CheckMate 067 — Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma

Phase 3 · 2015 · Melanoma

Design

Three-arm randomized trial: nivolumab plus ipilimumab vs. nivolumab monotherapy vs. ipilimumab monotherapy in untreated advanced disease.

Population

Previously untreated unresectable stage III/IV melanoma, any BRAF status.

Primary Endpoint

progression-free survival (PFS) and overall survival (OS)

Key Result

Final 10-year analysis: median OS 71.9 (combo) vs 36.9 (nivo) vs 19.9 mo (ipi); combo-vs-ipi HR for death 0.53; melanoma-specific survival >120 mo with combo (37% alive at 10 years).

Guideline Impact

NCCN category 1 for first-line advanced/metastatic melanoma