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

- 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

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

- 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.