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