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

Official Title

A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma


To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (Spartalizumab (PDR001)), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma

Trial Description

Primary Outcome:

  • Safety Run-In (Part 1): Incidence of dose limiting toxicities (DLTs)
  • Biomarker cohort (Part 2): Immune microenvironment and biomarker modulation
  • Randomized (Part 3): Progression-Free Survival (PFS), investigator assessed by RECIST 1.1
Secondary Outcome:
  • Overall survival
  • Overall response rate
  • Duration of response
  • Disease control rate
  • Global health status/quality of life score of the EORTC QLQ-C30
  • Global health status/quality of life score of the FACT-M subscale
  • Global health status/quality of life score of the EQ-5D-5L
  • Time to 10 point definitive deterioration in overall quality of life score from EORTC QLQ-C30
  • PFS by PD-L1 expression
  • OS by PD-L1 expression

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society