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CheckMate 914

Adjuvant nivolumab plus ipilimumab versus placebo for localised renal cell carcinoma after nephrectomy (CheckMate 914), part A

Phase 3N = 816NCT03138512

Population
Localised clear cell renal cell carcinoma at high risk of relapse after radical or partial nephrectomy.
Design
Double-blind, randomised (1:1) phase 3 trial, part A, in 145 hospitals and cancer centres in 20 countries: patients with nephrectomy 4 to 12 weeks before randomisation received nivolumab 240 mg every 2 weeks for 12 doses plus ipilimumab 1 mg/kg every 6 weeks for four doses, or matching placebo. Primary endpoint disease-free survival by masked independent central review. The ClinicalTrials.gov record lists 1641 enrolled across parts A and B; the paper reports part A.
Primary endpoint
DFS
Arms
  • Nivolumab plus ipilimumab (experimental, n = 405): Nivolumab 240 mg every 2 weeks for 12 doses plus ipilimumab 1 mg/kg every 6 weeks for four doses
  • Placebo (control, n = 411): Matching placebo
People
Motzer RJ
DFSHR 0.92 (95% CI 0.71–1.19)
Show the numbers
Results reported for CheckMate 914
EndpointAnalysisNivolumab plus ipilimumabPlaceboEffect
DFSDisease-free survival according to masked independent central review.primarymedian follow-up 37 monthsMotzer 2023—median 50.7 monthsHR 0.92 (95% CI 0.71–1.19)P=0.53Median DFS was not reached with nivolumab plus ipilimumab; the 95% CI of the placebo median was 48.1 to not estimable. Only 61 events had occurred for the planned interim overall survival analysis (33 vs 28), so it was not reached. Grade 3-5 adverse events occurred in 155 (38%) of 404 treated patients on nivolumab plus ipilimumab and 42 (10%) of 407 on placebo; four deaths were attributed to nivolumab plus ipilimumab.
Results reported for CheckMate 914
EndpointAnalysisNivolumab plus ipilimumabPlaceboEffect
DFSDisease-free survival according to masked independent central review.primarymedian follow-up 37 monthsMotzer 2023—median 50.7 monthsHR 0.92 (95% CI 0.71–1.19)P=0.53Median DFS was not reached with nivolumab plus ipilimumab; the 95% CI of the placebo median was 48.1 to not estimable. Only 61 events had occurred for the planned interim overall survival analysis (33 vs 28), so it was not reached. Grade 3-5 adverse events occurred in 155 (38%) of 404 treated patients on nivolumab plus ipilimumab and 42 (10%) of 407 on placebo; four deaths were attributed to nivolumab plus ipilimumab.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
DFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
DFS0.920.71–1.19
Illustrative — modelled from reported values, not trial data. DFS, primary.
0%25%50%75%100%020406080100120Months (modelled)
  • Placebo (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsPlacebo
0100.0%
3264.6%
6342.3%
9527.3%
12717.6%
Primary publication: Motzer RJ, Russo P, Grünwald V, Tomita Y, Zurawski B, Parikh O, et al. Adjuvant nivolumab plus ipilimumab versus placebo for localised renal cell carcinoma after nephrectomy (CheckMate 914): a double-blind, randomised, phase 3 trial. Lancet. 2023;401(10379):821-832. PubMedDOI

Appears in

Sources

  1. Motzer RJ, Russo P, Grünwald V, Tomita Y, Zurawski B, Parikh O, et al. Adjuvant nivolumab plus ipilimumab versus placebo for localised renal cell carcinoma after nephrectomy (CheckMate 914): a double-blind, randomised, phase 3 trial. Lancet. 2023;401(10379):821-832.

    PubMedDOI