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

A Single Arm Open-Label Phase II Study of Vemurafenib Followed by Ipilimumab in Subjects With Previously Untreated V600 BRAF Mutated Advanced Melanoma

The purpose of this study is to assess the safety profile of vemurafenib, 960 mg, administered for 6 weeks, followed by ipilimumab monotherapy in patients with BRAF V600 mutated advanced/metastatic melanoma.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Key Inclusion Criteria:

• Men and women 18 years of age and older
• Histologic diagnosis of malignant melanoma tested positive for the BRAF V600 mutation
• Previously untreated unresectable Stage III or Stage IV melanoma
• Complete set of brain/neck, chest, abdomen/pelvis axial radiographs taken within 28 days of first dose of study drug
• Measurable melanoma by physical or radiographic examination
• Brain metastases stable after radiation for at least 1 month and off corticosteroid therapy for ≥30 days prior to enrollment
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Adequate hematologic parameters and renal and hepatic function

Key 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