Clinical trial · Interventional
Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer
Phase 1 Study of Sipuleucel-T and Ipilimumab in Combination for Advanced Prostate Cancer
NCT01832870CI-TRIAL-00029257completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 clinical trial designed to quantify the immune response and determine the tolerability and side effects of sipuleucel-T when given in combination with ipilimumab for patients with advanced prostate cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castrate Resistant Prostate Cancer | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ipilimumab | Drug | Ipilimumab | ALIAS |
| sipuleucel-T | Drug | Autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Patients enrolled will receive the standard 3-dose treatment of sipuleucel-T, followed by treatment(s) of ipilimumab.
- interventionNames
- Drug: sipuleucel-T
- Drug: ipilimumab
Primary outcomes (3)
- measure
- Antigen-specific memory T cell response
- timeFrame
- After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months
- description
- To quantify antigen-specific memory T cell response to sipuleucel-T and ipilimumab in combination.
- measure
- Antigen-specific T cell proliferation to PA2024, PAP and PHA
- timeFrame
- After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with advanced prostate cancer who are eligible to receive sipuleucel-T in accordance with FDA approved labeling of sipuleucel-T * Subjects must understand and sign an informed consent form Exclusion Criteria: * Subjects who are not eligible to receive sipuleucel-T
References
Publications (0)
Data not yet available
No reference posted for this study.