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: 04 Aug 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

    • 05 Jul 2017 According to an Array BioPharma media release, further results from COLUMBUS Part 2 will be presented at a medical meeting during the second half of 2017.
    • 05 Jul 2017 According to an Array BioPharma media release, based on the data from this trial the company has submitted two New Drug Applications (NDAs) to the U.S. FDA to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma.
    • 10 Jun 2017 Biomarkers information updated
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