Clinical trial · Interventional
CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CP-675,206 and leuprolide acetate and bicalutamide | Drug | — | UNRESOLVED |
| leuprolide acetate and bicalutamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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 outcomes (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available