Clinical trial · Interventional
An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)
NCT02632409CI-TRIAL-00119922CheckMate 274completedPhase 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 the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive 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 |
|---|---|---|---|
| Various Advanced Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Biological | Nivolumab | ALIAS |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nivolumab
- description
- Nivolumab dose as specified
- interventionNames
- Biological: Nivolumab
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo dose as specified
- interventionNames
- Other: Placebo
Primary outcomes (2)
- measure
- Disease Free Survival (DFS)
- timeFrame
- approximately up to 48 months
- description
- The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis * Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days * Must have disease free status as determined by imaging within 4 weeks of dosing * Tumor tissue must be provided for biomarker analysis * Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy Exclusion Criteria: * Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy) * Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer * Subjects with active, known or suspected autoimmune disease * Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured * Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration * Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
References
Publications (6)
- DERIVEDGalsky MD, Bajorin DF, Tomita Y, Ye D, Agerbaek M, Enting D, Peer A, Milowsky M, Kobayashi K, Grimm MO, Stenner F, David JM, Li J, Chasalow SD, Nasroulah F, Apfel A, Unsal-Kacmaz K, Necchi A. Adjuvant nivolumab in muscle-invasive urothelial carcinoma: exploratory biomarker analysis of the randomized phase 3 CheckMate 274 trial. Nat Med. 2025 Sep;31(9):3062-3073. doi: 10.1038/s41591-025-03802-8. Epub 2025 Aug 7. PMID 40775055
- DERIVEDGeynisman DM, Chepynoga K, Yates G, Tate A, Kurt M, Patel MY, Teitsson S, Mitra S, Mamtani R. Estimating the Impact of Adjuvant Treatment With Nivolumab on Long-Term Survivorship Rates Compared With Surveillance in Muscle Invasive Urothelial Carcinoma: Mixture Cure Modeling Analyses of Disease-Free Survival From the Phase 3 CheckMate 274 Trial. Clin Genitourin Cancer. 2025 Jun;23(3):102335. doi: 10.1016/j.clgc.2025.102335. Epub 2025 Mar 17. PMID 40204616
- DERIVEDGalsky MD, Witjes JA, Gschwend JE, Milowsky MI, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat SF, Park SH, Agerbaek M, Jha G, Stenner F, Ye D, Giudici F, Dutta S, Askelson M, Nasroulah F, Zhang J, Brophy L, Bajorin DF. Adjuvant Nivolumab in High-Risk Muscle-Invasive Urothelial Carcinoma: Expanded Efficacy From CheckMate 274. J Clin Oncol. 2025 Jan;43(1):15-21. doi: 10.1200/JCO.24.00340. Epub 2024 Oct 11. PMID 39393026
- DERIVEDBajorin DF, Witjes JA, Gschwend JE, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat SF, Park SH, Ye D, Agerbaek M, Enting D, McDermott R, Gajate P, Peer A, Milowsky MI, Nosov A, Antonio JN Jr, Tupikowski K, Toms L, Fischer BS, Qureshi A, Collette S, Unsal-Kacmaz K, Broughton E, Zardavas D, Koon HB, Galsky MD. Treatment of muscle-invasive urothelial cancer with nivolumab (CheckMate 274 study): a plain language summary. Future Oncol. 2023 Feb;19(6):413-426. doi: 10.2217/fon-2022-1294. Epub 2023 Mar 15. PMID 36919916
- DERIVEDWitjes JA, Galsky MD, Gschwend JE, Broughton E, Braverman J, Nasroulah F, Maira-Arce M, Ye X, Shi L, Guo S, Hamilton M, Bajorin DF. Health-related Quality of Life with Adjuvant Nivolumab After Radical Resection for High-risk Muscle-invasive Urothelial Carcinoma: Results from the Phase 3 CheckMate 274 Trial. Eur Urol Oncol. 2022 Oct;5(5):553-563. doi: 10.1016/j.euo.2022.02.003. Epub 2022 Mar 11.