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: 06 Apr 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

    • 30 Mar 2018 Planned End Date changed from 31 Dec 2030 to 15 Mar 2023.
    • 07 Mar 2018 Planned End Date changed from 15 Mar 2023 to 31 Dec 2030.
    • 22 Dec 2017 According to a Novartis media release, the US FDA has accepted supplemental New Drug Application (sNDA) for filing and granted Priority Review designation for Tafinlar in combination with Mekinist for the adjuvant treatment of patients with stage III melanoma with PRAF V600E or V600K mutations. The Priority Review designation was based on data from this trial.
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