A Phase I, Open Label, Study To Evaluate The Safety And Immune Function Effects Of CP-675,206 In Combination With MART-1 Peptide-Pulsed Dendritic Cells In Patients With Advanced Melanoma
- Determine the safety and maximum tolerated dose of anti-cytotoxic
T-lymphocyte-associated antigen-4 monoclonal antibody (CTLA4-blocking monoclonal
antibody; CP-675,206) administered with autologous dendritic cells pulsed with MART-1
antigen in patients with unresectable stage III or stage IV melanoma.
- Determine the biological activity and immune effects of this regimen in these patients.
- Correlate CTLA4 genotype with safety of this regimen and/or immune response in these
- Determine, preliminarily, the efficacy of this regimen, in terms of clinical benefit
rate, in these patients.
OUTLINE: This is an open-label, dose-escalation study of anti-cytotoxic
T-lymphocyte-associated antigen-4 monoclonal antibody (CTLA4-blocking monoclonal antibody;
Patients receive CP-675,206 IV on days 0, 28, 60, and 90 and autologous dendritic cells
pulsed with MART-1 antigen intradermally on days 0, 14, and 28. After day 120, patients with
stable or responding disease may receive additional doses of CP-675,206 monthly in the
absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of CP-675,206 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 3-21 patients will be accrued for this study within 3-10
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
Antoni Ribas, MD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|