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Sponsored by: |
Medarex |
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Information provided by: | Medarex |
ClinicalTrials.gov Identifier: | NCT00094653 |
The purpose of this study is to determine the safety and efficacy of MDX-010 (anti-CTLA4) in combination with MDX-1379 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 IL-2, dacarbazine, and/or temozolomide, have 1) relapsed following an objective 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.
Condition | Intervention | Phase |
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Melanoma Metastases |
Drug: MDX-010 (anti-CTLA4) monoclonal antibody Biological: MDX-1379 Melanoma Peptide Vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 750 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Melanoma Peptide Vaccine (MDX-1379) + Placebo
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Biological: MDX-1379 Melanoma Peptide Vaccine
2mL (2 subcutaneous injections of 1mL each, to each thigh), every 3 weeks for 4 doses.
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2: Experimental
MDX-010 + MDX-1379 (Melanoma Peptide Vaccine)
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Drug: MDX-010 (anti-CTLA4) monoclonal antibody
3mg/kg (iv infusion over 90 minutes), every 3 weeks for 4 doses
Biological: MDX-1379 Melanoma Peptide Vaccine
2mL (2 subcutaneous injections of 1mL each, to each thigh), every 3 weeks for 4 doses.
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3: Active Comparator
MDX-010 + Placebo
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Drug: MDX-010 (anti-CTLA4) monoclonal antibody
3mg/kg (iv infusion over 90 minutes), every 3 weeks for 4 doses
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Michael Yellin, MD | Medarex |
Responsible Party: | Medarex, Inc. ( Michael Yellin, Senior Director, Clinical Science ) |
Study ID Numbers: | MDX010-20 |
Study First Received: | October 21, 2004 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00094653 |
Health Authority: | United States: Food and Drug Administration |
melanoma metastatic melanoma skin cancer |
Skin Neoplasms Cytotoxic T-lymphocyte antigen 4 Melanoma Neuroendocrine Tumors Antibodies, Monoclonal Neuroectodermal Tumors Antibodies |
Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neoplasm Metastasis Neuroepithelioma Nevus Immunoglobulins |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Histologic Type Immunologic Factors |
Physiological Effects of Drugs Neoplasms, Nerve Tissue Nevi and Melanomas Pharmacologic Actions |