Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma

Exclusion Criteria

• •Primary ocular melanoma
• •Active brain metastases with symptoms or requiring corticosteroid treatment
• •Any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
• •History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies
• •History of or current immunodeficiency disease, splenectomy, or splenic irradiation
• •Prior anticancer therapy or investigational products \<4 weeks prior to enrollment
• •Prior therapy with a BRAF or MEK inhibitor and prior investigational anticancer immunotherapies;
• •Prior therapies with immunosuppressive agents within the past 2 years
• •Concomitant therapy with any anticancer or potent immunosuppressive agent, surgery, radiotherapy, other investigational anticancer therapies, or chronic use of systemic corticosteroids