Study of safety and efficacy of PDR001 in combination with dabrafenib and trametinib in patients with advanced melanoma

Recruitment & Eligibility

Status: completed

Sex: All

Target Recruitment: 11

Inclusion Criteria

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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Recruitment & Eligibility

Study & Design

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