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