Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma

Inclusion Criteria

• Diagnosis of locally advanced, unresectable or metastatic cutaneous or melanoma of unknown primary AJCC Stage IIIC or IV (uveal and mucosal melanoma are excluded)
• Presence of NRAS Q61 mutation in tumor tissue prior to randomization as determined by a Novartis designated central laboratory
• Naïve untreated patients or patients who have progressed on or after any number of prior lines of immunotherapy for unresectable locally advanced or metastatic melanoma
• Evidence of at least one measurable lesion as detected by radiological or photographic methods
• Adequate bone marrow, organ function, cardiac and laboratory parameters
• Normal functioning of daily living activities

Exclusion Criteria

• Any untreated CNS metastases
• Uveal or mucosal melanoma
• History of or current evidence of retinal vein occlusion (RVO) or risk factors of RVO
• Patients with washout period < 6 weeks from the last dose of ipilimumab or other immunotherapy.
• Previous systemic chemotherapy for unresectable locally advanced or metastatic melanoma.
• History of Gilbert's syndrome
• Prior therapy with a MEK- inhibitor
• Impaired cardiovascular function or clinically significant cardiovascular diseases
• Uncontrolled arterial hypertension despite medical treatment
• HIV positive or active Hepatitis A or B
• Impairment of gastrointestinal function
• Patients who have undergone major surgery or radiotherapy ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such procedure;
• Patients with neuromuscular disorders that are associated with elevated CK.
• Pregnant or nursing (lactating) women
• Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study

Other protocol-defined inclusion/exclusion criteria may apply