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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 is a Phase 1 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 34 participants.

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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.

Interventions

  • DRUG Leucovorin
  • DRUG Nivolumab
  • DRUG 5-Fluorouracil
  • DRUG Nanoliposomal-Irinotecan

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2019-05-22
Est. Completion 2024-11-15
Phase Phase 1

What the Registry Record Tells You About NCT03785873

The ClinicalTrials.gov registry entry for NCT03785873 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Leucovorin is the first listed.

NCT03785873 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.