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CheckMate 76K

Adjuvant nivolumab versus placebo in resected stage IIB/C melanoma

Phase 3N = 790NCT04099251

Population
Patients with resected stage IIB/C melanoma
Design
Double-blind, randomised 2:1 phase 3 trial stratified by tumour category. Nivolumab 480 mg or placebo every 4 weeks for 12 months. Primary endpoint investigator-assessed recurrence-free survival; secondary endpoints included distant metastasis-free survival and safety.
Primary endpoint
RFS
Arms
  • Nivolumab (experimental, n = 526): Nivolumab 480 mg every 4 weeks, 12 months
  • Placebo (control, n = 264): Placebo every 4 weeks, 12 months
People
Kirkwood JM, senior author Long GV
RFSHR 0.42 (95% CI 0.30–0.59)Δ 12-month RFS+9.6 pointsDMFSHR 0.47 (95% CI 0.30–0.72)
Show the numbers
Results reported for CheckMate 76K
EndpointAnalysisNivolumabPlaceboEffect
RFSprimaryKirkwood 202389% at 12 mo79.4% at 12 moHR 0.42 (95% CI 0.30–0.59)P<0.0001Minimum follow-up 7.8 months. Benefit observed across subgroups (abstract). Treatment-related grade 3/4 adverse events 10.3% (nivolumab) vs 2.3% (placebo); one treatment-related death (0.2%) with nivolumab.
DMFSprimaryKirkwood 2023——HR 0.47 (95% CI 0.30–0.72)Secondary endpoint at the same analysis (minimum follow-up 7.8 months). No rates are given in the abstract.
Results reported for CheckMate 76K
EndpointAnalysisNivolumabPlaceboEffect
RFSprimaryKirkwood 202389% at 12 mo79.4% at 12 moHR 0.42 (95% CI 0.30–0.59)P<0.0001Minimum follow-up 7.8 months. Benefit observed across subgroups (abstract). Treatment-related grade 3/4 adverse events 10.3% (nivolumab) vs 2.3% (placebo); one treatment-related death (0.2%) with nivolumab.
DMFSprimaryKirkwood 2023——HR 0.47 (95% CI 0.30–0.72)Secondary endpoint at the same analysis (minimum follow-up 7.8 months). No rates are given in the abstract.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
RFSDMFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
RFS0.420.3–0.59
DMFS0.470.3–0.72
Primary publication: Kirkwood JM, Del Vecchio M, Weber J, Hoeller C, Grob JJ, Mohr P, et al. Adjuvant nivolumab in resected stage IIB/C melanoma: primary results from the randomized, phase 3 CheckMate 76K trial. Nat Med. 2023;29(11):2835-2843. PubMedDOI

Appears in

Sources

  1. Kirkwood JM, Del Vecchio M, Weber J, Hoeller C, Grob JJ, Mohr P, et al. Adjuvant nivolumab in resected stage IIB/C melanoma: primary results from the randomized, phase 3 CheckMate 76K trial. Nat Med. 2023;29(11):2835-2843.

    PubMedDOI