drugset / Trial / NCT02632409
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
Phase 3
Active not recruiting
709 enrolled
Bristol-Myers Squibb
Ono Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2016-03-22
- Primary completion
- 2020-07-17
- Completion
- 2027-05-27
Outcome
Met primary endpoint
paper The primary end points of disease-free survival (DFS) in intent-to-treat (ITT) and tumor PD-L1 expression ≥1% populations were met. PMID 39393026 ↗
registry analysis (superiority test); Placebo vs Nivolumab; p = 0.0008; Hazard Ratio (HR) 0.70 (98.22% CI 0.55 to 0.90) NCT02632409 ↗
registry analysis (superiority test); Placebo vs Nivolumab; p = 0.0005; Hazard Ratio (HR) 0.54 (98.72% CI 0.35 to 0.84) NCT02632409 ↗
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |