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NCT03639935 · ClinicalTrials.gov registry record · Phase 2
Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT03639935: Completed Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT03639935 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03639935, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
Investigators hypothesize that following first-line platinum based chemotherapy, rucaparib in combination with nivolumab, will improve progression-free survival and overall survival in BTC patients.
Primary Outcome
Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions (with a minimum absolute increase of 5 mm), taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. A clinical decision of progression by the site investigator will be based on the subject's overall clinical condition, including performance status, clinical symptoms, and laboratory data.
Interventions
- DRUG Nivolumab
- DRUG Rucaparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2019-03-28 |
| Est. Completion | 2024-04-30 |
| Phase | Phase 2 |
What the finished NCT03639935 record still lists
NCT03639935 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT03639935 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03639935 about?
NCT03639935 is a clinical study titled "Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy". Investigators hypothesize that following first-line platinum based chemotherapy, rucaparib in combination with nivolumab, will improve progression-free survival and overall survival in BTC patients.
What is the current status of trial NCT03639935?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2019-03-28. Estimated completion is 2024-04-30.
What interventions are being tested in trial NCT03639935?
The interventions under investigation include: Nivolumab (DRUG), Rucaparib (DRUG).
Who is sponsoring clinical trial NCT03639935?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03639935's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 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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