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.