KEYNOTE-022 part 3: a randomized, double-blind, phase 2 study of pembrolizumab, dabrafenib, and trametinib in -mutant melanoma.

Background: In the KEYNOTE-022 study, pembrolizumab with dabrafenib and trametinib (triplet) improved progression-free survival (PFS) versus placebo with dabrafenib and trametinib (doublet) without reaching statistical significance. Mature results on PFS, duration of response (DOR), and overall survival (OS) are reported.

Methods: The double-blind, phase 2 part of KEYNOTE-022 enrolled patients with previously untreated -mutated advanced melanoma from 22 sites in seven countries.

Dabrafenib, trametinib and pembrolizumab or placebo in BRAF-mutant melanoma.

Blocking programmed death 1 (PD-1) may enhance the durability of anti-tumor responses that are induced by the combined inhibition of BRAF and MEK. Here we performed a randomized phase 2 trial ( NCT02130466 ), in which patients with treatment-naive BRAF-mutant, advanced melanoma received the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib together with the PD-1-blocking antibody pembrolizumab (triplet; n = 60) or placebo (doublet; n = 60). The primary end point of progression-free survival was numerically improved in the triplet group-16.