option is possible, archival tissue from any timepoint should be requested, if available.\n\nExclusion Criteria:\n\n* The presence of any of the following criteria excludes a patient from participating in the study:\n* Pure small cell carcinoma\n* Previous exposure to multi-TKI therapies.\n* Uncontrolled hypertension (persistent systolic blood pressure ≥ 140 mm Hg and\u002For diastolic blood pressure ≥ 90 mm Hg) or known coronary artery disease with angina. Patients with known hypertension must be on antihypertensive medication with BPs generally \\\u003C140\u002F90 to be eligible.\n* History of congestive heart failure of Class II-IV New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months of study entry, or prolongation of QTc interval to \\>480 msec using Fridericia formula (QTcF) at screening (except for participants with pacemakers, where there is no QTc cutoff).\n* Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessments.\n* Symptomatic and\u002For untreated CNS metastases.\n* Pre-existing duodenal stent or any gastrointestinal disorder or defect which would interfere with absorption of study medication, as determined by the Investigator.\n* Persistent requirement for corticosteroids at equivalent of \\>10 mg QD prednisone within 14 days before study treatment start.\n* Other anticancer therapies within 3 weeks of study treatment start, or within 5 half-lives of study treatment start for non-cytotoxic oral agents, whichever is shorter; with the exception of androgen deprivation therapy, enzalutamide, or abiraterone acetate which should be continued through study treatment.\n* Palliative radiation within 2 weeks of study treatment start.","MALE",{"count":463,"type":20},[23,107],"The purpose of this study is to find out whether tinengotinib in combination with abiraterone acetate and prednisone or enzalutamide is a safe treatment that causes few or mild side effects in people with metastatic castration-resistant prostate cancer (mCRPC).",[138],[511,512,513,514,515],"Tinengotinib (TT-00420)","Androgen Receptor Signaling Inhibitors (ARSIs)","TIP Study: Tinengotinib In Prostate Cancer","Prostate Cancer Clinical Trials Consortium, LLC (PCCTC)","24-103","2026-06-24",{"date":425,"type":38},{"date":519,"type":38},"2024-06-04",{"date":247,"type":20},{"name":33,"class":44},12,{"id":524,"slug":4,"hasResults":11,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":21,"phases":531,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":72},"100494339","NCT05716893","Study of Aerobic Training for People Receiving Treatment for Breast Cancer","Phase 2 Trial of Adaptive Versus Standard Dosing of Aerobic Training in Patients Receiving Treatment for Primary Breast Cancer","Inclusion Criteria:\n\n* Aged ≥18 years\n* Female\n* Diagnosed with primary breast cancer as defined by one of the following:\n\n  * Histological confirmation\n  * As per standard of care imaging\n* Scheduled to receive neoadjuvant\u002Fadjuvant systemic and\u002For locoregional therapy\n* Performing ≤90 minutes of moderate- and\u002For strenuous-intensity exercise per week, as evaluated by self-report\n* Willingness to comply with all study-related procedures\n* Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:\n\n  1. Achieving a plateau in oxygen consumption, concurrent with an increase in power output;\n  2. A respiratory exchange ratio ≥ 1.10;\n  3. Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \\[HRmax = 220-Age\\[years\\]);\n  4. Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.\n\nExclusion Criteria:\n\n* Enrollment onto any other interventional investigational study, except interventions determined by the PI not to confound study outcomes\n* Receiving treatment for any other diagnosis of invasive cancer\n* Distant metastatic malignancy of any kind\n* Mental impairment leading to inability to cooperate\n* Any of the following contraindications to cardiopulmonary exercise testing:\n\n  i. Acute myocardial infarction within 3-5 days of any planned study procedures; ii. Unstable angina; iii. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise; iv. Recurrent syncope; v. Active endocarditis; vi. Acute myocarditis or pericarditis; vii. Symptomatic severe aortic stenosis; viii. Uncontrolled heart failure; ix. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures; x. Thrombosis of lower extremities; xi. Suspected dissecting aneurysm; xii. Uncontrolled asthma; xiii. Pulmonary edema; xiv. Respiratory failure; xv. Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) xvi. Room air desaturation at rest ≤ 85%\n* Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation",{"count":530,"type":20},140,[107],"In this study, investigators will compare standard Aerobic Training\u002FAT with adaptive Aerobic Training\u002FAT. Standard AT will be a fixed (unchanging) amount of walking each week, while adaptive AT will adjust the level of exercise depending on participants' response to the exercise. Investigators will see how both study approaches (standard AT and adaptive AT) affect participants' CRF.",[135,534],"Breast Carcinoma",[536,537,538,539,540,33],"Breast cancer","Breast carcinoma","Primary breast cancer","Aerobic Training","22-364",{"date":324,"type":38},{"date":543,"type":38},"2023-01-30",{"date":545,"type":20},"2028-01-30",{"name":33,"class":44},{"id":548,"slug":4,"hasResults":11,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":21,"phases":555,"briefSummary":557,"conditions":558,"keywords":563,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":72},"100492351","NCT05691010","A Study of Short-Course Radiation Therapy With Chemotherapy in People With Endometrial Cancer","A Feasibility Study of Integrated Delivery of Hypofractionated Pelvic IMRT With Carboplatin and Paclitaxel in Stage III Copy-Number Low and Copy-Number High Subtypes of Endometrial Cancer","Inclusion Criteria:\n\n* Patients must have newly diagnosed endometrial carcinoma. The following histologic subtypes are eligible for inclusion: endometrioid, serous, clear cell, dedifferentiated\u002Fundifferentiated, mixed epithelial, adenocarcinoma not otherwise specified, and carcinosarcoma.\n* Surgery must have included a hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymph node surgical assessment (sentinel lymph node mapping and\u002For sampling). Para-aortic lymph node surgical assessment is optional.\n* Patients must have FIGO (2009) stage IIIA or IIIC1 disease (as determined by surgical staging).\n* Patients must consent to testing with MSK-IMPACT part A and are encouraged to consent to both parts A and C.\n* Age ≥ 18 years.\n* Patients must have an Karnofsky Performance Status (KPS) ≥ 70 (or ECOG 0 or 1).\n* Neurologic function: Neuropathy (sensory and motor) grade ≤ 1.\n* No residual gross disease after surgery.\n* No prior radiation therapy or chemotherapy for treatment of endometrial cancer.\n* No active infection requiring antibiotics, except for uncomplicated urinary tract infection.\n* Patients must have adequate organ function, defined by the following laboratory results prior to first study treatment:\n\n  * Absolute neutrophil count (ANC) ≥ 1500\u002FmcL\n  * Platelet count ≥ 100,000\u002FmcL\n  * AST\u002FALT ≤ 3X upper limit of normal (ULN)\n  * Total bilirubin ≤ 1.5X ULN. Patients with known Gilbert's disease and a total bilirubin ≤ 3X ULN may be enrolled.\n  * Creatinine ≤ 1.5X ULN\n* Entry into study is limited to no more than 12 weeks from the date of surgery.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patients of childbearing age will by definition have undergone hysterectomy and bilateral oophorectomy prior to study enrollment.\n* Participants must agree not to breastfeed during the study or for 150 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Patients whose endometrial cancers harbor known pathogenic POLE mutations\n* Patients whose endometrial cancers are mismatch repair deficient, as determined by immunohistochemical staining for MLH1, PMS2, MSH2, and MSH6 and\u002For MSI-H\n* Active inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. This includes but is not limited to: uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, and superior vena cava syndrome.\n* Patients unfit for pelvic radiation therapy due to the following:\n\n  * Has had radiation therapy encompassing \\>20% of the bone marrow within 2 weeks, or any radiation therapy within 1 week prior to day 1 of protocol therapy\n  * Patients with a history of pelvic radiation.\n  * Patients with a history or current diagnosis of a vesicovaginal, enterovaginal, or colovaginal fistula.\n  * Any hematological abnormality or disorder that would be a contraindication to radiation per the treating physician.",{"count":554,"type":20},28,[556],"EARLY_PHASE1","The purpose of this study is to find out whether short-course radiation therapy (1 week instead of the usual 5 weeks) with chemotherapy (carboplatin and paclitaxel) is practical (feasible), meaning that most participants are able to complete the treatment schedule.",[59,559,560,561,562],"Stage III Endometrial Cancer","Stage III Endometrial Carcinoma","Endometrial Carcinoma","Endometrial Carcinoma Stage III",[564,565,566,567,568,33,569],"endometrial cancer","endometrial cancer stage III","endometrial carcinoma stage III","stage III endometrial cancer","stage III endometrial carcinoma","22-405",{"date":425,"type":38},{"date":572,"type":38},"2023-01-10",{"date":574,"type":20},"2027-01-10",{"name":33,"class":44},{"id":577,"slug":4,"hasResults":11,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":21,"phases":584,"briefSummary":585,"conditions":586,"keywords":589,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":150},"100377838","NCT04199741","PET\u002FCT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56","Immuno-PET Imaging of Neuroendocrine Tumors Using 89Zr-DFO-SC16.56, a DLL3-targeting Monoclonal Antibody","Inclusion Criteria:\n\nSubject Inclusion Criteria for Adult population\n\n* Signed, informed consent\n* Age 18 or more years\n* Histologically confirmed, SCLC, (newly diagnosed or recurrent); small cell carcinoma of unknown or non-lung origin; or other types of neuroendocrine tumor OR Histologically confirmed prostate cancer, with suspected or confirmed NEPC based upon clinical assays obtained prior to the trial OR Histologically confirmed or suspected primary brain neoplasm OR Desmoplastic small round cell tumors, osteosarcoma, Ewing's sarcoma, rabdomyosarcoma, Wilms tumors, hepatoblastomas, rhabdoid tumors and neuroblastoma patients\n* At least one tumor lesion on CT2 or MRI ≥ 0.8 cm OR\n* Tumor detectable FDG PET, PSMA PET, DOTATATE PET, MIBG SPECT (or planar MIBG scan if SPECT unavailable) OR\n* MRI or bone scan that shows new osseous metastases. The scans should have been obtained in the last 12 weeks\n* ECOG performance status 0 to 2\n* Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential\n* Available archival tumor specimen suitable for DLL3 IHC or clinician already has plans to obtain tumor specimen as part of standard of care (unrelated to patient participation in 19-292) which will yield sufficient tumor specimen to allow for DLL3 IHC\n* For the prostate cancer patient cohort, as an alternative if archival tissue is not available, patients must be willing to undergo PET\u002FCT guided biopsy3 as described in section 9.3.\n\n  1. Patients with SCLC will be the primary study population, however patients with other types of neuroendocrine tumors may be included at the PI's discretion.\n  2. Criterion is intended to demonstrate presence of imageable disease. A low-dose CT (e.g. from a PET\u002FCT scan) may be used at PI's discretion.\n  3. While willingness to undergo the biopsy is required if archival tissue is not available, PET\u002FCT guided biopsy is not a mandatory study assessment. As described in section 9.3, the guided biopsy may be waived at the discretion of the principal investigator if the DLL3 PET\u002FCT reveals no sites of DLL3 tracer-avid tumor or if the principal investigator deems itis not in the best interest of the patient, according to best clinical judgement. The pediatric population would not be approached for an optional PET\u002FCT-guided biopsy\n\nSubject Inclusion Criteria for Pediatric population\n\n* Signed, informed consent\n* Age 4 or more years\n* High risk neuroblastoma patients\n* At least one tumor lesion on CT2 or MRI ≥ 0.8 cm OR Tumor detectable FDG PET, PSMA PET, DOTATATE PET, MIBG SPECT (or planar MIBG scan if SPECT unavailable) OR MRI or bone scan that shows new osseous metastases. The scans should have been obtained in the last 12 weeks\n* ECOG performance status 0 to 2\n* Performance Status: Subjects must have a Lansky (\\\u003C16 years) of at least 40\n* Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential\n\nExclusion Criteria:\n\nSubject Exclusion Criteria for the Adult population\n\n* History of anaphylactic reaction to humanized or human antibodies\n* Pregnant or breast feeding\n* Psychiatric illness that would interfere with compliance with the study procedures\n* Inability to undergo PET scan due to weight limit\n* Patients who require anesthesia or monitored sedation to tolerate PET scan procedure\n\nSubject Exclusion Criteria for the Pediatric population\n\n* History of anaphylactic reaction to humanized or human antibodies\n* Pregnant or breast feeding\n* Psychiatric illness that would interfere with compliance with the study procedures\n* Inability to undergo PET scan due to weight limit\n* Patients who require anesthesia or monitored sedation to tolerate PET scan procedure",{"count":583,"type":20},53,[23,107],"The purpose of this study is to look at how safe 89Zr-DFO-SC16.56 is, and how it is processed by the body in people with small cell lung cancer.",[587,588],"Small Cell Lung Cancer","Small Cell Lung Carcinoma",[590,588,591,592,33],"Small cell lung cancer","89Zr-DFO-SC16.56","19-292",{"date":425,"type":38},{"date":595,"type":38},"2019-12-11",{"date":597,"type":20},"2027-06-11",{"name":33,"class":44},{"id":600,"slug":4,"hasResults":11,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":21,"phases":607,"briefSummary":608,"conditions":609,"keywords":611,"overallStatus":618,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":72},"100624850","NCT07414992","A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer","Neoadjuvant STereotActic Body Radiotherapy and Cemiplimab With or Without Fianlimab for Cisplatin-Ineligible or Cisplatin-Declining Patients With Muscle-Invasive Bladder Cancer (NeoSTAR Bladder)","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of informed consent\n* ECOG 0-1\n* Histologically confirmed diagnosis of urothelial carcinoma.\n\n  ° Variant histology is acceptable if there is a predominant urothelial component. Any neuroendocrine \u002F small cell components are excluded (Investigators are encouraged to discuss with study team and PI)\n* Cystoscopically and radiographically confirmed cT2-4a cN0 cM0 disease per American Joint Committee on Cancer Staging Manual, 8th edition.\n\n  * Patients with cT4a disease invading into the prostatic stroma with no cystoscopic confirmation of muscle invasion are eligible.\n  * Clinically node-negative pelvis (cN0) on CT or MRI within 56 days: no pelvic lymph node ≥15 mm short-axis. Pelvic nodes 10-14 mm are permitted if not suspicious by GU radiology morphology; if deemed suspicious, biopsy or repeat imaging in 4-6 weeks must confirm cN0 prior to enrollment. PET may inform adjudication but is not required.\n* Patients declines cisplatin-based therapy or is ineligible for cisplatin-based therapy based on any of the following criteria:\n\n  * Estimated or calculated creatinine clearance ≥ 30ml\u002Fmin but \\\u003C 60 ml\u002Fmin\n  * Grade 2 or above audiometric hearing loss (per CTCAE v5.0)\n  * Grade 2 or above peripheral neuropathy (per CTCAE v5.0)\n* Availability of tumor specimen block or 20 unstained slides from diagnosis of muscle-invasive disease. Patients with fewer than 20 slides available may be enrolled after discussion with the Principal Investigator.\n* Medically appropriate candidate for radical cystectomy, as per MSK Attending Urologic Oncologist\n* Life expectancy ≥ 12 weeks at randomization\n* Required initial laboratory values:\n\n  * Absolute neutrophil count ≥ 1.0 x 10\\^9\u002FL\n  * Platelets ≥ 100 x 10\\^9\u002FL\n  * Bilirubin ≤1.5 times the upper limit of normal (x ULN)\n  * AST and ALT ≤ 3 x ULN\n  * Partial thromboplastin time (PTT)\u002Fprothrombin time (PT) ≤1.5 x ULN or international normalized ratio (INR) \\\u003C 1.7 x ULN for patients who are not receiving therapeutic anticoagulation. Patients receiving therapeutic anticoagulation should be on a stable dose.\n* For women of childbearing potential: agreement to remain abstinent (i.e., refrain from heterosexual intercourse) or use contraception, as defined below:\n\n  * Women must remain abstinent or use non-hormonal contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period plus 6 months after the last dose of cemiplimab with or without fianlimab.\n  * Examples of non-hormonal contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, and copper intrauterine devices\n  * A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a woman with a tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n* Male subjects must be willing to use contraception during the study and until 6 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Evidence of metastatic disease on standard staging CT and\u002For MR imaging\n* Evidence of nodal metastasis (cN+), defined as any pelvic node ≥15 mm short-axis on CT\u002FMRI or biopsy-proven nodal disease of any size.\n* Prior systemic chemotherapy or non-BCG immunotherapy (e.g., T cell co-stimulation or targeting of immune checkpoint pathways with anti-PD-1, anti-PD-L1, anti-LAG-3, anti-PD-L2, anti-CTLA-4, anti-CD137, IL-15 superagonist, or other medicines specifically targeting T cells other than prior IL-2 therapy) for the treatment of bladder cancer\n* Prior therapy with intravesical BCG within 6 weeks of treatment.\n* Prior pelvic RT\n* Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.\n* Patients using immunosuppressive doses (≥ 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement will not be eligible for the study. It is recommended that patients do not receive systemic corticosteroids such as hydrocortisone, prednisone, prednisolone (Solu-Medrol®) or dexamethasone (Decadron®) at any time throughout the study except in the case of a life-threatening emergency and\u002For to treat an immune-mediated adverse event.\n\n  °Immunosuppressive doses (≥ 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement must be discontinued within 14 days of initiating neoadjuvant SBRT.\n* Received a live vaccine within 30 days of planned start of study medication.\n\n  * Live or live attenuated vaccination with replicating potential. If a patient intends to receive a COVID-19 vaccine before the start of study drug, participation in the study should be delayed at least 1 week after any COVID-19 vaccination. During treatment period, it is recommended to delay COVID-19 vaccination until patients are receiving and tolerating a steady dose of study drug. A vaccine dose should not be less than 48 hours before or after study drug dosing.\n  * Live vaccines are also prohibited during neoadjuvant therapy and for 90 days after completing neoadjuvant therapy.\n* Has had an allogenic tissue\u002Fsolid organ transplant\n* Unstable angina.\n* New York Heart Association (NYHA) Grade II or greater congestive heart failure.\n* History of myocardial infarction within 6 months.\n* History of stroke within 6 months.\n* Evidence of bleeding diathesis or coagulopathy. Therapeutic anticoagulation is permitted, but patients must be on a stable dose.\n* Major surgical procedure within 28 days prior to the study other than transurethral resection of bladder tumor.\n* Serious, non-healing wound, ulcer, or bone fracture.\n* Other prior malignancy active within the previous 2 years except for local or organ-confined early-stage cancer that has been definitively treated with curative intent or does not require treatment, does not require ongoing treatment, has no evidence of active disease, and has a negligible risk of recurrence and is therefore unlikely to interfere with the endpoints of the study.\n* Uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.\n* Notes:\n\n  * Patients with known HIV who have controlled infection (undetectable viral and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.\n  * Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n  * Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n  * Patients with HIV or hepatitis must be reviewed by a qualified specialist (e.g., infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial.\n* Participants with a history of myocarditis.\n* Troponin T (TnT) or troponin I (TnI) \\> 2x institutional ULN at baseline.\n\n  * TnT or Tnl levels between \\> 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN.\n  * If TnT or Tnl levels are \\> 1 to 2x ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on the judgement in the patient's best interest.\n* Known hypersensitivity to the active substances or to any of the excipients.\n* WOCBP\\* must have a negative serum (beta-hCG) at screening.\n\n  * WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.\n\n    * A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the CTFG guidance.\n\nPregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.\n\n* Male study participants with WOCBP partners are required to use condoms during the study and until 6 months after the last dose of study treatment unless they are vasectomized or practice sexual abstinence.\n* Vasectomized partner or vasectomized study participant must have received medical assessment of the surgical success.\n* Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.\n\n  * WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and until 6 months after last treatment\n  * All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose\n  * Pregnant or breastfeeding women.\n  * Women of childbearing potential (WOCBP)\\* who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:\n* stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening;\n* intrauterine device; intrauterine hormone-releasing system;\n* bilateral tubal occlusion\u002Fligation;\n* vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and\u002For\n* sexual abstinence\n* Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.\n* Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.\n\n  * Active infection requiring therapy.\n  * Subjects who are compulsorily detained for treatment of a psychiatric illness.\n  * History or current evidence of significant (CTCAE grade ≥ 2) local or systemic infection (e.g, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.",{"count":606,"type":20},44,[107],"The researchers are doing this study to find out whether stereotactic body radiation therapy (SBRT) in combination with immunotherapy (cemiplimab with or without fianlimab) before cystectomy is an effective and safe treatment for people with muscle-invasive bladder cancer (MIBC).",[610],"Bladder Urothelial Carcinoma",[612,613,614,615,88,616,617],"Cemiplimab","Fianlimab","Bladder cancer","Muscle-invasive bladder cancer","Radiotherapy","25-328","NOT_YET_RECRUITING","2026-06-23",{"date":516,"type":38},{"date":622,"type":20},"2026-07",{"date":624,"type":20},"2028-03",{"name":33,"class":44},{"id":627,"slug":4,"hasResults":11,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":632,"targetDuration":4,"studyType":21,"phases":634,"briefSummary":635,"conditions":636,"keywords":639,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":642,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":354},"100580336","NCT06835972","A Study of Abemaciclib and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC)","A Phase 1b\u002F2 Study of Abemaciclib Plus Cabozantinib in Immune Checkpoint Blockade-pretreated Metastatic Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of informed consent\n* Patient must be able to provide informed consent, or a legal authorized representative (LAR) must be identified to provide consent in cases where the patient cannot\n* Signed and dated IRB-approved Informed Consent Form\n* Patient must have a histologically confirmed diagnosis of metastatic stage IV clear cell renal cell carcinoma or metastatic stage IV translocation-associated renal cell carcinoma.\n* Patient should have availability of archival tissue that enables definitive diagnosis of ccRCC or tRCC, per review at participating site, accompanied by an associated pathology report. Specimens can be collected by surgical resection or biopsy of the primary tumor or biopsy or resection of a metastatic lesion. NOTE: If archival tissue is unavailable, a patient can still enroll onto the study with documented confirmation from the study PI.\n* Patients must have at least one extra-skeletal, extracranial measurable lesion as defined by RECIST v1.1\n* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Patients must have received prior therapy with at least 2 approved systemic agents and a maximum of 3 prior lines of systemic therapy. Prior adjuvant therapy is permitted.\n* Patient must have progressed on 1 prior PD-1 or PD-L1 targeted treatment and prior VEGFR directed TKI therapy\n* Patients must have recovered to baseline or \\\u003C Grade 1 CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events (AEs) are clinically non-significant and\u002For stable on supportive therapy (See Appendix 2)\n* Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and registration.\n* The patient can swallow oral medications.\n* Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment:\n* ANC ≥ 1500 cells\u002FμL (without granulocyte colony stimulating factor support within 2 weeks prior to Cycle 1, Day 1)\n* WBC counts ≥ 2500\u002FμL and ≤ 15,000\u002FμL without G-CSF\n* Absolute Lymphocyte count \\> 0.5K\u002FmcL\n* Platelet count ≥100,000\u002FμL (without transfusion within 2 weeks prior to Cycle 1, Day 1)\n* Hemoglobin ≥9.0 g\u002FdL (without transfusion within 2 weeks prior to Cycle 1, Day 1)\n* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 X upper limit of normal (ULN). ALP ≤ 5 x ULN if patient has documented bone metastases.\n* Serum bilirubin ≤ 1.5 x ULN. Patients with known Gilbert disease who have serum bilirubin level ≤ 2 x ULN may be enrolled.\n* Serum albumin ≥ 2.8 g\u002Fdl\n* (PT)\u002FINR or partial thromboplastin time (PTT) test \\\u003C 1.3x the laboratory ULN\n* Estimated Glomerular Filtration Rate (eGFR) ≥ 30mL\u002Fmin using the CKD-EPI formula https:\u002F\u002Fwww.kidney.org\u002Fprofessionals\u002Fkdoqi\u002Fgfr\\_calculator.\n* Urine protein\u002Fcreatinine ratio (UPCR) ≤ 1.8 mg\u002Fmg\n* Women of childbearing potential must not be pregnant or lactating at screening.\n* Women of childbearing potential who are sexually active with a non-sterilized male partner must use two methods of effective contraception from screening and must agree to continue using such precautions for 4 months after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.\n* Sexually active participants must agree to use medically accepted methods of contraception (i.e. barrier methods including condoms, female condom, or diaphragm with spermicidal gel) during the study and for 4 months after the last dose of the study treatment. Male patients must agree not to donate sperm during the study treatment period and for 4 months after the last dose Female patients must agree not to donate eggs during the study period and for 4 months after the last dose.\n\nExclusion Criteria:\n\n* Prior treatment with abemaciclib or cabozantinib.\n* Receipt of any type of anti-cancer antibody, cytotoxic anticancer therapy, or any other investigational agents within 2 weeks of treatment start or 5 half-lives, whichever is shorter. For immune checkpoint inhibitors, patients must have discontinued treatment 28 days prior to trial enrollment.\n* Symptomatic brain metastasis or leptomeningeal disease requiring steroid use. Patients are eligible if they are neurologically stable for 4 weeks, have completed radiation therapy or surgery, and recovered from side effects. Patients must have discontinued steroid therapy for at least 2 weeks prior to first dose of study treatment.\n* Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or early stage cancers previously treated with curative intent.\n* Patients requiring moderate or strong CYP3A4 inducers or inhibitors (https:\u002F\u002Fdruginteractions.medicine.iu.edu\u002FMainTable.aspx).\n* Patients with a history of HIV infection who are not on a stable HAART regimen and\u002For are requiring antimicrobials for prevention of opportunistic infections and\u002For have CD4 count below 250 or a detectable HIV viral load\n* Patients with active hepatitis B or hepatitis C infection with detectable viral load by PCR\n* Active systemic bacterial infection (requiring systemic antibiotics at time of initiating study treatment) or fungal infection.\n* History of significant cardiovascular events or active cardiovascular disease; including myocardial infarction within the previous 6 months, unstable arrhythmias, unstable angina, prior sudden cardiac arrest, LVEF \\\u003C 50% by echocardiogram (ECHO).\n* Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 150 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment.\n* Significant arterial disease (e.g., stroke, transient ischemic attack, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Cycle 1, Day 1.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 470 ms per electrocardiogram (ECG) within 28 days before first dose of study treatment.\n\nNote: If a single ECG shows a QTcF with an absolute value \\> 470 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility\n\n* Concomitant anticoagulation with coumadin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:\n\n  * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n  * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.\n* Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).\n* Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n* Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 6 weeks before first dose of study treatment. Completeness of wound healing from any surgery must be ascertained. There must be a minimum of two weeks from completion of wound healing to start of study.\n* Evidence of tumor invading the gastrointestinal tract, active peptic ulcer disease, active inflammatory bowel disease, active diverticulitis, active cholecystitis, symptomatic\u002Factive cholangitis or appendicitis, acute pancreatitis, acute obstruction of pancreatic duct or common bile duct, or active gastric outlet obstruction.\n* Clinical signs or symptoms of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding.\n* Patients with a history of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to study enrollment.\n* The patient has tumor invading or encasing any major blood vessels, with exception of renal vessels ipsilateral to the primary renal tumor.\n* The patient has evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus) at time of study screening.\n* Patients with malabsorption syndrome.\n* Patients with a serious non-healing wound\u002Fulcer\u002Fbone fracture.\n* Patients with active COVID-19 unless the subject has clinically recovered from the disease at least 30 days prior to first dose of study treatment.\n* Previously identified allergy or hypersensitivity to components of the study treatment formulations.\n* Radiation therapy for bone metastasis within 2 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n* The patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).",{"count":633,"type":20},43,[23,107],"The researchers are doing this study to find out whether the combination of abemaciclib and cabozantinib is a safe and effective treatment for people with metastatic clear cell renal cell carcinoma (ccRCC) and translocation-associated renal cell cancer (tRCC). The researchers will test different doses of the study drugs to find the highest doses that cause few or mild side effects in participants.",[637,638],"Metastatic Renal Cell Carcinoma","Translocation Renal Cell Carcinoma",[640,641],"Abemaciclib","Cabozantinib",{"date":516,"type":38},{"date":644,"type":38},"2025-02-14",{"date":646,"type":20},"2027-02",{"name":33,"class":44},""]