A Phase II, Open-label Study to Assess the Safety and Efficacy of Oral MEK162 in Adults With Locally Advanced and Unresectable or Metastatic Malignant Cutaneous Melanoma, Harboring BRAFV600 or NRAS Mutations

Inclusion Criteria:

- Locally advanced or metastatic cutaneous melanoma AJCC Stage IIIB to IV, not
potentially curable with surgery

- BRAF or NRAS mutation in tumor tissue

- All patients enrolled should provide sufficient fresh or archival tumor sample at
baseline to enable confirmation of BRAF or NRAS mutations and the additional analyses
described in the protocol

- Evidence of measurable tumor disease as per RECIST

- WHO performance status of 0-2

- Adequate organ function and laboratory parameters

Exclusion Criteria:

- History or evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO)
or any eye condition that would be considered a risk factor for CSR or RVO

- Patients with unstable CNS metastasis

- Prior treatment with a MEK- inhibitor

- Impaired cardiovascular function

- HIV, active Hepatitis B, and/or active Hepatitis C infection

- Pregnant or nursing (lactating) women

- Women of child-bearing potential UNLESS they comply with protocol contraceptive
requirements

Other protocol-defined inclusion/exclusion criteria may apply.