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-HU
- Lead Sponsor
- Medarex, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1051
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 a first-line treatment with a single regimen containing IL-2, dacarbazine, and/or temozolamide: 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 4 weeks since treatment; 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
Any other prior malignancy (except cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix); ocular melanoma; active, untreated CNS metastasis; prior treatment with the IMPs; prior treatment with any active autoimmune disease or a history of autoimmune disease except for patients with vitiligo; 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the safety and efficacy, measured as best objective response rate (BORR), of MDX-010 when administered in combination with a gp100 melanoma peptide vaccine and to demonstrate the independent contributions of the vaccine and MDX-010 when given to patients with unresectable Stage III or IV melanoma who have been previously treated with other agents.;Secondary Objective: Evaluation of the overall survival, determination of major durable response rate, duration of response, progression-free survival, time-to progression, and health-related Quality of Life.;Primary end point(s): Primary Efficacy Endpoint: Best overall response rate (BORR) as determined by central adjudication up to Week 24.
- Secondary Outcome Measures
Name Time Method