CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Open Label, Non-Randomized, Dose Escalation Study to Evaluate the Safety of CP-675,206 in Combination With Neoadjuvant Androgen Ablation and a Phase 2, Open Label, Randomized Study to Evaluate the Efficacy of CP-675,206 in Combination With Neoadjuvant Androgen Ablation and Androgen Ablation Alone in Patients With High Risk Prostate Cancer

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: CP-675,206 and leuprolide acetate and bicalutamide
* Drug: leuprolide acetate and bicalutamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate, previously untreated Potential candidate for radical prostatectomy on the basis of the patient's general medical condition, performance status, and life expectancy Potential candidate for NHT prior to prostatectomy, including high or intermediate risk of recurrence, based on an estimated risk of biochemical recurrence: High risk category: PSA >20 or Gleason score 8 or cT2c/cT3 OR Intermediate risk category: PSA >10 and d20 or Gleason score 7 or cT2b No evidence of metastatic disease by physical examination, bone scan, and computed tomography, or MRI, of the abdomen and pelvis Age > 18 years ECOG performance status 0-1 Adequate bone marrow, hepatic, and renal function determined within 2 weeks prior to starting therapy Availability of prostatectomy specimen for histological analysis at the Armed Forces Institute of Pathology Exclusion Criteria: Prior hormone therapy, radiation, chemotherapy, or immunologic therapy for prostate cancer History of, or significant risk for, chronic inflammatory or autoimmune disease Potential requirement for systemic corticosteroids before surgery based on prior history History of autoimmune colitis or chronic GI conditions associated with diarrhea or bleeding, or current acute colitis of any origin Any serious uncontrolled medical disorder or active infection which would impair ability to receive study treatment and subsequent prostatectomy Coexisting malignancies except basal or squamous cell carcinoma of the skin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CP-675,206 and leuprolide acetate and bicalutamide|nan|
|Drug: leuprolide acetate and bicalutamide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  |