[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"renal-medullary-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:renal-medullary-carcinoma":33},{"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","2026-08-12",{"date":44,"type":45},"2026-08-13","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":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":53},"100539340","phase-2-pembrolizumab-plus-enfortumab-vedotin-in-collecting-duct-and-renal-medullary-carcinoma-100539340","NCT06302569","Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma","Activity of Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma","REPRINT","Inclusion Criteria:\n\n* Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of metastatic or advanced Collecting Duct Carcinoma or Medullary Renal Cell Carcinoma will be enrolled in this study.\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Have confirmed histology diagnosis of Collecting Duct Carcinoma or Medullary Renal Cell Carcinoma by central pathology review.\n* Archival tumor tissue sample or newly obtained \\[core, incisional or excisional\\] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n* Have adequate organ function as defined in the following table (Table 4). Specimens must be collected within 10 days prior to the start of study intervention.\n* Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.\n\nNote: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.\n\nHepatitis B screening tests are not required unless:\n\n1. Known history of HBV infection\n2. As mandated by local health authority\n\n   * Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\nNote: Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n\nHepatitis C screening tests are not required unless:\n\na) Known history of HCV infection b) As mandated by local health authority\n\n* HIV-infected participants must have well-controlled HIV on ART, defined as:\n\n  1. Participants on ART must have a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n  2. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening\n  3. It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n  4. 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  5. The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors\u002Finducers\u002Fsubstrates (https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers)\n\n     Exclusion Criteria:\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n* Has received prior systemic anti-cancer therapy, including investigational agents, within 2 weeks prior to treatment allocation.\n* Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS diseases permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n* Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":63,"type":21},23,[24],"This is a single-arm, monocentric, phase II trial, enrolling patients with histological diagnosis of collecting duct carcinoma and renal medullary carcinoma with locally advanced or metastatic disease who will be treated with Pembrolizumab plus Enfortumab Vedotin.\n\nApproximately, 23 patients will be enrolled. At screening, pre-existing archival primary and metastatic FFPE tumor specimen will be collected and submitted for central pathology review and translational analysis. All participants will undergo baseline screening imaging for clinical staging. Patients will be treated with Pembrolizumab q21 plus Enfortumab Vedotin 1,8q21 for 3 cycles (3 infusion of Pembrolizumab and 6 infusion of Enfortumab Vedotin) then radiological imaging will be repeated and patients with SD, PR or CR will continue pembrolizumab until disease progression, unacceptable toxicities or completion of treatment (17 cycles). Patients with progressive disease after 3 cycles of study intervention will be treated as per clinical practice.\n\nPatients who will experience progressive disease during pembrolizumab monotherapy treatment could restart Enfortumab Vedotin.\n\nThe study will also involve collection of a blood sample taken at the commencement of treatment, at the first cycle, after cycle 3 and at the end of treatment or progression of disease, to be used for research purposes.",[67,68,33],"Bellini Carcinoma","Collecting Duct Carcinoma",[70,71,72,68,33],"Pembrolizumab","Enfortumab Vedotin","Non-clear cell renal cell carcinoma","2025-09-02",{"date":75,"type":45},"2025-09-09",{"date":77,"type":45},"2025-05-30",{"date":79,"type":21},"2029-05",{"name":81,"class":82},"Giuseppe Procopio","OTHER"]