A 2-part phase III randomized, open label, multicenter study of LGX818 plus MEK162 versus vemurafenib and LGX818 monotherapy in patients with unresectable or metastatic BRAF V600 mutant melanoma

Trial Profile

A 2-part phase III randomized, open label, multicenter study of LGX818 plus MEK162 versus vemurafenib and LGX818 monotherapy in patients with unresectable or metastatic BRAF V600 mutant melanoma

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2017

At a glance

  • Drugs Binimetinib (Primary) ; Encorafenib (Primary) ; Vemurafenib
  • Indications Malignant melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms COLUMBUS
  • Sponsors Array BioPharma; Novartis
  • Most Recent Events

    • 31 Oct 2017 According to an Array BioPharma media release, the FDA informed that, based on its preliminary review of the applications, it has not identified any potential review issues, and that it is not currently planning to hold an advisory committee meeting to discuss these NDAs.
    • 12 Sep 2017 Results from part-2 of the study, presented at the 42nd European Society for Medical Oncology Congress.
    • 12 Sep 2017 Results assessing hospitalization rates in Part 1 of the study (n=577) presented at the 42nd European Society for Medical Oncology Congress
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