An Extended Dosing, Two-phase Study of MDX-010 as Monotherapy or in Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 VG in the Treatment of Subjects With Resected Stage III or Stage IV Melanoma
OBJECTIVES:
Primary
- Achieve at least a 40% autoimmune breakthrough event rate, as defined by the induction
of grade 1, grade 2, or acceptable grade 3 drug-related autoimmune adverse events, in
patients with resected stage III or IV melanoma treated with anti-cytotoxic
T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) and peptide vaccine
comprising tyrosinase, gp100 antigen, and MART-1 antigen emulsified in Montanide
ISA-51.
Secondary
- Determine the incidence of drug-related autoimmune adverse events of any grade in
patients treated with this regimen.
- Determine the time to disease relapse in patients treated with this regimen.
- Determine the immunologic response in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
(MDX-010) IV over 90 minutes on day 1 of weeks 1, 9, 17, 25, 33, 41, and 53 and peptide
vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen emulsified in Montanide
ISA-51 subcutaneously on day 1 of weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
First part of study: To achieve at least a 40% immune-related adverse event rate defined by the induction of Grade 1, grade 2, or acceptable grade 3 drug-related immune-related adverse events
Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, 47, 53, then every 3 months for up to two additional years
Yes
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
CDR0000365467
NCT00084656
May 2004
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |