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