At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 34 enrolled
Drug / intervention
Nivolumab +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Nivolumab, Nanoliposomal-Irinotecan, and 2 other interventions for Biliary Tract Cancer. Completed, enrolled 34 participants across 5 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiliary Tract Cancer
CountriesUnited States
CollaboratorsIpsen, Bristol-Myers Squibb
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartMay 2019
Primary CompletionNov 2024
TodayJul 2026
First PostedDec 24, 2018
Enrollment StartMay 22, 2019
Primary CompletionNov 15, 2024
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 7.5 years ago
Interventions
Nivolumabdrug
Intravenous (IV) infusion
Nanoliposomal-Irinotecandrug
Intravenous (IV) infusion
5-Fluorouracildrug
Intravenous (IV) infusion
Leucovorindrug
Intravenous (IV) infusion