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

Trial Profile

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Oct 2017

At a glance

  • Drugs PDR 001 (Primary) ; Dabrafenib; Trametinib
  • Indications Malignant melanoma
  • Focus Adverse reactions; Biomarker; Pharmacodynamics; Therapeutic Use
  • Acronyms COMBI-i
  • Sponsors Novartis; Novartis Pharma A.G.; Novartis Pharmaceuticals
  • Most Recent Events

    • 13 Oct 2017 Planned End Date changed from 31 Dec 2019 to 24 Feb 2020.
    • 12 Sep 2017 Trial design of the study presented at the 42nd European Society for Medical Oncology Congress.
    • 11 Sep 2017 Trial design presented at the 2017 European Society for Medical Oncology Congress (ESMO) in Madrid, Spain, according to a Novartis media release.
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