Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma

Exclusion Criteria

• •Any untreated central nervous system (CNS) lesion
• •Uveal and mucosal melanoma
• •History of leptomeningeal metastases
• •History of or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or history of retinal degenerative disease
• •Any previous systemic chemotherapy treatment, extensive radiotherapy or investigational agent other than immunotherapy, or patients who have received more than one line of immunotherapy for locally advanced unresectable or metastatic melanoma; Ipilimumab (adjuvant) or other immunotherapy treatment must have ended at least 6 weeks prior to randomization
• •History of Gilbert's syndrome
• •Prior therapy with a BRAF inhibitor and/or a MEK- inhibitor
• •Impaired cardiovascular function or clinically significant cardiovascular diseases
• •Uncontrolled arterial hypertension despite medical treatment
• •HIV positive or active Hepatitis B, and/or active Hepatitis C
• •Impairment of gastrointestinal function
• •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