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

• Status: Completed
• Trial end date: 2015-05-12
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Ipilimumab; Vemurafenib

Criteria

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