Study of safety and efficacy of PDR001 in combination with dabrafenib and trametinib in patients with a genetically distinct subtype of unresectable or metastatic melanoma, which is characterised by a mutation in the BRAF gene

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 538

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
Other protocol-defined Inclusion criteria may apply.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 409
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 129

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, placebocontrolled 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 Exclusion may apply.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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Study of safety and efficacy of PDR001 in combination with dabrafenib and trametinib in patients with a genetically distinct subtype of unresectable or metastatic melanoma, which is characterised by a mutation in the BRAF gene

Recruitment & Eligibility

Study & Design

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