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NCT02428192 · ClinicalTrials.gov registry record · Phase 2
Nivolumab Alone or in Combination With Ipilimumab in Treating Patients With Advanced Uterine Leiomyosarcoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT02428192: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02428192 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02428192, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This phase II trial studies how well nivolumab alone or in combination with ipilimumab works in treating patients with uterine cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
For the primary endpoint of overall response with a null hypothesis of 5% and an alternative hypothesis of 20%, 37 patients are needed in a two-stage design with 12 patients in the first stage and 25 patients in the second stage. At the first stage analysis, overall response, at least 1 response out of 12 patients will need to be observed to continue through the second stage. At the second stage, at least 4 responses out of 37 patients will need to be observed to accept the treatment. The overal
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-05-19 |
| Est. Completion | 2021-01-28 |
| Phase | Phase 2 |
What the finished NCT02428192 record still lists
NCT02428192 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02428192 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02428192 about?
NCT02428192 is a clinical study titled "Nivolumab Alone or in Combination With Ipilimumab in Treating Patients With Advanced Uterine Leiomyosarcoma". This phase II trial studies how well nivolumab alone or in combination with ipilimumab works in treating patients with uterine cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Monoclonal antibodies, such as nivolumab and ipilimumab, may int...
What is the current status of trial NCT02428192?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2015-05-19. Estimated completion is 2021-01-28.
What interventions are being tested in trial NCT02428192?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02428192?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02428192's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 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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