TriangleNCT02632409 · CITED IN SOURCE DOCUMENTS
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
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2026-07-30
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Disease Free Survival (DFS)
Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
Non-Urothelial Tract Recurrence Free Survival
Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression ≥ 1% Population
Overall Survival
Overall Survival in Participants With PD-L1 Expression ≥ 1%
Disease Specific Survival
Disease Specific Survival in Participants With PD-L1 Expression ≥ 1%
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Nivolumab dose as specified
- intervention Names
- Biological: Nivolumab
- label
- Nivolumab
- type
- EXPERIMENTAL
- description
- Placebo dose as specified
- intervention Names
- Other: Placebo
- label
- Placebo
- type
- PLACEBO_COMPARATOR
- interventions
- arm Group Labels
- Nivolumab
- name
- Nivolumab
- type
- BIOLOGICAL
- arm Group Labels
- Placebo
- name
- Placebo
- type
- OTHER
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- TRIPLE
- who Masked
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 709
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- 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.
- measure
- Disease Free Survival (DFS)
- time Frame
- 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.
- measure
- Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
- time Frame
- approximately up to 48 months
- secondary Outcomes
- description
- The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
- measure
- Non-Urothelial Tract Recurrence Free Survival
- time Frame
- up to 53 months
- description
- The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
- measure
- Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression ≥ 1% Population
- time Frame
- up to 53 months
- description
- the time from randomization to the date of death from any cause.
- measure
- Overall Survival
- time Frame
- on going
- description
- the time from randomization to the date of death from any cause.
- measure
- Overall Survival in Participants With PD-L1 Expression ≥ 1%
- time Frame
- on going
- description
- the time from randomization to the date of death due to disease (urothelial cancer).
- measure
- Disease Specific Survival
- time Frame
- on going
- description
- the time from randomization to the date of death due to disease (urothelial cancer).
- measure
- Disease Specific Survival in Participants With PD-L1 Expression ≥ 1%
- time Frame
- on going
Full study description
- brief Summary
- 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.
Source references
- references
- citation
- Galsky 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
- type
- DERIVED
- citation
- Geynisman 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
- type
- DERIVED
- citation
- Galsky 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
- type
- DERIVED
- citation
- Bajorin 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
- type
- DERIVED
- citation
- Witjes 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.
- pmid
- 35288066
- type
- DERIVED
- citation
- Bajorin 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, Neif Antonio J Jr, Tupikowski K, Toms L, Fischer BS, Qureshi A, Collette S, Unsal-Kacmaz K, Broughton E, Zardavas D, Koon HB, Galsky MD. Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma. N Engl J Med. 2021 Jun 3;384(22):2102-2114. doi: 10.1056/NEJMoa2034442.
- pmid
- 34077643
- type
- DERIVED
- see Also Links
- label
- BMS Clinical Trial Information
- label
- BMS Clinical Trial Patient Recruiting
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice