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NCT03631641 · ClinicalTrials.gov registry record · Phase 2
Nivolumab in Preventing Colon Adenomas in Participants With Lynch Syndrome and a History of Partial Colectomy
A Phase 2 study, sponsored by John Hays.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT03631641: Clinical Trial Phase 2 study, sponsored by John Hays.
NCT03631641 is a Phase 2 study that was terminated before completion, run by John Hays. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03631641, a Phase 2 study, was terminated before completion, sponsored by John Hays.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
This phase II trial studies how well nivolumab works in preventing colon adenomas in participants with Lynch syndrome and a history of surgery to remove part of the colon. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
The associated confidence intervals will be reported and used to determine if the incidence rate is significantly different from that reported among Lynch patients not receiving nivolumab, 0.33.
Interventions
- BIOLOGICAL Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2018-10-04 |
| Est. Completion | 2021-01-25 |
| Phase | Phase 2 |
Why NCT03631641 stopped before completion
NCT03631641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Nivolumab is the first listed.
NCT03631641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03631641 about?
NCT03631641 is a clinical study titled "Nivolumab in Preventing Colon Adenomas in Participants With Lynch Syndrome and a History of Partial Colectomy". This phase II trial studies how well nivolumab works in preventing colon adenomas in participants with Lynch syndrome and a history of surgery to remove part of the colon. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread.
What is the current status of trial NCT03631641?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2018-10-04. Estimated completion is 2021-01-25.
What interventions are being tested in trial NCT03631641?
The interventions under investigation include: Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03631641?
This trial is sponsored by John Hays, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03631641's enrollment target sits among peer trials
3 2001st of 2000 the lowest 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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