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

Korábbi kezelés

• 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
• Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
• Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to enrollment
• Radiation therapy within 4 weeks prior to start of study treatment

Más betegség

• Any history of CNS metastases
• Active autoimmune disease, and/or history of autoimmune disease(s) that required treatment
  • Parts 2 \& 3: Biomarker cohort \& double-blind, randomized, placebo-controlled part
• Active autoimmune disease, and/or history of autoimmune disease(s) that required treatment
  • Other protocol-defined Inclusion/Exclusion may apply.

Egyéb

• Part 1: Safety run-in
• Subjects with uveal or mucosal melanoma
• Subjects with uveal or mucosal melanoma
• Clinically active cerebral melanoma metastasis.

• 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