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Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer

NCT03785873 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-02-13

Study results available
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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.

Conditions

  • Biliary Tract Cancer

Interventions

DRUG

Nivolumab

Intravenous (IV) infusion

DRUG

Nanoliposomal-Irinotecan

Intravenous (IV) infusion

DRUG

5-Fluorouracil

Intravenous (IV) infusion

DRUG

Leucovorin

Intravenous (IV) infusion

Sponsors & Collaborators

  • Ipsen

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Vaibhav Sahai, MBBS, MS · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-22
Primary Completion
2024-11-15
Completion
2024-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03785873 on ClinicalTrials.gov