Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer
- Conditions
- Biliary Tract Cancer
- Interventions
- Registration Number
- NCT03785873
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nal-Irinotecan and Nivolumab Nanoliposomal-Irinotecan - Nal-Irinotecan and Nivolumab Nivolumab - Nal-Irinotecan and Nivolumab Leucovorin - Nal-Irinotecan and Nivolumab 5-Fluorouracil -
- Primary Outcome Measures
Name Time Method Phase II: Median Progression-Free Survival (PFS) Up to 2 years after last dose of study treatment or 3 years after first date of treatment initiation for those that remain on treatment Based on Kaplan-Meier estimates.
Phase Ib: Incidence of dose-limiting toxicities (DLTs) of drug combination nanoliposomal-Irinotecan, 5-fluorouracil, leucovorin and nivolumab At 4 weeks after initiation of study treatment Adverse events will be graded according to NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) Up to 2 years after last dose of study treatment Determined per the combined Response Evaluation Criteria in Solid Tumours (RECISTv1.1) and immune-related RECIST (irRECIST) criteria
Incidence of adverse events Until discontinuation of study treatment, up to approximately 2 years after initiating study treatment or 3 years after first date of treatment initiation for those that remain on treatment Reportable adverse events are defined by the study protocol and graded according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v5.0.
Median Overall Survival (OS) Up to 2 years after last dose of study treatment
Trial Locations
- Locations (5)
University of Michigan Rogel Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Cancer and Hematology Centers of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Virginia Mason
🇺🇸Seattle, Washington, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States