KEYNOTE-006 — Study to Evaluate the Safety and Efficacy of Two Different Dosing Schedules of Pembrolizumab Compared to Ipilimumab in Participants With Advanced Melanoma

Phase 3 · 2015 · Melanoma

Design

Randomized trial of pembrolizumab every 2 weeks or every 3 weeks vs. ipilimumab in advanced melanoma.

Population

Advanced (unresectable stage III/IV) melanoma with up to one prior systemic therapy, ipilimumab-naive.

Primary Endpoint

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

Key Result

7-year final analysis (median follow-up 85.3 mo): median OS 32.7 vs 15.9 mo (HR 0.70); 7-yr OS 37.8% vs 25.3%; median PFS 9.4 vs 3.8 mo (7-yr mPFS 23.8% vs 13.3%).

Guideline Impact

NCCN category 1 for first-line advanced melanoma