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

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Extract

Part 1: Safety run-in To determine the recommended regimen of PDR001 in combination with dabrafenib and trametinib for the randomized part (part 3) Part 2: Biomarker cohort To evaluate changes in the immune microenvironment and biomarker modulations upon treatment with PDR001 in combination with dabrafenib and trametinib Part 3: Double-blind, randomized, placebo-controlled part To compare the anti-tumor activity of PDR001 in combination with dabrafenib and trametinib versus placebo plus dabrafenib and trametinib as measured by PFS per investigator’s assessment according to RECIST 1.1

Inclusion criteria

unresectable or metastatic BRAF V600 mutant melanoma

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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...