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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-675,206 and leuprolide acetate and bicalutamide | Drug | |||
| leuprolide acetate and bicalutamide | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Assess safety of combination therapy and effectiveness as assessed by pathological response after 3 months of treatment follow for disease status for a maximum of 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| assess Pk during treatment monitor for human anti-human antibodies at the end of the study explore genetic influences on safety and/or immune response |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | La Masa | California | 91442 | United States | ||
| Research Site |
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| Washington D.C. |
| District of Columbia |
| 20307 |
| United States |
| Research Site | Gallatin | Tennessee | 37066 | United States |
| Research Site | Hermitage | Tennessee | 37076 | United States |
| Research Site | Lebanon | Tennessee | 37087 | United States |
| Research Site | Murfreesboro | Tennessee | 37130 | United States |
| Research Site | Nashville | Tennessee | 37203 | United States |
| Research Site | Nashville | Tennessee | 37205 | United States |
| Research Site | Nashville | Tennessee | 37207 | United States |
| Research Site | Nashville | Tennessee | 37211 | United States |
| Research Site | Smyrna | Tennessee | 37167 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C520704 | tremelimumab |
| D016729 | Leuprolide |
| C053541 | bicalutamide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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