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NCT03785873 · ClinicalTrials.gov registry record · Phase 1
Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer
A Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT03785873: Completed Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
NCT03785873 is a Phase 1 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03785873, a Phase 1 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug combination of nivolumab plus nanoliposomal-irinotecan, 5-fluorouracil, and leucovorin for patients with advanced or metastatic biliary tract cancer after progression on first-line systemic therapy.
Primary Outcome
Adverse events will be graded according to NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.The patients accrued to the phase 2 portion of the trial were also observed for DLT during the first cycle of therapy given the same dose level was used.
Interventions
- DRUG Leucovorin
- DRUG Nivolumab
- DRUG 5-Fluorouracil
- DRUG Nanoliposomal-Irinotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-05-22 |
| Est. Completion | 2024-11-15 |
| Phase | Phase 1 |
What the finished NCT03785873 record still lists
NCT03785873 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 4 interventions - of which Leucovorin is the first listed.
NCT03785873 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03785873 about?
NCT03785873 is a clinical study titled "Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer". The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug combination of nivolumab plus nanoliposomal-irinotecan, 5-fluorouracil, and leucovorin for patients with advanced or metastatic biliary tract cancer after progressio...
What is the current status of trial NCT03785873?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2019-05-22. Estimated completion is 2024-11-15.
What interventions are being tested in trial NCT03785873?
The interventions under investigation include: Leucovorin (DRUG), Nivolumab (DRUG), 5-Fluorouracil (DRUG), Nanoliposomal-Irinotecan (DRUG).
Who is sponsoring clinical trial NCT03785873?
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 NCT03785873's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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