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
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
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.
Melanoma accounts for approximately 5% of all skin cancers in the United States, but it accounts for about 75% of all skin cancer deaths. In 2004, the expected prevalence of melanoma is 627,252, with about 119,178 of these cases being Stage III or IV (metastatic melanoma). First line treatments for metastatic melanoma, usually IL-2, dacarbazine and/or temozolomide, are associated with significant toxicities. MDX-010 (anti-CTLA4) antibodies are designed to keep the immune system running by blocking CTLA-4 from down-regulating T cell activation. MDX-1379 is made up of two peptides that are pieces of a bigger melanoma protein (gp100). These peptides bind to HLA-A2 which is then recognized by T cells.
Inclusion Criteria:
Exclusion Criteria:
San Francisco, California 94109, United States
New Haven, Connecticut 06520, United States
Lutherville, Maryland 21093, United States
Hackensack, New Jersey 07601, United States
New York, New York 10032, United States
Ciudad de Buenos Aires, Buenos Aires, Argentina
Ciudad de Buenos Aires, C1280AEB, Argentina
Ciudad de Buenos Aires, C1405BWU, Argentina
Ciudad de Buenos Aires, C1405DCS, Argentina
Ciudad de Buenos Aires, C1417DTB, Argentina
Ciudad de Buenos Aires, C1426BOS, Argentina
Ciudad de Buenos Aires, C1426DRB, Argentina
Barretos - SP, 14784-400, Brazil
Belo Horizonte - MG, 34000-000, Brazil
Goiania - GO, 74605-070, Brazil
Londrina - PR, 86050-190, Brazil
Porto Alegre, 90035-003, Brazil
Porto Alegre - RS, 90035-003, Brazil
Porto Alegre - RS, 90610-000, Brazil
Santo Andre-SP, 09090-780, Brazil
Sao Paulo - SP, 05403-000, Brazil
Sao Paulo-SP, 01308-050, Brazil
Hufelandstr. 55, Hesse 45122, Germany