NCT03785873

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

A Single Arm Phase Ib/II Multi-Center Study of Nivolumab in Combination With Nanoliposomal-Irinotecan, 5-Fluorouracil, and Leucovorin as Second Line Therapy for Patients With Advanced Biliary Tract Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Nivolumab	Intravenous (IV) infusion
DRUG	Nanoliposomal-Irinotecan	Intravenous (IV) infusion
DRUG	5-Fluorouracil	Intravenous (IV) infusion
DRUG	Leucovorin	Intravenous (IV) infusion

Timeline

• Start date: 2019-05-22
• Primary completion: 2024-11-15
• Completion: 2024-11-15
• First posted: 2018-12-24
• Last updated: 2026-02-13
• Results posted: 2026-02-13

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study