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NCT02113657 · ClinicalTrials.gov registry record · Early Phase 1
T-Cell Responses to Neoantigens Post Treatment With Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer
A Early Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
NCT02113657: Completed Early Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT02113657 is a Early Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 30 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02113657, a Early Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to study the impact of ipilimumab on the immune system of patients currently receiving hormone therapy. The safety of these drug combinations will also be studied. This is an investigational study. Ipilimumab is FDA approved and commercially available for the treatment of melanoma. Its use to treat prostate cancer is investigational. Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Primary Outcome
T-cell response to neoantigens defined as: At least a 2-fold increase compared to the response seen against irrelevant control targets, and activating at least 0.1% of cells tested, or at least a 2-fold increase compared to baseline.
Interventions
- DRUG Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-08-20 |
| Est. Completion | 2019-11-04 |
| Phase | Early Phase 1 |
What the finished NCT02113657 record still lists
NCT02113657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which Ipilimumab is the first listed.
NCT02113657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02113657 about?
NCT02113657 is a clinical study titled "T-Cell Responses to Neoantigens Post Treatment With Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer". The goal of this clinical research study is to study the impact of ipilimumab on the immune system of patients currently receiving hormone therapy. The safety of these drug combinations will also be studied. This is an investigational study. Ipilimumab is FDA approved and commercially available for...
What is the current status of trial NCT02113657?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2014-08-20. Estimated completion is 2019-11-04.
What interventions are being tested in trial NCT02113657?
The interventions under investigation include: Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT02113657?
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 NCT02113657's enrollment target sits among peer trials
30 807th of 2000 higher than 1,075 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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