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-GB
- Lead Sponsor
- Medarex, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 750
Histologic diagnosis of malignant melanoma; Measureable 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 24 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; negative pregnancy test; life expectancy 4 months or greater; 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
Any other prior malignancy for 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; prior treatment with any cancer vaccine; active, untreated CNS metastasis; prior treatment with an anti-CTLA4 antibody; any 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 or other investigational therapies, or chronic use of systemic corticosteroids; any underlying medical condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea.
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