A Phase III, Randomized, Double-blinded Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to Dabrafenib and Placebo as First-line Therapy in Subjects With Unresectable (Stage IIIC) or Metastatic (Stage IV) BRAF V600E/K Mutation-positive Cutaneous Melanoma.

Trial Profile

A Phase III, Randomized, Double-blinded Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to Dabrafenib and Placebo as First-line Therapy in Subjects With Unresectable (Stage IIIC) or Metastatic (Stage IV) BRAF V600E/K Mutation-positive Cutaneous Melanoma.

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Oct 2017

At a glance

  • Drugs Dabrafenib (Primary) ; Trametinib (Primary)
  • Indications Malignant melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms COMBI-d
  • Sponsors GlaxoSmithKline; Novartis Pharma
  • 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
    • 31 Aug 2017 Planned End Date changed from 1 Jan 2018 to 15 Jul 2018.
    • 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