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: 27 Jul 2018

At a glance

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

    • 27 Jul 2018 Finland was a planned location for this study.
    • 27 Jul 2018 According to a Novartis media release, Axel Hauschild is a lead investigator in this trial.
    • 27 Jul 2018 According to a Novartis media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resection. The CHMP recommendation is based on findings from this study.
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