Clinical trial · Interventional
CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrollment was halted prematurely due to slow accrual.
Summary
Brief summary (as posted)
The current protocol will evaluate the safety of combining treatment with bicalutamide(Casodex) and CP-675,206 (anti-CTLA-4 monoclonal antibody) in patients with PSA-recurrent non-metastatic (stage D0) prostate cancer. This is a dose escalation study with safety the primary endpoint. Secondary endpoints will be to determine whether prostate associated immune responses are seen, and whether treatment is associated with an increase in PSA doubling time and PSA recurrence at one year, as markers of clinical activity. Cohorts of six patients will be treated in each dose level. The investigators hypothesize that short-term androgen deprivation therapy will elicit prostate cancer-associated T-cell mediated tissue destruction that can be augmented with a monoclonal antibody blocking CTLA-4, and that this will have therapeutic benefit in patients with recurrent prostate cancer.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bicalutamide and CP-675,206 (Tremelimumab) | Drug | — | UNRESOLVED |
| Bicalutamide, CP-675,206 | Drug | — | UNRESOLVED |
| Bicalutamide, CP-675,206 (tremelimumab) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
- interventionNames
- Drug: Bicalutamide and CP-675,206 (Tremelimumab)
- Drug: Bicalutamide, CP-675,206 (tremelimumab)
- Drug: Bicalutamide, CP-675,206
Primary outcomes (1)
- measure
- The Number of Participants Who Developed Cancer Antigen-specific Immune Responses
- timeFrame
- Up to 12 months after treatment with study agent
Secondary outcomes (2)
- measure
- The Number of Participants With an Increase in PSA Doubling Time
- timeFrame
- Up to 18 months after last dose of study agent
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years of age \& histologic diagnosis of adenocarcinoma of the prostate * Completed surgery or radiation at least 8 weeks prior to entry with removal of all visible disease * Clinical Stage D0 prostate cancer with rising PSA and PSA \>2ng/ml. * ECOG performance of \<2 * Normal hematologic, renal and liver function Exclusion Criteria: * Cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy. * No prior treatment with an LHRH agonist or nonsteroidal antiandrogen such as casodex or flutamide * No evidence for metastatic disease per bone scan or CT scan of the abdomen and pelvis * No prior treatment with anti-CTLA 4 monoclonal antibody * No history of known autoimmune disorder or HIV, hepatitis B or hepatitis C * No known brain metastases * No history of inflammatory bowel conditions including diverticulitis, ulcerative colitis, etc.
References
Publications (0)
Data not yet available