CheckMate-067
Nivolumab + Ipilimumab vs Monotherapy in Advanced Melanoma
Patient / Population Intervention / Exposure Comparison Outcome
In 945 patients with untreated advanced melanoma, nivolumab + ipilimumab or nivolumab improved overall survival compared with ipilimumab.
N
945
Design
Double-blind RCT, three arms
Endpoint
PFS and OS
Relevance
1
ResultMedian PFS 11.5 mo (nivo+ipi) vs 6.9 (nivo) vs 2.9 (ipi); HR vs ipi 0.42 (99.5% CI 0.31–0.57, P<0.001) combo, 0.57 (99.5% CI 0.43–0.76, P<0.001) nivo.
Larkin J, et al. N Engl J Med. 2015;373(1):23-34. 10.1056/NEJMoa1504030
Discussion & critique
Longest reported median OS in any advanced-melanoma phase-3 trial; foundational benchmark for combination checkpoint blockade. Combination toxicity is substantial.