Conditions: Metastatic or Unresectable Cutaneous Melanoma
Keywords: Melanoma Cutaneous melanoma Skin disease Skin cancer Skin Neoplasms Neoplasm Metastasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 402
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: MEK162 intervention 2: Dacarbazine
Intervention descriptions: intervention 1: MEK162 will be administered as a fixed dose of 45 mg (3 x 15 mg tablets) BID, with a glass of water and taken with or without food. intervention 2: Patients randomized to dacarbazine will receive an IV infusion of dacarbazine 1000 mg/m2 over the course of 1 hour on day 1 and then every three weeks.

Protocol document: