5 active not recruiting, 4 completed, 4 recruiting. 13 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Active not recruiting 5, Completed 4, Recruiting 4 |
| Phase 2 | 2 | Recruiting 2 |
Follow Urothelial Cancer: new trials by email Literature Review of Urothelial Cancer trials Research Report on Urothelial Cancer
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| BL-M07D1 (Trastuzumab Brengitecan T-bren) vs Standard of Care Platinum-based Chemotherapy (PBC) for HER2-expressing Metastatic Urothelial Cancer After Progression on Anti-PD-(L)1-based Therapy T-Bren, Dose level 1, T-bren, Dose level 2, Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin) - Urothelial Cancer, Metastatic Urothelial Cancer | Phase 3 | Recruiting | SystImmune Inc. | 520 | 2026-09-01 | 2026-10-13 |
| Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309) Enfortumab vedotin, Conventional Radiotherapy, Hypofractionated Radiotherapy - Urothelial Cancer, Urinary Bladder Neoplasms | Phase 3 | Recruiting | Astellas Pharma Global Development, Inc. | 390 | 2026-05-11 | 2026-10-28 |
| Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy Iza-bren, Cisplatin, Gemcitabine - Urothelial Cancer | Phase 2 / Phase 3 | Recruiting | Bristol-Myers Squibb | 470 | 2025-09-30 | 2026-07-29 |
| Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma Dato-DXd, Carboplatin, Cisplatin - Urothelial Cancer, Bladder Cancer | Phase 2 / Phase 3 | Recruiting | Daiichi Sankyo | 630 | 2025-09-26 | 2026-08-20 |
| Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Avelumab, Lorlatanib, Talazoparib - Advanced Malignancies, NSCLC | Phase 3 | Active not recruiting | Pfizer | 77 | 2021-09-29 | 2026-10-20 |
| Efficacy and Safety of VasoClip® vs. WeckClip® for Robotic Urologic Surgery VasoClip®, WeckClip® - Prostate Cancer (Adenocarcinoma), Kidney Cancers | Phase 3 | Completed | Incheon St.Mary's Hospital | 40 | 2020-05-07 | 2026-02-17 |
| Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer Enfortumab vedotin, Pembrolizumab, Cisplatin - Urothelial Cancer | Phase 3 | Active not recruiting | Astellas Pharma Global Development, Inc. | 886 | 2020-03-30 | 2026-05-29 |
| A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301) Enfortumab Vedotin, Docetaxel, Vinflunine - Ureteral Cancer, Urothelial Cancer | Phase 3 | Completed | Astellas Pharma Global Development, Inc. | 608 | 2018-06-27 | 2026-01-09 |
| A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations Erdafitinib, Vinflunine, Docetaxel - Urothelial Cancer | Phase 3 | Active not recruiting | Janssen Research & Development, LLC | 629 | 2018-03-23 | 2026-09-25 |
| Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer Nivolumab, Ipilimumab, Gemcitabine - Urothelial Cancer | Phase 3 | Active not recruiting | Bristol-Myers Squibb | 1314 | 2017-03-24 | 2026-03-06 |
| A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) Avelumab, Best Supportive Care, Following the planned interim analysis for this study: Avelumab - Urothelial Cancer | Phase 3 | Completed | Pfizer | 700 | 2016-04-25 | 2024-03-27 |
| Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer MEDI4736 (Durvalumab), Tremelimumab, Cisplatin - Urothelial Cancer | Phase 3 | Active not recruiting | AstraZeneca | 1126 | 2015-11-02 | 2026-07-14 |
| A Study of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel, or Vinflunine for Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045) pembrolizumab, paclitaxel, vinflunine - Urothelial Cancer | Phase 3 | Completed | Merck Sharp & Dohme LLC | 542 | 2014-10-22 | 2021-09-20 |
Urinary Bladder Neoplasms (7) · Carcinoma, Transitional Cell (3) · Neoplasms (2) · Urologic Neoplasms (2) · Adenocarcinoma (1) · Female Urogenital Diseases (1) · Kidney Neoplasms (1) · Male Urogenital Diseases (1) · Neoplasm Metastasis (1) · Neoplasms by Site (1) · Ovarian Neoplasms (1) · Parkinson Disease 4, Autosomal Dominant Lewy Body (1) · Prostatic Neoplasms (1) · Ureteral Neoplasms (1) · Urinary Bladder Diseases (1)
Female Urogenital Diseases and Pregnancy Complications (9) · Female Urogenital Diseases (8) · Neoplasms by Site (8) · Urogenital Diseases (8) · Urogenital Neoplasms (8) · Male Urogenital Diseases (7) · Neoplasms (7) · Urologic Diseases (7) · Urinary Bladder Diseases (6) · Urologic Neoplasms (6) · Carcinoma (4) · Neoplasms by Histologic Type (4) · Neoplasms, Glandular and Epithelial (4) · Genital Diseases (2) · Adnexal Diseases (1)
Cisplatin (7) · Gemcitabine (7) · Carboplatin (6) · pembrolizumab (4) · Docetaxel (3) · enfortumab vedotin (3) · vinflunine (3) · Paclitaxel (2) · avelumab (2) · Axitinib (1) · Fluorouracil (1) · Ipilimumab (1) · Mitomycin (1) · Nivolumab (1) · Pemetrexed (1)
Astellas Pharma Global Development, Inc. (3) · Bristol-Myers Squibb (2) · Pfizer (2) · AstraZeneca (1) · Daiichi Sankyo (1) · Incheon St.Mary's Hospital (1) · Janssen Research & Development, LLC (1) · Merck Sharp & Dohme LLC (1) · SystImmune Inc. (1)
United States (11) · Canada (9) · France (9) · Italy (9) · Japan (9) · South Korea (9) · Australia (8) · Spain (8) · Taiwan (8) · Belgium (7) · Germany (7) · Israel (7) · Netherlands (7) · Russia (7) · United Kingdom (7)
Jimmy Liu Zhao, MD, PhD (1) · John Lu, MD (1) · Zejing Wang, MD, PhD (1) · Zejing Wang, MD/PhD (1)
PMID 26454620, PMID 28212060, PMID 29562804, PMID 29590008, PMID 31050707, PMID 31395089, PMID 32945632, PMID 32971005, PMID 33577729, PMID 34893775, PMID 34973108, PMID 35101941, PMID 35247908, PMID 35416053, PMID 35654659, PMID 36041086, PMID 36494006, PMID 37019764, PMID 37071838, PMID 37121850, PMID 37149458, PMID 37870920, PMID 37870949, PMID 37884606, PMID 38418343, PMID 38446675, PMID 38446680, PMID 38485615, PMID 38728337, PMID 40037029, PMID 40449498, PMID 41015742, PMID 41039930, PMID 41563650, PMID 41925239, PMID 42142358
2015 (2), 2017 (2), 2023 (2), 2014 (1), 2016 (1), 2019 (1)