[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoma-transitional-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoma-transitional-cell":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,63,75,119],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053764","phase-3-a-study-of-vepugratinib-ly3866288-in-participants-with-cancer-in-the-urinary-tract-100053764",false,"NCT07218380","A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract","FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab in Adults With Untreated Locally Advanced or Metastatic Urothelial Carcinoma With an FGFR3 Genetic Alteration","FORAGER-2","Inclusion Criteria:\n\n* Have histologically confirmed, unresectable locally advanced or metastatic urothelial cancer (mUC). Individuals with mixed histology other than small cell or neuroendocrine carcinoma are eligible if a urothelial component is present.\n* Have a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration determined via molecular testing from a tumor or blood sample obtained at or any time after diagnosis of advanced or metastatic urothelial cancer.\n* Have measurable disease by investigator assessment defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Have adequate laboratory parameters\n\nExclusion Criteria:\n\n* Have received prior systemic therapy for locally advanced or metastatic urothelial cancer (mUC).\n* Have any unresolved toxicities greater than Grade 1 Common Terminology Criteria for Adverse Events (\\[CTCAE\\] version 5.0) from prior neoadjuvant or adjuvant systemic therapy.\n* Have ongoing sensory or motor neuropathy of Grade 2 or higher\n* Have untreated or uncontrolled central nervous system (CNS) involvement or any history of leptomeningeal disease.\n* Current evidence corneal keratopathy or retinal disorder confirmed by ocular examination at screening.","ALL","18 Years",{"count":20,"type":21},450,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to test a new medicine, vepugratinib, in comparison with placebo, to see if it is safe and can help people with a bladder cancer that is advanced or has spread.\n\nVepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab.\n\nStudy participation could last up to approximately 6 years.",[27,28,29],"Carcinoma, Transitional Cell","Urinary Bladder Neoplasms","Neoplasm Metastasis",[31,32,33],"FGFR3","Advanced Urothelial Carcinoma","Metastatic Urothelial Carcinoma","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2025-12-12",{"date":42,"type":21},"2033-05",{"name":44,"class":45},"Eli Lilly and Company","INDUSTRY",286,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":62,"locationsCount":4},"100644897","expanded-access-for-vepugratinib-ly3866288-in-participants-with-fibroblast-growth-factor-receptor-3-fgfr3-altered-solid-tumors-100644897","NCT07675057","Expanded Access for Vepugratinib (LY3866288) in Participants With Fibroblast Growth Factor Receptor 3 (FGFR3) Altered Solid Tumors","Expanded Access for Vepugratinib in Participants With Fibroblast Growth Factor Receptor 3 (FGFR3) Altered Solid Tumors","Inclusion Criteria:\n\n* Have metastatic urothelial carcinoma (UC) or other solid tumor with a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration.\n* Have exhausted other approved treatments, including erdafitinib for UC.\n* Are not eligible for an ongoing vepugratinib clinical trial\n\nExclusion Criteria:\n\n* Currently enrolled in an ongoing clinical study of vepugratinib\n* Have a known severe (greater than or equal to (≥) Grade 3) hypersensitivity to any component or excipient of vepugratinib.\n* Current evidence of corneal keratopathy or retinal disorder confirmed by ocular examination. Exception: Individuals with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk.\n* Significant cardiovascular disease:\n* Are pregnant, breastfeeding, or intent to become pregnant during the study or within 6 months of the last dose of study intervention.","EXPANDED_ACCESS","The treating physician\u002Finvestigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.",[28,29,27],[33],"AVAILABLE","2026-06-23",{"date":61,"type":38},"2026-06-30",{"name":44,"class":45},{"id":64,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":25,"conditions":67,"keywords":68,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":73,"locationsCount":74},"100609730",{"count":20,"type":21},[24],[27,28,29],[31,32,33],"2026-06-19",{"date":59,"type":38},{"date":40,"type":38},{"date":42,"type":21},{"name":44,"class":45},284,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":118},"100607533","phase-2-toripalimab--sequential-intravesical-gemcitabine-mitomycin-c-for-bcg-unresponsive-intolerant-high-risk-nmibc-open-label-randomized-phase-2-study-100607533","NCT07189793","Toripalimab ± Sequential Intravesical Gemcitabine-Mitomycin C for BCG-Unresponsive\u002F-Intolerant High-Risk NMIBC: Open-Label Randomized Phase 2 Study","Toripalimab With Sequential Intravesical Gemcitabine-Mitomycin C Versus Toripalimab Alone for the Treatment of BCG-Unresponsive\u002F-Intolerant High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized, Multicenter, Phase 2 Study","OHAI-NMIBC-01","Inclusion Criteria:\n\n1. Age ≥18 years; sex: all; signed written informed consent by the participant or legally authorised representative.\n2. Histologically confirmed high-risk non-muscle-invasive bladder cancer (HR-NMIBC), defined as any T1, high-grade Ta, and\u002For carcinoma in situ (CIS).\n3. BCG-intolerant (unable to continue BCG because of severe adverse reactions) or meeting at least one definition of BCG treatment failure:\n\n   1. Persistent or recurrent CIS within 12 months after completion of adequate BCG (with or without concomitant NMIBC);\n   2. Recurrent high-grade Ta\u002FT1 within 6 months after completion of adequate BCG;\n   3. High-grade T1 at the first evaluation after BCG induction (\\~3 months);\n   4. Ta high-grade and\u002For CIS present or recurrent at \\~3 months after receiving ≥5 BCG instillations.\n\n   Adequate BCG, for the purposes of this protocol, is defined as receipt of at least 5 of 6 induction instillations (maintenance not required).\n4. ECOG performance status 0-2.\n5. Adequate organ function per protocol laboratory criteria.\n6. No intravesical chemotherapy or immunotherapy between the most recent cystoscopy\u002FTURBT and study start; a single immediate postoperative intravesical chemotherapy at the time of the most recent cystoscopy\u002FTURBT is allowed during screening per local practice.\n7. Willing and able to comply with study procedures.\n\nExclusion Criteria:\n\n1. Muscle-invasive bladder cancer (T2-T4).\n2. Low-grade (LG) recurrence during or after BCG therapy.\n3. Concomitant upper tract urothelial carcinoma, or lymph-node\u002Fdistant metastasis.\n4. Indwelling ureteral stent or known vesicoureteral reflux.\n5. Contraindications to intravesical instillation, including within 2 weeks after TURBT, bladder perforation, symptomatic urinary tract infection, or gross haematuria.\n6. Known hypersensitivity or contraindication to gemcitabine, mitomycin C, or toripalimab.\n7. Systemic chemotherapy, small-molecule targeted therapy, or radiotherapy within 2 weeks before first study treatment.\n8. Prior immune checkpoint inhibitor therapy.\n9. Pregnant, planning pregnancy, or breastfeeding women.\n10. Ongoing acute or chronic systemic infection, or history of active tuberculosis.\n11. Other malignancy requiring active treatment.\n12. Any condition that, in the investigator's judgment, makes participation not in the patient's best interest or could confound study results.\n\nStudy Population Adults with BCG-unresponsive or BCG-intolerant HR-NMIBC treated at participating centres in China.",{"count":84,"type":21},106,[86],"PHASE2","This open-label, randomised, multicentre, phase 2 study (OHAI-NMIBC-01) compares toripalimab plus sequential intravesical gemcitabine followed by mitomycin C (GEM→MMC) with toripalimab alone in adults with BCG-unresponsive or BCG-intolerant high-risk non-muscle-invasive bladder cancer (HR-NMIBC). Two prespecified cohorts are analysed: (1) CIS cohort (CIS with\u002Fwithout Ta\u002FT1) and (2) non-CIS cohort (high-risk Ta\u002FT1 without CIS). In the combination arm, intravesical GEM→MMC is given weekly for 6 weeks (induction) and, for patients without recurrence at the first tumour assessment (\\~month 3), monthly maintenance continues up to 24 months or until progression\u002Funacceptable toxicity; toripalimab IV every 3 weeks starts during the first intravesical cycle and continues up to 24 months or until progression\u002Funacceptable toxicity. The monotherapy arm receives toripalimab IV every 3 weeks up to 24 months or until progression\u002Funacceptable toxicity. Cystoscopy and urine cytology are performed every 3 months; imaging every 24 weeks. Primary endpoints are 3-month complete response (CR) rate in the CIS cohort and median recurrence-free survival (RFS) in the non-CIS cohort. Secondary endpoints include landmark CR, PFS and OS, RFS\u002FHG-RFS landmarks in the non-CIS cohort, and safety (CTCAE v5.0). Exploratory analyses will assess outcomes by protocol-defined PD-L1 status. Approximately 106 participants will be enrolled at multiple sites in China.",[28,27,89,90],"Carcinoma in Situ of Bladder","Non-Muscle-Invasive Bladder Cancer",[92,93,94,95,96,97,98,99,100,101,102,103,104,105,106],"NMIBC","High-Risk NMIBC","BCG-Unresponsive","BCG-Intolerant","BCG Failure","Carcinoma in Situ (CIS)","Intravesical Therapy","Ta","T1","Gemcitabine","Mitomycin C","GEM-MMC","Toripalimab","PD-1 Inhibitor","Bladder-Sparing","NOT_YET_RECRUITING","2025-09-17",{"date":110,"type":38},"2025-09-24",{"date":112,"type":21},"2025-10",{"date":114,"type":21},"2028-10",{"name":116,"class":117},"First Affiliated Hospital of Wenzhou Medical University","OTHER",1,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":127,"targetDuration":129,"studyType":130,"phases":4,"briefSummary":131,"conditions":132,"keywords":140,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":175},"100506479","utract-jelmyto-registry-a-registry-of-patients-with-upper-tract-urothelial-cancer-utuc-treated-with-jelmyto-100506479","NCT05874921","uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto","uTRACT Jelmyto Registry: A Multicenter, Prospective and Retrospective Registry to Evaluate Real World Experience and Outcomes of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto","uTRACT","Inclusion Criteria:\n\n* Adults \\>18 years old and capable of giving informed consent.\n* Diagnosis of UTUC.\n* Receipt of at least 1 dose of JELMYTO after FDA approval (15 Apr 2020).\n\nExclusion Criteria:\n\n* Incapable of giving informed consent (e.g., incarcerated individuals, individuals with dementia).\n* Receipt of 1 or more doses of JELMYTO (also referred to as UGN-101 or Mitogel in clinical development) before FDA approval (on or before 15 Apr 2020).\n* Pregnancy or lactation.\n* Unable to comply with protocol requirements (for prospective data capture).\n* Any medical or mental condition(s) that makes participation in the Registry inadvisable in the opinion of the Investigator (for prospective data capture).",{"count":128,"type":21},400,"3 Years","OBSERVATIONAL","The purpose of this registry is to evaluate real world experience and outcomes of patients with Upper Tract Urothelial Cancer (UTUC) treated with Jelmyto in the United States.",[133,134,135,136,137,138,27,139],"Urothelial Carcinoma","Urothelial Carcinoma Recurrent","Urothelial Carcinoma Ureter","Urothelial Carcinoma Ureter Recurrent","Urothelial Cancer of Renal Pelvis","Urothelial Carcinoma of the Renal Pelvis and Ureter","Transitional Cell Carcinoma of Renal Pelvis",[141,142,143,102,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165],"Upper Tract Urothelial Cancer","UTUC","UGN-101","TCC","Ureteral","Upper Tract","Carcinoma","Kidney","Renal","Gel","Local","Prolonged Release","Slow Release","Kidney Sparing","Recurrence","Neoplasms by Histologic Type","Neoplasms","Urologic Neoplasms","Urogenital Neoplasms","Neoplasms by Site","Antibiotics, Antineoplastic","Antineoplastic Agents","Alkylating Agents","Nucleic Acid Synthesis Inhibitors","Enzyme Inhibitors","2025-02-25",{"date":168,"type":38},"2025-02-28",{"date":170,"type":38},"2023-11-17",{"date":172,"type":21},"2028-01",{"name":174,"class":45},"UroGen Pharma Ltd.",22]