Trial Information

Summary: Phase III: A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination with a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2 0201-Positive Patients with Previously Treated Unresectable Stage III or IV Melanoma

Purpose: The purpose of this study is to determine the safety and efficacy of MDX-010 (anti-CTLA4) in combination with MDX-1379 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 IL-2, dacarbazine, and/or temozolomide, have 1) relapsed following an objective 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.

Inclusion Criteria:

• Diagnosed with malignant melanoma
• Measurable unresectable Stage III or IV melanoma
• At least 18 years old
• 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
• ECOG performance of 0 or 1
• Required lab values
• HIV, HBV, HCV negative

Exclusion Criteria:

• Prior malignancies which the patient has not been disease free for 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 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

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.