Trial Information

Summary: Medarex MDX010-20: 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-A*0201-Positive Patients with Previously Treated Unresectable Stage III or IV Melanoma

You have been asked to participate in this research study because you have malignant melanoma that has spread to your lymph nodes or other location(s) and is not responding to standard treatment.  A blood test will be required to determine if you have the eligible tissue type, HLA-A2, which is present in about two out of five people.  The purpose of this study is to evaluate the effects on malignant melanoma of experimental treatment with MDX-010 (an antibody that stimulates the immune system) given with a Melanoma Peptide Vaccine as compared to MDX-010 given with a placebo as compared to Melanoma Peptide Vaccine given with a placebo.  Comparisons will be made in terms of tumor response (whether the tumor shrinks or stays the same), overall survival, side effects, and quality of life.  Your treatment in this study is expected to last 12 weeks.  You medical condition will be monitored for up to an additional 16 weeks for a total of 28 weeks.  After 28 weeks, your medical condition will be followed indefinitely, using standard information from your medical records.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: August 4, 2008 at 1:47:01 PM