Phase I Dose Escalation Trial of CP-675,206 (Tremelimumab, Anti-CTLA-4 Monoclonal Antibody) in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer
This is an open label, single-center Phase I study. All subjects will receive bicalutamide
150mg orally days 1-28. Subjects will receive CP-675,206 IV over one hour on day 29. Doses
will range from 6 mg/kg to 15 mg/kg. This cycle will be repeated once at month 3. Once the
maximum tolerated dose has been determined, up to 6 additional subjects will be enrolled.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The purpose of this research is to determine the safety of CP-675,206 when delivered in combination with short-term androgen deprivation therapy in patients with PSA-recurrent non-metastatic prostate cancer.
Up to 12 months after treatment with study agent
Douglas McNeel, MD, PhD
University of Wisconsin, Madison
United States: Food and Drug Administration
|University of Wisconsin Paul P. Carbone Comprehensive Cancer Center||Madison, Wisconsin 53792-6164|