A Phase III, Randomised, Open-label Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to the BRAF Inhibitor Vemurafenib in Subjects With Unresectable (Stage IIIc) or Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma

Trial Profile

A Phase III, Randomised, Open-label Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to the BRAF Inhibitor Vemurafenib in Subjects With Unresectable (Stage IIIc) or Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma

Discontinued
Phase of Trial: Phase III

Latest Information Update: 18 Apr 2018

At a glance

  • Drugs Dabrafenib (Primary) ; Trametinib (Primary) ; Vemurafenib
  • Indications Malignant melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms COMBI-v
  • Sponsors GlaxoSmithKline; Novartis Pharma A.G.
  • Most Recent Events

    • 18 Apr 2018 Results from CheckMate 067 and 069 studies and COMBI-d, COMBI-v, and coBRIM studies, presented at the 109th Annual Meeting of the American Association for Cancer Research
    • 01 Sep 2017 Pooled results of three-year landmark data retrospectively pooled for D + T patients in phase 3 trials (COMBI-d [NCT01584648]; COMBI-v [NCT01597908]) published in the European Journal of Cancer
    • 06 Jun 2017 Results assessing PD-L1 and CD8 expression (n=74) presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
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