A Randomized Phase III, Open Label, Multicenter, Two-arm Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Patients With Advanced Unresectable or Metastatic NRAS Mutation-positive Melanoma

Inclusion Criteria:

- Diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma (AJCC
Stage IIIC or IV)

- Presence of NRAS Q61 mutation in tumor tissue prior to randomization

- Naïve untreated patients or patients who have progressed on or after prior first-line
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 active/non-stable brain lesion

- Non-cutaneous melanoma

- History of or current evidence of central serous retinopathy (CSR), retinal vein
occlusion (RVO) or history of retinal degenerative disease.

Patients with washout period < 12 weeks from the last dose of ipilimumab or other
immunotherapy.

Previous 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 or gastrointestinal disease

- 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