A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

Inclusion criteria Part 1: Safety run-in * Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation * Aspartate transaminase (AST) \< 2.5× ULN and Alanine transaminase (ALT) \< 2.5× ULN * Measurable disease according to RECIST 1.1 * ECOG performance status ≤ 1 Part 2: Biomarker cohort * Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation * At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection * Measurable disease according to RECIST 1.1 * ECOG performance status ≤ 2 Part 3: Double-blind, randomized, placebo-controlled part * Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation * ECOG performance status ≤ 2 * Measurable disease according to RECIST 1.1 Exclusion Criteria: Part 1: Safety run-in * Subjects with uveal or mucosal melanoma * Any history of CNS metastases * Prior systemic anti-cancer treatment for unresectable or metastatic melanoma * Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to enrollmen * Radiation therapy within 4 weeks prior to start of study treatment * Active autoimmune disease, and/or history of autoimmune disease(s) that required treatment Parts 2 \& 3: Biomarker cohort \& double-blind, randomized, placebo-controlled part * Subjects with uveal or mucosal melanoma * Prior systemic anti-cancer treatment for unresectable or metastatic melanoma * Neoadjuvant and/or adjuvant therapy for me…