Clinical trial · Interventional
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
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
NCT03036098CI-TRIAL-00104920CheckMate901active not recruitingPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Ipilimumab | Biological | Ipilimumab | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm A: Investigational immunotherapy
- interventionNames
- Biological: Nivolumab
- Biological: Ipilimumab
- type
- ACTIVE_COMPARATOR
- label
- Arm B: Standard of care chemotherapy
- interventionNames
- Drug: Gemcitabine
- Drug: Cisplatin
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- Arm C: Investigational immunotherapy
- interventionNames
- Biological: Nivolumab
- Drug: Gemcitabine
- Drug: Cisplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological evidence of metastatic or surgically inoperable transitional cell cancer (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra * No prior systemic chemotherapy for metastatic or surgically inoperable urothelial cancer (UC) * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Women and men must agree to follow specific methods of contraception, if applicable Exclusion Criteria: * Disease that is suitable for local therapy administered with curative intent * Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with study participation or study drug administration or interfere with the interpretation of study results * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol-defined inclusion/exclusion criteria apply
References
Publications (2)
- DERIVEDTomita 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. PMID 41015742
- DERIVEDvan 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. PMID 37870949