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

Summary:

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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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society