drugset / Trial / NCT00075192
CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multi-center, open label, randomized study. Patients will be randomized to one of the following arms with an allocation ratio of 3:1, respectively: Arm A: CP-675,206 + neoadjuvant hormone therapy (NHT) OR Arm B: neoadjuvant hormone therapy. After randomization, patients will receive study treatment for three cycles (one cycle is defined as 28 days). After completion of three cycles, patients will undergo a prostatectomy and pathology assessments will be completed at a central laboratory, the Armed Forces Institute of Pathology (AFIP) in Washington, DC.
Timeline
- Start
- 2004-03
- Primary completion
- —
- Completion
- 2006-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tremelimumab | Monoclonal antibody | — | — |
| Background | Bicalutamide | Other / unclassified | — | — |
| Background | Leuprolide | Other / unclassified | — | — |