COMBI-AD: A Phase III Randomized Double Blind Study of Dabrafenib (GSK2118436) in COMBInation With Trametinib (GSK1120212) Versus Two Placebos in the ADjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection

Trial Profile

COMBI-AD: A Phase III Randomized Double Blind Study of Dabrafenib (GSK2118436) in COMBInation With Trametinib (GSK1120212) Versus Two Placebos in the ADjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Oct 2017

At a glance

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

    • 23 Oct 2017 According to a Novartis media release, based on the data from this trial the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following complete resection.
    • 11 Sep 2017 Results from this trial published in the New England Journal of Medicine, according to a Novartis media release.
    • 11 Sep 2017 Results from this trial presented at the 2017 European Society for Medical Oncology annual Congress (ESMO) in Madrid,Spain, according to a Novartis media release.
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