drugset / Trial / NCT03785873
Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer
Phase 1/2
Completed
34 enrolled
University of Michigan Rogel Cancer Center
Bristol-Myers Squibb · collabIpsen · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-05-22
- Primary completion
- 2024-11-15
- Completion
- 2024-11-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 70 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |