Clinical trial · Interventional
A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney
A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse
NCT03138512CI-TRIAL-00083864CheckMate 914completedPhase 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 nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.
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 |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ipilimumab | Biological | Ipilimumab | ALIAS |
| ipilimumab placebo | Drug | — | UNRESOLVED |
| nivolumab | Biological | Nivolumab | ALIAS |
| nivolumab placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Part A, Arm A: nivolumab + ipilimumab
- interventionNames
- Biological: nivolumab
- Biological: ipilimumab
- type
- PLACEBO_COMPARATOR
- label
- Part A, Arm B: nivolumab placebo + ipilimumab placebo
- interventionNames
- Drug: nivolumab placebo
- Drug: ipilimumab placebo
- type
- EXPERIMENTAL
- label
- Part B, Arm A: nivolumab + ipilimumab
- interventionNames
- Biological: nivolumab
- Biological: ipilimumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy * Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0 * Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features * Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 * Women must agree to follow methods of contraception, if applicable Exclusion Criteria: * Participants with an active known or suspected autoimmune disease * Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways * Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation * History of allergy or hypersensitivity to study drug components * Participants with a condition requiring systemic treatment with corticosteroids * Participants who have received a live/attenuated vaccine within 30 days of first treatment Other protocol-defined inclusion/exclusion criteria apply
References
Publications (3)
- DERIVEDMotzer RJ, Bex A, Russo P, Tomita Y, Cutuli HJ, Rojas C, Gross-Goupil M, Schinzari G, Melichar B, Barthelemy P, Ruiz Garcia A, Sosman J, Grimm MO, Goh JC, Suarez C, Kollmannsberger CK, Nair SG, Shuch BM, Huang J, Simsek B, Spiridigliozzi J, Lee CW, van Kooten Losio M, Grunwald V. Adjuvant Nivolumab for Localized Renal Cell Carcinoma at High Risk of Recurrence After Nephrectomy: Part B of the Randomized, Placebo-Controlled, Phase III CheckMate 914 Trial. J Clin Oncol. 2025 Jan 10;43(2):189-200. doi: 10.1200/JCO.24.00773. Epub 2024 Sep 20. PMID 39303200
- DERIVEDMotzer RJ, Russo P, Grunwald V, Tomita Y, Zurawski B, Parikh O, Buti S, Barthelemy P, Goh JC, Ye D, Lingua A, Lattouf JB, Albiges L, George S, Shuch B, Sosman J, Staehler M, Vazquez Estevez S, Simsek B, Spiridigliozzi J, Chudnovsky A, Bex A. Adjuvant nivolumab plus ipilimumab versus placebo for localised renal cell carcinoma after nephrectomy (CheckMate 914): a double-blind, randomised, phase 3 trial. Lancet. 2023 Mar 11;401(10379):821-832. doi: 10.1016/S0140-6736(22)02574-0. Epub 2023 Feb 9. PMID 36774933
- DERIVEDMarconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7. PMID 33526329