An Open Label Study of MDX-CTLA4 in Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 in the Treatment of Patients With Resected Stage III or IV Melanoma
In the Phase I/II trial, patients with resected stages III and IV melanoma who have been
rendered free of disease, but are at high risk of relapse, are treated with peptides/IFA at
a dose of 0.5 mg each peptide plus CTLA-4 antibody given intravenously, 3 mg/kg, after each
vaccination. In the Phase II randomized study, patients are treated with the melanoma
peptide vaccine alone, with CTLA-4 antibody, or with CTLA-4 antibody combined with IL-12 at
30 ng/kg with alum. The peptides are tyrosinase 368-376 (370D); gp100 209-217 (210M); and
MART-1 26-35 (27L) which are emulsified with IFA. The dosing schedule for both trials are at
1, 2, 3, 4, 5, and 6 months; then at 9 and 12 for a total of 8 vaccinations.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Jeffrey S. Weber, M.D., Ph.D.
University of Southern California/Norris Cancer Center
United States: Food and Drug Administration
|Universtiy of Southern California/Kenneth Norris, Jr. Comprehensive Cancer Center||Los Angeles, California 90089|