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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Jul 2022

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At a glance

  • Drugs Dabrafenib (Primary) ; Trametinib (Primary) ; Vemurafenib
  • Indications Malignant melanoma; Skin cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms COMBI-v
  • Sponsors GlaxoSmithKline; GSK; Novartis; Novartis Pharmaceuticals

    • Most Recent Events

    • 22 Jun 2022 According to a Food and Drug Administration media release, the Food and Drug Administration granted accelerated approval to dabrafenib in combination with trametinib for the treatment of adult and pediatric patients greater than equal to 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.
    • 02 Jul 2021 Results (n=1076) of pooled analysis charactering the incidence, patterns and management of pyrexia in patients receiving dabrafenib plus trametinib in clinical trials (NCT01336634, NCT01682083, NCT01584648, NCT01597908) published in the European Journal of Cancer
    • 09 Jun 2021 Results published in the Clinical Cancer Research

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