A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma

Inclusion Criteria

• •Participants with histologically confirmed melanoma, either unresectable stage IIIc or stage IV metastatic melanoma, as defined by the American Joint Committee on Cancer 7th edition. Unresectability of stage IIIc disease must have confirmation from a surgical oncologist
• •Participants must be naïve to treatment for locally advanced unresectable or metastatic disease (ie, no prior systemic anti-cancer therapy for advanced disease; stage IIIc and IV). Prior adjuvant immunotherapy (including ipilimumab) is allowed
• •Documentation of BRAF V600 mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples) using the cobas 4800 BRAF V600 mutation test
• •Measurable disease per RECIST v1.1
• •Eastern Clinical Oncology Group performance status of 0 or 1
• •Consent to provide archival for biomarker analyses
• •Consent to undergo tumor biopsies for biomarker analyses
• •Life expectancy greater than or equal to (≥) 12 weeks
• •Adequate hematologic and end organ function
• •1. All known CNS lesions have been treated with stereotactic therapy or surgery, AND
• •2. There has been no evidence of clinical and radiographic disease progression in the CNS for ≥ 3 weeks after radiotherapy or surgery
• •Current severe, uncontrolled systemic disease
• •History of malabsorption or other condition that would interfere with absorption of study drugs
• •Pregnant, lactating, or breast feeding women