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Combo Drug Therapy for Biliary Tract Cancer

Phase 1 & 2
Waitlist Available
Led By Vaibhav Sahai, MBBS, MS
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status of 0-1
Child-Pugh score of less than 7
Must not have
Must not have ongoing bowel obstruction.
Patients must not have uncontrolled intercurrent illness including, but not limited to, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 4 weeks after initiation of study treatment
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial will test a new combo drug for patients with biliary tract cancer that has progressed after first-line treatment.

Who is the study for?
This trial is for adults with advanced biliary tract cancer who've had one prior treatment but not with irinotecan or PD-1/PD-L1 inhibitors. They must have measurable disease, good liver function, and no major health issues like uncontrolled heart disease or active infections. People with certain drug sensitivities, untreated HIV/Hepatitis B/C, recent steroids use, brain metastasis, other cancers within a year or severe autoimmune diseases can't join.
What is being tested?
The study tests the combination of nivolumab (an immunotherapy) and nanoliposomal-irinotecan (a chemotherapy drug), along with 5-fluorouracil and leucovorin in patients whose biliary tract cancer has worsened after first-line therapy. It aims to assess how well this regimen works and its safety.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, diarrhea from irinotecan; plus typical chemo side effects like mouth sores and low blood counts from 5-fluorouracil/leucovorin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My liver function is relatively good.
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My cancer is in the bile ducts and cannot be removed or cured with surgery.
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I am 18 years old or older.
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I can safely undergo CT or MRI scans with contrast.
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I have a tumor that can be measured on scans and hasn't been treated with radiation or specific liver therapies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a current blockage in my intestines.
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I do not have any severe ongoing illnesses like serious lung disease or heart problems.
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I don't have Gilbert's syndrome or known UGT1A1* variants.
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I haven't taken steroids or immunosuppressants in the last 14 days, except for a short treatment.
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I do not have untreated or active HIV, Hepatitis B, or Hepatitis C.
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I am not allergic to 5-fluorouracil, leucovorin, irinotecan, or nivolumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 4 weeks after initiation of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4 weeks after initiation of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase II: Median Progression-Free Survival (PFS)
Phase Ib: Incidence of dose-limiting toxicities (DLTs) of drug combination nanoliposomal-Irinotecan, 5-fluorouracil, leucovorin and nivolumab
Secondary study objectives
Incidence of adverse events
Overall Response Rate (ORR)

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nal-Irinotecan and NivolumabExperimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Irinotecan
FDA approved
Fluorouracil
FDA approved
Leucovorin
FDA approved

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,696 Previous Clinical Trials
4,099,037 Total Patients Enrolled
University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
21,201 Total Patients Enrolled
IpsenIndustry Sponsor
352 Previous Clinical Trials
74,356 Total Patients Enrolled
Vaibhav Sahai, MBBS, MSPrincipal InvestigatorUniversity of Michigan
4 Previous Clinical Trials
185 Total Patients Enrolled

Media Library

Nivolumab Clinical Trial Eligibility Overview. Trial Name: NCT03785873 — Phase 1 & 2
Biliary Tract Cancer Research Study Groups: Nal-Irinotecan and Nivolumab
Biliary Tract Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03785873 — Phase 1 & 2
Nivolumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03785873 — Phase 1 & 2
~5 spots leftby Jan 2026
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