Study Comparing Combination of LGX818 Plus MEK162 and LGX818 Monotherapy Versus Vemurafenib in BRAF Mutant Melanoma (COLUMBUS)

A prospective, randomized, open label, multi-center, parallel group, 3-arm phase III study comparing the efficacy and safety of both, LGX818 plus MEK162 and LGX818 monotherapy, as compared to vemurafenib in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized 1:1:1 to one of 3 treatment arms: 1) LGX818 plus MEK162 (denoted as Combination arm), 2) LGX818 monotherapy (denoted as LGX818 arm), 3) vemurafenib.