A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination with a Melanoma Peptide Vaccine, and Melanoma Peptide Vaccine Monotherapy in HLA-A*0201-Positive Patients with Previously Treated Unresectable Stage III or IV Melanoma - Not Available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 750

Inclusion Criteria

Histologic diagnosis of malignant melanoma; Measureable unresectable Stage III or IV melanoma; at least 18 years of age; positive for HLA-A*0201; have demonstrated 1 of the following in response to at least 1 cycle of 1 or more regimens containing 1 or more of the following: IL-2, dacarbazine, temozolamide, fotemustine and/or carboplatin: 1) relapse following an objective response, 2) failed to demonstrate an objective response, or 3) inability to tolerate treatment due to unacceptable toxicity; at least 28 days since treatment with chemotherapy, biochemotherapy, surgery, radiation, or immunotherapy, and 14 days for gamma knife treatment and recovered from any clinically significant toxicity experienced during treatment; Women must meet 1 of the following criteria: post menopausal for at least 1 year; surgically incapable of bearing children, or utilizing a reliable form of contraception. Women of childbearing potential must have negative pregnancy tests; Men who may father a child must agree to the use of male contraception; Life expectancy greater than 4 months; ECOG of 0 or 1; meet required lab values; and negative HIV, HepB and HepC tests.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any other prior malignancy from which the patient has been disease free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or adequately treated carcinoma in situ of the cervix, breast or bladder; Primary ocular melanoma; Active, untreated CNS metastasis; Prior treatment with an anit-CTLA4 antibody; Prior treatment with any cancer therapeutic vaccine, including gp100 peptides; Active autoimmune disease or a history of autoimmune disease except for patients with vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism; Pregnant or nursing; Concomitant therapy with IL-2, interferon or other non-study anti-melanoma immunotherapy regimens, cytotoxic chemotherapy, immunosuppressive agents, or other investigational therapies, or chronic use of systemic corticosteroids; or the inability to provide adequate informed consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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