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: 13 Oct 2017

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

    • 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
    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top