Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma
Status:
Completed
Trial end date:
2019-06-04
Target enrollment:
Participant gender:
Summary
Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the
efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in
patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61
mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be
performed at a central laboratory. Only those patients with Q61 mutation per central
laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will
be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified
according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0
versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This
study will use an Interactive Response Technology (IRT). The primary end point of the study
is progression-free survival. Key secondary end point is overall survival