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: 02 Aug 2017

At a glance

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

    • 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
    • 15 Nov 2016 Results of retrospective analysis from pooled data of BRF113220, COMBI-d and COMBI-v trials (n=617) published in the Lancet Oncology.
    • 11 Oct 2016 Results of 3 years efficacy and safety analysis (data cutoff :July 2016) presented at the 41st European Society for Medical Oncology Congress
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