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

• Conditions: HLA-A*0201-Positive Patients with Previously Treated, Unresectable Stage III or IV Melanoma

• Registration Number: EUCTR2004-005059-32-BE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-01
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

Histological 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, fotomustine, 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; negative pregnancy testing; 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 (except adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast or bladder); primay ocular melanoma; active, untreated CNS metastasis; prior treatment with an anti-CTLA4 antibody; active autoimmune disease or a history of autoimmune disease except for vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism; pregnant or nursing; Hypersensitivity to Incomplete Freund's Adjuvant or component of the vaccine; any underlying condition which in the opinion of the investigator will make administration of the study drug hazardous or obscure the interpretation of adverse events; concomitant therapy with IL-2, interferon or other non-study anti-melanoma immunotherapy regimens or other investigational therapies, or chronic use of systemic corticosteroids.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified