[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"small-cell-carcinoma-of-the-bladder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:small-cell-carcinoma-of-the-bladder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100528496","phase-2-sacituzumab-govitecan-with-or-without-atezolizumab-immunotherapy-in-rare-genitourinary-tumors-smart-such-as-high-grade-neuroendocrine-carcinomas-adenocarcinoma-and-squamous-cell-bladderurinary-tract-cancer-renal-medullary-carcinoma-and-penile-c-100528496",false,"NCT06161532","Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as High Grade Neuroendocrine Carcinomas, Adenocarcinoma, and Squamous Cell Bladder\u002FUrinary Tract Cancer, Renal Medullary Carcinoma and Penile C...","A Phase II Study of Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as High Grade Neuroendocrine Carcinomas, Adenocarcinoma, and Squamous Cell Bladder\u002FUrinary Tract Cancer, Renal Medullary Carcinoma and Penile Cancer","* INCLUSION CRITERIA:\n* Participants must have histologically confirmed diagnosis of a locally advanced unresectable or metastatic non-prostate genitourinary (GU) tumor of the following histologies:\n\n  * HGNEC, including, but not limited to, small cell carcinoma and large cell neuroendocrine carcinoma of the bladder or urinary tract\n  * Squamous cell carcinoma of the bladder or urinary tract\n  * Primary adenocarcinoma of the bladder or urinary tract (urachal or non-urachal)\n  * Renal medullary carcinoma\n  * Squamous cell carcinoma of the penis\n\nNote: For the purposes of enrollment, the urinary tract is defined as the renal pelvis, ureter, bladder, and urethra.\n\n* Pre-study treatment tissue availability (sufficient tissue for approximately 25 unstained slides is mandatory for enrollment. If tissue is determined to be insufficient\u002Funsuitable, a fresh biopsy prior to study therapy will be required.\n* Locally advanced unresectable or metastatic disease. Participants who have received prior treatment must have evidence of progressive disease (PD; i.e., defined as new or progressive lesions evident on cross-sectional imaging).\n* Prior treatment as follows:\n\n  * Cohort A: Participants must have received prior ICIs (PD-1 or PD-L1) or be ineligible for treatment with ICIs.\n  * For Cohort B: Participants must be ICI naive but eligible to receive them.\n* Participants must have measurable disease, per RECIST 1.1.\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C= 1 (Karnofsky \\>= 70%.\n* Adequate organ and marrow function as defined below:\n\n  * Hemoglobin (Hgb) \\>= 9.0 g\u002FdL\n  * Absolute neutrophil count (ANC) \\>= 1,500\u002FmcL\n  * Platelets \\>= 100,000\u002FmcL\n  * Total bilirubin \\\u003C= 1.5 x upper limit of normal (ULN) (\\\u003C= 3 x ULN in participants with known\u002Fsuspected Gilbert s disease)\n  * AST\u002F ALT \\\u003C= 2.5 x ULN (or \\\u003C= 5 x ULN if considered to be related to liver metastases by the PI)\n  * Serum creatinine \\\u003C= 2 x ULN or creatinine clearance \\>= 30 ml\u002Fmin\u002F1.73 m\\^2 (glomerular filtration rate \\[GFR\\] may be used in place of CrCl. Creatinine clearance or eGFR should be calculated per institutional standard)\n  * Alkaline phosphatase \\\u003C= 2.5 x ULN (or \\\u003C= 5 x ULN if considered to be related to liver or bone metastases by the PI)\n  * Serum albumin \\>= 25g\u002FL\n  * For participants not receiving therapeutic anticoagulation: international normalized ratio (INR) or activated partial thromboplastin time (aPTT) \\\u003C= 1.5 x ULN\n  * For participants receiving therapeutic anticoagulation: stable anticoagulant regimen\n* Participants may have received any number of prior anti-cancer treatments or be treatment na(SqrRoot) ve (except for participants with HGNEC of the bladder\u002Furinary tract cancer, whom must have received a platinum-based combination regimen either as neoadjuvant, adjuvant or first-line treatment in the locally advanced\u002Fmetastatic setting).\n* Treated central nervous system (CNS) lesions, provided that all of the following criteria are met:\n\n  * Measurable disease, per RECIST v1.1, must be present outside the CNS.\n  * The participant has no history of intracranial hemorrhage or spinal cord hemorrhage.\n  * The participant has not undergone stereotactic radiotherapy within 1 week prior to initiation of study treatment, whole-brain radiotherapy (WBXRT) within 2 weeks prior to initiation of study treatment, or neurosurgical resection within 4 weeks prior to initiation of study treatment.\n  * The participant has no ongoing requirement for corticosteroids as therapy for CNS disease.\n  * The participant may be receiving anti-convulsant therapy if appropriate and the dose is considered stable.\n\nPrior treatment as follows:\n\n* Prior radionuclide treatment must have a washout period of at least 6 weeks prior to the first dose of study treatment.\n* Prior treatment with chemotherapy must have a washout period of 2 weeks prior to the first dose of study treatment.\n* Prior treatment with non-CNS-directed radiotherapy must have a washout period of 2 weeks prior to the first dose of study treatment (except palliative bone-directed radiotherapy which does not require any washout).\n* Prior treatment with a small molecule kinase inhibitor must have a washout period of at least 2 weeks or five half-lives of the compound or active metabolites, prior to the first dose of study treatment.\n* Prior treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) must have a washout period of at least 4 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of study treatment.\n* Major surgical procedure, other than for diagnosis, must not occur within 4 weeks prior to the first dose of study treatment.\n* Prior treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents) must have a washout period of at least 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  * Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.\n  * Participants who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n* FDA-approved hormonal therapy for the treatment or prevention of other malignancies (e.g., breast cancer, prostate cancer) are allowed to be continued where in the opinion of the treating investigator stopping such therapies may increase the risk of disease progression. Potential drug-drug interactions with the hormonal agent will be assessed by the treating investigator prior to enrollment and hormonal agents that inhibit or induce UGT1A1 will be excluded while on trial.\n* Human immunodeficiency virus (HIV)-infected participants are eligible if on stable dose of highly active antiretroviral therapy (HAART), a CD4 count \\>= 200 cells\u002FmicroL, and an undetectable viral load.\n* Hepatitis B virus (HBV) positive participants are eligible if they have been treated or are on an appropriate course of antivirals at study entry and with planned monitoring and management according to appropriate guidance. For previously treated patients or those with prior infection that has been cleared, prophylaxis is permitted, and hepatology consultation recommended.\n* Participants with a history of hepatitis C virus (HCV) infection (i.e., positive HCV antibody test) must have been treated and cured (negative HCV RNA test at screening). Participants with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.\n* Individuals of child-bearing potential (IOCBP) and individuals able to father a child must agree to use an effective method of contraception as follows:\n\n  * IOCBP must agree to use one (1) highly effective methods of contraception (e.g., intrauterine device \\[IUD\\], hormonal, surgical sterilization) prior to study entry, for the duration of study participation, and for up to 6 months after discontinuation of the study drug(s). Participants must refrain from donating eggs during this same period.\n  * Individuals able to father children must agree to use an effective method of contraception (barrier, surgical sterilization) for the duration of the study treatment and up to 6 months after the last dose of the study drug(s) and must refrain from donating sperm during this same period.\n* Nursing participants must discontinue nursing and\u002For not begin nursing until 1 month after the last dose of study drug(s).\n* Ability of participants to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of severe hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to SG, SN-38, irinotecan, or atezolizumab, or hypersensitivity to Chinese hamster ovary cell products.\n* Symptomatic or untreated brain\u002FCNS metastases.\n* Positive serum or urine Beta-human chorionic gonadotropin (Beta-hCG) test at screening.\n* Participants unwilling to accept blood products as medically indicated.\n* For Cohort B: Active or history of autoimmune disease or immune deficiency that might recur, which might affect vital organ function or require immune suppressive treatment including systemic corticosteroids, when receiving atezolizumab. These conditions include myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:\n\n  * Participants with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  * Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n    * Rash must cover \\\u003C 10% of body surface area.\n    * Disease is well controlled at baseline and requires only low-potency topical corticosteroids.\n    * There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Anticipation of need for a major surgical procedure during the study.\n* Prior allogeneic stem cell or solid organ transplantation.\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during SG or atezolizumab treatment or within 5 months after the final dose of SG or atezolizumab. Note: Seasonal flu vaccines that do not contain a live virus and locally authorized\u002Fapproved COVID-19 vaccines are permitted.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) with the exception of participants with indwelling catheters (e.g., PleurX(R)) who are allowed.\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN).\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, cerebrovascular accident, unstable arrhythmia, or unstable angina) within 3 months prior to initiation of study treatment.\n* Prior treatment with immune checkpoint blockade therapies, including anti-PD-1, and anti-PD-L1 therapeutic antibodies (for Arm 2 only).\n* Participants with prior malignancy within the previous 2 years except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or low risk Gleason 6 prostate cancer, among others. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for the study.\n* History of leptomeningeal disease\n* Active tuberculosis\n* Participants with severe uncontrolled intercurrent illness that would limit compliance with study requirements, evaluated by history, physical exam, and chemistry panel.","ALL","18 Years","120 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background:\n\nRare tumors of the genitourinary (GU) tract can appear in the kidney, bladder, ureters, and penis. Rare tumors are difficult to study because there are not enough people to conduct large trials for new treatments. Two drugs-sacituzumab govitecan (SG) and atezolizumab-are each approved to treat other cancers. Researchers want to find out if the two drugs used together can help people with GU.\n\nObjective:\n\nTo test SG, either alone or combined with atezolizumab, in people with rare GU tumors.\n\nEligibility:\n\nAdults aged 18 years and older with rare GU tumors. These may include high grade neuroendocrine carcinomas; squamous cell carcinoma of the bladder; primary adenocarcinoma of the bladder; renal medullary carcinoma; or squamous cell carcinoma of the penis.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. They will have tests of heart function. They will have imaging scans. They may need a biopsy: A small needle will be used to remove a sample of tissue from the tumor.\n\nBoth SG and atezolizumab are given through a tube attached to a needle inserted into a vein in the arm.\n\nAll participants will receive SG on days 1 and 8 of each 21-day treatment cycle. Some participants will also receive atezolizumab on day 1 of each cycle.\n\nBlood and urine tests, imaging scans, and other exams will be repeated during study visits.\n\nTreatment may continue for up to 5 years.\n\nFollow-up visits will continue for 5 more years.",[27,28,29,30,31,32,33,34],"Small Cell Carcinoma of the Bladder","Small Cell Carcinoma of the Urinary Tract","Squamous Cell Carcinoma of the Bladder","Squamous Cell Carcinoma of the Urinary Tract","Primary Adenocarcinoma of the Bladder","Primary Adenocarcinoma of the Urinary Tract","Renal Medullary Carcinoma","Squamous Cell Carcinoma of the Penis",[36,37,38,39,40],"Urothelial carcinoma","Trophoblastic cell surface antigen 2","Programmed death-ligand 1","SN-38","Immunotherapy","RECRUITING","2026-07-01",{"date":44,"type":45},"2026-07-02","ACTUAL",{"date":47,"type":45},"2024-08-01",{"date":49,"type":21},"2028-11-01",{"name":51,"class":52},"National Cancer Institute (NCI)","NIH",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":53},"100533611","phase-2-lurbinectedin-with-or-without-avelumab-in-small-cell-carcinoma-of-the-bladder-laser-100533611","NCT06228066","Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)","A Phase II Study of Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)","* INCLUSION CRITERIA:\n* Histologically or cytologically confirmed metastatic small cell carcinoma of the bladder (SCCB) or other high grade neuroendocrine tumors (HGNETs) of the urinary tract (which includes renal pelvis, ureter, and urethra, and excludes neuroendocrine tumors of the prostate). Mixed histologies, with any component including SCCB or HGNETs, are eligible for inclusion.\n* Prior treatment as follows:\n\n  * For Cohort 1: Participants must have received prior ICIs (PD-1 or PD-L1) or be ineligible for treatment with ICIs.\n  * For Cohort 2: Participants must be ICI naive but eligible to receive them.\n* Participants must have metastatic disease defined as new or progressive lesions.\n* Participants must have at least one measurable site of disease, per RECIST 1.1.\n* Participants must have received, be ineligible, or refused prior platinum\u002Fetoposide chemotherapy for SCCB or other HGNET of the urinary tract. Platinum ineligibility is defined as a CrCl \\\u003C30, or two or more of the following: CrCl \\\u003C50-60, ECOG \\>=2, hearing loss \\>= grade 2, peripheral neuropathy \\>= grade 2, New York Heart Association (NYHA) heart failure class \\>= class III.\n* Age \\>=18 years.\n* Eastern Cooperative Oncology Group \\[ECOG\\] performance status (PS) \\\u003C=2 (Karnofsky \\>=60%).\n* Adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>=1,500\u002Fmicroliter\n  * Platelets \\>=100,000\u002F microliter\n  * Hemoglobin (Hgb) \\> 9g\u002FdL (erythrocyte transfusions are allowed to achieve acceptable Hgb)\n  * Total bilirubin within normal limits with the following exceptions:\n\n    * Participants with tumor involving the liver may have mild to moderate hepatic impairment with total bilirubin \\\u003C= 1.5 x upper limit of normal (ULN)\n    * Participants with known Gilbert disease who have serum bilirubin level \\\u003C= 1.5 x ULN\n  * Aspartate aminotransferase (AST)\u002F alanine aminotransferase (ALT) \\\u003C=1.5 x institutional ULN\n\n    ---Participants with tumor involving the liver with AST and ALT \\\u003C= 5.0 x ULN and bilirubin \\\u003C= 1.5 x ULN may be eligible.\n  * Creatinine clearance (CrCl) \\>= 30 mL\u002Fmin\u002F1.73 m\\^2 (glomerular filtration rate \\[GFR\\] may be used in place of CrCl. Creatinine clearance or eGFR should be calculated per institutional standard)\n  * Creatine phosphokinase (CPK) \\\u003C= 2.5 x ULN\n* Participants with previously treated brain metastases or central nervous system (CNS) metastases are eligible if they have recovered from any acute effects of radiotherapy and not requiring steroids, and any whole brain radiation therapy or any stereotactic radiosurgery was completed at least 2 weeks prior to initiation of therapy.\n* Human immunodeficiency virus (HIV) positive participants are eligible if on stable dose of highly active antiretroviral therapy (HAART), CD4 counts are \\> 350 cells\u002Fmm\\^3 and viral load is undetectable.\n* Hepatitis B virus (HBV) positive participants are eligible if they have been treated or are on an appropriate course of antivirals at study entry and with planned monitoring and management according to appropriate guidance including prophylaxis.\n* Hepatitis C virus (HCV) positive participants are eligible if:\n\n  * they are on active HCV therapy at study entry or are on an appropriate course of antivirals without documented clinically significant impaired liver function test or hematologic abnormalities and with planned monitoring and management according to appropriate labeling, or if they are post-treatment for HCV; or\n  * they have a negative polymerase chain reaction (PCR).\n* Systemic corticosteroid therapy (defined as \\>= the equivalent of prednisone 10 mg\u002Fday) or other immunosuppressive agents such as azathioprine or cyclosporin must be discontinued at least 1 week prior to treatment initiation for recent short course use (\\\u003C=14 days) or discontinued at least 4 weeks prior to treatment initiation for long term use (\\>14 days).\n* Contraception requirements as follows:\n\nIndividuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (e.g., intrauterine device \\[IUD\\], hormonal, surgical sterilization, abstinence) prior to study entry, for the duration of study participation, and for up to six (6) months after discontinuation of the study drug(s).\n\n* Individuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to six (6) months after the last dose of the study drug(s). We also will recommend individuals able to father a child with IOCBP partners to ask the partners to be on an effective birth control (hormonal, intrauterine device (IUD), surgical sterilization). Individuals able to father a child must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through six (6) weeks after the last dose of the study drug(s).\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Prior investigational drug, chemotherapy, immunotherapy or any prior radiotherapy (except for palliative bone directed therapy) within the past 14 days prior to the first drug administration. Additionally, FDA-approved hormonal therapy for the treatment or prevention of other malignancies (e.g., breast cancer, prostate cancer) may be continued where in the opinion of the investigator stopping such therapies may increase the risk of disease progression. Potential drug-drug interactions with the hormonal agent will be assessed by the enrolling investigator prior to enrollment.\n* Participants previously treated with lurbinectedin.\n* History of anaphylactic allergic reactions attributed to compounds of similar chemical or biologic composition to lurbinectedin or avelumab\n* Symptomatic or untreated CNS metastases\n* For Cohort 2: Active autoimmune disease that might deteriorate when receiving avelumab with the exception of:\n\n  * Diabetes type I, eczema, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment\n  * Requirement of hormone replacement with corticosteroids if the steroids are administered only for the purpose of hormonal replacement and at doses \\\u003C= 10mg of prednisone or equivalent per day\n  * Requirement of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation)\n  * Physiologic doses of corticosteroids (\\\u003C= the equivalent of prednisone 10 mg\u002Fday). The use of corticosteroids as premedication for contrast-enhanced studies is allowed prior to treatment initiation and on study.\n* Prior organ transplantation including allogenic stem cell transplantation.\n* Participants who have received or will receive a live vaccine within 30 days prior to the first administration of study intervention. Seasonal flu vaccines that do not contain a live virus and locally authorized\u002Fapproved COVID-19 vaccines are permitted.\n* Pregnant people as evaluated by a positive serum or urine beta-human chorionic gonadotropin (beta-hCG) test\n* Severe uncontrolled intercurrent illness that would limit compliance with study requirements, evaluated by history, physical exam, and chemistry panel.",{"count":62,"type":21},45,[24],"Background:\n\nSmall cell carcinoma of the bladder (SCCB) and other high-grade neuroendocrine tumors (HGNET) of the urinary tract are rare but aggressive cancers. Average survival for people diagnosed with SCCB or HGNET is about 1 year. Lurbinectedin and avelumab are drugs that are approved to treat other cancers. Researchers want to see if these drugs can help people with SCCB or HGNET.\n\nObjective:\n\nTo test lurbinectedin with or without avelumab in people with SCCB or HGNET.\n\nEligibility:\n\nAdults aged 18 years and older with SCBB or HGNET that returned and spread after treatment.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam. They will have blood tests and imaging scans. They may need to have a new biopsy: A small needle will be used to collect a tissue sample from the tumor.\n\nBoth study drugs are given through a tube attached to a needle inserted into a vein. If participants have already received a drug like avelumab they will receive only lurbinectedin. If patients have not been previously treated with a drug like avelumab they will receive both lurbinectedin and avelumab. All participants will receive their treatment once every 3 weeks for up to 10 years. They will also receive other drugs to relieve adverse effects.\n\nBiopsies, blood tests, and imaging scans will be repeated during some study visits. Participants may also have urine tests and tests of their heart function.\n\nParticipants may remain in the study as long as the treatment is helping them. If they stop treatment, they will have safety visits 14, 30, and 90 days after their last dose. Additional follow-up visits will continue 5 to 10 years.",[27,66],"High Grade Neuroendocrine Tumors of the Urinary Tract",[68,69,70,71,40,72],"High grade neuroendocrine tumors","small cell neuroendocrine carcinoma","large cell neuroendocrine carcinoma","transcription factor inhibitor","programmed cell death 1 ligand 1","2026-06-04",{"date":75,"type":45},"2026-06-05",{"date":77,"type":45},"2024-06-13",{"date":79,"type":21},"2028-09-01",{"name":51,"class":52}]