A Randomized Phase III, Open Label, Multicenter, Two-arm Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Patients With Advanced Unresectable or Metastatic NRAS Mutation-positive Melanoma

Trial Profile

A Randomized Phase III, Open Label, Multicenter, Two-arm Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Patients With Advanced Unresectable or Metastatic NRAS Mutation-positive Melanoma

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Jun 2017

At a glance

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

    • 29 Mar 2017 Planned End Date changed from 1 Mar 2017 to 1 Mar 2018.
    • 19 Mar 2017 According to Array BioPharma media release, based on communications with the FDA the company has withdrawn its new drug application (NDA) of binimetinib as monotherapy for the treatment of NRAS-mutant melanoma.
    • 19 Mar 2017 According to Array BioPharma media release, the company concluded that the clinical results from this study would not be sufficient to support NDA approval of the treatment of NRAS-mutant melanoma.
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