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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...

Mise à jour : Il y a 4 ans
Référence : EUCTR2016-002794-35

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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Extrait

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

Critère d'inclusion

  • unresectable or metastatic BRAF V600 mutant melanoma

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