drugset / Trial / NCT03036098
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
Phase 3
Active not recruiting
1314 enrolled
Bristol-Myers Squibb
Ono Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.
Timeline
- Start
- 2017-03-24
- Primary completion
- 2024-08-30
- Completion
- 2026-05-15
Publications
- Tomita Y, Ye DW, Fujii A, Takeuchi N. Nivolumab plus gemcitabine-cisplatin for previously untreated unresectable or metastatic urothelial carcinoma: an Asian subgroup analysis from the global phase 3 CheckMate 901 trial. Urol Oncol. 2025 Dec;43(12):696.e9-696.e16. doi: 10.1016/j.urolonc.2025.08.022. Epub 2025 Sep 26.
- van der Heijden MS, Sonpavde G, Powles T, Necchi A, Burotto M, Schenker M, Sade JP, Bamias A, Beuzeboc P, Bedke J, Oldenburg J, Chatta G, Urun Y, Ye D, He Z, Valderrama BP, Ku JH, Tomita Y, Filian J, Wang L, Purcea D, Patel MY, Nasroulah F, Galsky MD; CheckMate 901 Trial Investigators. Nivolumab plus Gemcitabine-Cisplatin in Advanced Urothelial Carcinoma. N Engl J Med. 2023 Nov 9;389(19):1778-1789. doi: 10.1056/NEJMoa2309863. Epub 2023 Oct 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | — | — |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Comparator | Carboplatin | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Gemcitabine | Small molecule | — | — |