COMBI-d — A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-Mutant Melanoma

Phase 3 · 2015 · Melanoma

Design

Double-blind randomized trial of dabrafenib plus trametinib vs. dabrafenib plus placebo.

Population

Previously untreated unresectable stage IIIC/IV BRAF V600E/K-mutant melanoma.

Primary Endpoint

progression-free survival (PFS)

Key Result

5-year pooled COMBI-d/v analysis of dabrafenib+trametinib: pooled median OS 25.9 mo, 5-yr OS 34% (4-yr 37%), 5-yr PFS 19% (4-yr 21%); complete response in 19%, associated with markedly improved long-term survival.

Guideline Impact

NCCN category 1 for BRAF V600-mutant advanced melanoma