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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT03785873
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Intravenous (IV) infusion
  • Nanoliposomal-Irinotecan — DRUG
    Intravenous (IV) infusion
  • 5-Fluorouracil — DRUG
    Intravenous (IV) infusion
  • Leucovorin — DRUG
    Intravenous (IV) infusion

Study Details

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.

Key Dates

Start date
May 22, 2019
Status verified
Feb 2026
Primary completion
Nov 15, 2024
Completion
Nov 15, 2024

Study Design

Enrollment
34 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nal-Irinotecan and Nivolumab

Primary Outcome Measure

Phase Ib: Incidence of Dose-limiting Toxicities (DLTs) of Drug Combination Nanoliposomal-Irinotecan, 5-fluorouracil, Leucovorin and Nivolumab [ Time Frame: At 4 weeks after initiation of study treatment ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-
Cancer and Hematology Centers of Western MichiganGrand RapidsMichigan49503-
University of UtahSalt Lake CityUtah84132-
Virginia MasonSeattleWashington98101-
University of WisconsinMadisonWisconsin53705-

Related coverage on Hipa.ai

Find similar trials in Ann Arbor, MI

By research site
University of Michigan Rogel Cancer Center· Ann Arbor, MICancer and Hematology Centers of Western Michigan· Grand Rapids, MIUniversity of Utah· Salt Lake City, UTVirginia Mason· Seattle, WAUniversity of Wisconsin· Madison, WI

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