MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response [PR/CR]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Diagnosed with malignant melanoma

• Measurable unresectable Stage III or IV melanoma

• HLA-A*0201 positive

• Previous treatment with & failure/relapse/inability to tolerate IL-2, dacarbazine and/or temozolomide

• At least 4 weeks since prior treatment

• Negative pregnancy

• Life expectancy greater than 4 months

• Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1

• Required lab values

• Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) negative

Exclusion Criteria:

• Prior malignancies which the patient has not been disease free for over 5 years, except treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or any other cancer

• Ocular melanoma

• Active, untreated central nervous system (CNS) metastasis

• Prior treatment with MDX-010 (anti-CTLA4) antibody

• Prior treatment with any cancer therapeutic vaccine

• Active autoimmune disease or history of autoimmune disease

• Pregnancy or nursing

• Hypersensitivity to Incomplete Freund's Adjuvant (IFA) (Montanide ISA-51)

• Underlying medical conditions deemed hazardous if treated with study drug

• Concomitant therapy with anti-melanoma drugs, chemotherapies, other investigational therapies, chronic use of systemic corticosteroids

• Unable to provide informed consent