Melanoma

This open-label, single-arm, multicenter study will evaluate the efficacy and safety in patients with metastatic melanoma who developed brain metastases. Patients may or may not have received prior treatment for metastatic melanoma with brain metastases (except treatment with BRAF or MEK inhibitors). Patients will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.

• Adult patients, >/= 18 years of age
• Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF V600 mutation (cobas 4800 BRAF V600 Mutation Test)
• Measurable brain metastases, treated or untreated
• Patients may or may not have received prior systemic therapy for metastatic melanoma and either a) have received no prior treatment for brain metastases or b) have received prior treatment for brain metastases and have progressed
• Patients may or may not have symptoms related to their brain metastases
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma

• Increasing corticosteroid dose during the 7 days prior to first dose of study drug
• Leptomeningeal involvement
• Previous malignancy requiring active treatment within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix
• Concurrent administration of any anticancer therapies other than those administered in the study
• Treatment with any cytotoxic, investigational drug or targeted therapy 4 weeks prior to first dose of study drug. Radiation therapy 2 weeks prior to first dose of study drug
• Prior treatment with BRAF or MEK inhibitors
• Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug