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: 17 Sep 2018

At a glance

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

    • 31 Aug 2018 Biomarkers information updated
    • 27 Feb 2018 Planned End Date changed from 24 Feb 2020 to 13 Feb 2020.
    • 27 Feb 2018 Planned primary completion date changed from 12 Jul 2019 to 19 Jul 2019.
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