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NCT01194271 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Ipilimumab in Prostate Cancer
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT01194271: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01194271 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01194271, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn how ipilimumab in combination with Lupron (leuprolide acetate) affects the body's own defense (immune) system before having surgery to remove prostate cancer. The safety of the drug combination will also be studied.
Primary Outcome
Immunological response assays were measured at several time points starting at baseline until the eighth week after starting the medicine for each participant. The immunological responses measured were Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Inducible T-cell Costimulatory (ICOS) markers. T-cells with the CD4 marker help coordinate the immune system response to an invader. Killer T-cells have the CD8 marker and are responsible for killing the invader. ICOS is a
Interventions
- DRUG Ipilimumab
- PROCEDURE Radical Prostatectomy
- DRUG Leuprolide Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2010-09 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
What the finished NCT01194271 record still lists
NCT01194271 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 3 interventions - of which Ipilimumab is the first listed.
NCT01194271 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01194271 about?
NCT01194271 is a clinical study titled "Neoadjuvant Ipilimumab in Prostate Cancer". The goal of this clinical research study is to learn how ipilimumab in combination with Lupron (leuprolide acetate) affects the body's own defense (immune) system before having surgery to remove prostate cancer. The safety of the drug combination will also be studied.
What is the current status of trial NCT01194271?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2010-09. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01194271?
The interventions under investigation include: Ipilimumab (DRUG), Radical Prostatectomy (PROCEDURE), Leuprolide Acetate (DRUG).
Who is sponsoring clinical trial NCT01194271?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01194271's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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