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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 4 weeks after initiation of study treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 4 weeks after initiation of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 4 weeks after initiation of study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Incidence of adverse events
Median Overall Survival (OS)
Overall Response Rate (ORR)
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
Fluorouracil
FDA approved
Leucovorin
FDA approved
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,480 Total Patients Enrolled
University of Michigan Rogel Cancer CenterLead Sponsor
293 Previous Clinical Trials
24,063 Total Patients Enrolled
IpsenIndustry Sponsor
345 Previous Clinical Trials
73,194 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have another active cancer except for non-dangerous skin cancer or treated cervical cancer.I have not had an organ transplant or untreated brain cancer spread.I've had one treatment for my advanced disease, but not with irinotecan or PD-1/PD-L1 inhibitors.I do not have a current blockage in my intestines.I am fully active or can carry out light work.I do not have any severe ongoing illnesses like serious lung disease or heart problems.My liver function is relatively good.My cancer is in the bile ducts and cannot be removed or cured with surgery.I am 18 years old or older.I don't have Gilbert's syndrome or known UGT1A1* variants.I haven't taken steroids or immunosuppressants in the last 14 days, except for a short treatment.I have not had major surgery in the last 4 weeks.I haven't had a fever or needed antibiotics for more than 48 hours.I had cancer treatment over 4 weeks ago and have mostly recovered.I do not have an autoimmune disease that affects my organs or requires systemic treatment, except for allowed conditions.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.My organs are working well, as checked within the last 2 weeks.I agree to use two forms of birth control or abstain from sex during and after the study.I have tissue samples from a previous biopsy or surgery available.I have not had a live vaccine in the last 30 days.I am not pregnant or breastfeeding and, if capable of bearing children, have tested negative for pregnancy.I can safely undergo CT or MRI scans with contrast.I have a tumor that can be measured on scans and hasn't been treated with radiation or specific liver therapies.I am not taking warfarin, certain seizure medications, antibiotics, antifungals, or specific HIV medications.I don't have a condition that causes severe diarrhea or could worsen by joining this study.I do not have untreated or active HIV, Hepatitis B, or Hepatitis C.I am not allergic to 5-fluorouracil, leucovorin, irinotecan, or nivolumab.
Research Study Groups:
This trial has the following groups:- Group 1: Nal-Irinotecan and Nivolumab
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent has Nivolumab been shown to be effective in treating patients?
"Nivolumab is a common treatment for malignant neoplasms. Additionally, it can be used to treat other solid tumours including unresectable melanoma, squamous cell carcinoma, and rectal carcinoma."
Answered by AI
Is this research looking for new participants at the moment?
"This clinical trial, as reported on clinicaltrials.gov, is not actively recruiting patients at this time. The study was originally posted on 5/22/2019 and was most recently updated on 10/6/2022. Although this study is not looking for participants right now, there are 1358 other clinical trials that are currently recruiting patients."
Answered by AI
What is the highest number of people who are allowed to participate in this experiment?
"Unfortunately, this particular study is no longer enrolling new patients. The listing for the clinical trial was first created on May 22nd, 2019 and edited for the last time on October 6th, 2020. If you are looking for other opportunities, there are presently 105 trials actively searching for participants with biliary tract cancer and 1253 studies for Nivolumab that are still recruiting patients."
Answered by AI
What other similar research has been conducted using Nivolumab?
"At the present moment, there are 1253 ongoing studies related to Nivolumab with 224 of them being in Phase 3. The majority of these clinical trials for Nivolumab originate from Shanghai, China; however, there are 64517 locations around the world where research is being conducted."
Answered by AI
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