Clinical trial · no report yet · Phase 3
CheckMate901
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
- NCT03036098 ↗
- Active not recruiting
- Bristol-Myers Squibb
- 297 commentary sources found
- Deep
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.
| Channel | Found | |
|---|---|---|
| X threads | 128 | |
| YouTube | 82 | |
| Podcasts | 82 | |
| X videos | 5 |
The trial
ClinicalTrials.gov- Official title
- A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer
- Phase
- Phase 3
- Status
- Active not recruiting
- Conditions
- Urothelial Cancer
- Interventions
- Nivolumab; Ipilimumab; Gemcitabine; Cisplatin; Carboplatin
- Arms
- Arm A: Investigational immunotherapy · Experimental
- Arm B: Standard of care chemotherapy · Active comparator
- Arm C: Investigational immunotherapy · Experimental
- Arm D: Standard of care chemotherapy · Active comparator
- Enrollment
- 1,314
- Primary outcomes
- Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Study
- Overall Survival (OS) in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Randomized Participants by Immunohistochemistry (IHC) for Primary Study
- Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-eligible Participants for Sub-study
- Overall Survival (OS) in Cisplatin-eligible Participants for Sub-study
- Sponsor
- Bristol-Myers Squibb with Ono Pharmaceutical Co., Ltd.
- Start
- Mar 24, 2017
- Primary completion
- Aug 30, 2024
- Results posted
- Yes
- Registry record
- NCT03036098 · updated Mar 6, 2026
Publications
linked from the registry- 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. PubMed 41015742
- 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. PubMed 37870949