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

Open to people ages 18 years and up

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 - 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 - 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

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
• Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
• Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
• Radiation therapy within 4 weeks prior to start of study treatment
• Active, known, suspected or a documented history of autoimmune disease

Parts 2 & 3: Biomarker cohort & double-blind, randomized, placebo-controlled part

• Subjects with uveal or mucosal melanoma
• Clinically active cerebral melanoma metastasis
• Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
• Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
• Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
• Radiation therapy within 4 weeks prior to start of study treatment
• Active, known, suspected or a documented history of autoimmune disease

Other protocol-defined Inclusion/Exclusion may apply.