Expanded Access of MK-3475 in Metastatic Melanoma Patients with Limited to No Treatment Options
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
View more details from ClinicalTrials.gov.
For more information about a clinical trial, clinical trial eligibility, or informed consent, contact our research nurses by phone or email:
Please Note: Any eligibility criteria noted are subject to change. Our research nurses can provide you with the most current eligibility and exclusion criteria. Any study involvement to be undertaken must ultimately be determined on an individual basis.