A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (RO5185426) Adjuvant Therapy in Patients With Surgically Resected, Cutaneous BRAF Mutant Melanoma at High Risk for Recurrence

Inclusion Criteria:

- Patients with completely resected, histologically confirmed, Stage IIC or Stage III,
cutaneous melanoma where the BRAFV600 mutation status of the current primary tumor or
involved lymph node is determined to be positive using the cobas® BRAF V600 Mutation
Test. Patients with Stage IIIA disease must have at least one lymph node metastasis
measuring > 1 mm in diameter

- Patients must have been surgically rendered free of disease within 70 days of
randomization

- Eastern Cooperative Oncology Group performance status of 0 or 1

- Life expectancy of at least 5 years

- Patients must have fully recovered from the effects of any major surgery or
significant traumatic injury prior to the first dose of study treatment

- Adequate hematologic, hepatic and renal function

Exclusion Criteria:

- History of any systemic therapy for the treatment of melanoma

- History of limb perfusion therapy

- History of radiotherapy for the treatment of melanoma

- Invasive malignancy other than melanoma at the time of enrollment or within 3 years
prior to first dose of study treatment

- Family history of colon cancer syndromes

- History of clinically significant cardiac or pulmonary dysfunction

- Major surgical procedure within 4 weeks prior to first dose of study treatment

- Infection with human immunodeficiency virus, hepatitis B or hepatitis C virus