A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma

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

The study will assess the safety and efficacy of single-agent MEK162 in adult patients with locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring BRAFV600E 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.