Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
Futibatinib + Pembrolizumab for Liver Cancer
Phase 2
Recruiting
Led By Nguyen H. Tran, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Tumor tissue must be FGF19 positive by messenger ribonucleic acid (mRNA) or immunohistochemistry (IHC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying the effect of futibatinib and pembrolizumab in treating patients with liver cancer that has spread to other parts of the body and has a positive FGF19 marker.
Who is the study for?
Adults with advanced or metastatic liver cancer that tests positive for FGF19 and have already tried one systemic treatment. They must be able to take oral meds, provide consent, complete questionnaires, use contraception effectively, and meet specific health criteria like adequate blood counts and liver function.Check my eligibility
What is being tested?
The trial is testing the combination of futibatinib (a drug blocking enzymes for cell growth) with pembrolizumab (an immunotherapy antibody). It aims to see if this combo can better attack cancer cells in patients with a particular type of liver cancer.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, fatigue, skin issues, changes in hormone levels affecting different body functions, and potential infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My tumor is FGF19 positive.
Select...
I have had at least one treatment for liver cancer.
Select...
My liver cancer is at an early to intermediate stage.
Select...
I have at least one tumor that can be measured and hasn't been treated with radiation or targeted liver therapy.
Select...
My liver cancer cannot be treated with surgery, transplant, or targeted therapies.
Select...
My liver cancer diagnosis was confirmed through imaging or biopsy.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My liver function is relatively good.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Change in quality of life (QOL)
Incidence of adverse events
Overall response rate (ORR)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (futibatinib, pembrolizumab)Experimental Treatment3 Interventions
Patients receive futibatinib PO QD on days 1-21 for cycles 1-9, and days 1-42 for subsequent cycles and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for cycles 1-9 and every 42 days for subsequent cycles for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Futibatinib
2014
Completed Phase 2
~410
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,213 Previous Clinical Trials
3,766,986 Total Patients Enrolled
4 Trials studying Liver Cancer
9,361 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,980 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Nguyen H. Tran, M.D.Principal InvestigatorMayo Clinic in Rochester
2 Previous Clinical Trials
1,250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently receiving any experimental treatment for your cancer.I have HIV with a detectable viral load and low CD4 count, and I'm not on treatment.I am 18 years old or older.My tumor is FGF19 positive.I have had at least one treatment for liver cancer.My liver cancer is at an early to intermediate stage.I cannot stop taking certain strong medications for at least 7 days before joining.I have significant health issues related to calcium or phosphorus levels, or unusual mineral deposits in my body.I have at least one tumor that can be measured and hasn't been treated with radiation or targeted liver therapy.My blood clotting tests are normal or within the target range if I'm on blood thinners.I have not had lung inflammation or disease in the last 3 years.My liver cancer cannot be treated with surgery, transplant, or targeted therapies.My cancer has spread to my brain or its coverings.I do not have serious or unmanaged heart conditions.My kidney function, measured by creatinine clearance, is adequate.I do not have any severe infections or mental health issues that would prevent me from following the study's requirements.My liver cancer diagnosis was confirmed through imaging or biopsy.I have not had any other cancer within the last 6 months.I can take care of myself and am up and about more than half of my waking hours.I have a significant eye disorder confirmed by an eye exam.I have hepatitis B with a viral load of 100 IU/ml or more.I can take pills by mouth.My liver function is relatively good.My liver enzymes are within the required range for the study.There is a known treatment that could cure or extend my life.I can attend all appointments and follow the study plan.You have a history of or are at risk for autoimmune disease.I have had an organ transplant.You are currently pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (futibatinib, pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is this medical trial presently enrolling participants?
"Information hosted on clinicaltrials.gov reveals that this medical trial is actively seeking volunteers, with the original posting being made on May 7th 2021 and its most recent editing having occurred on November 9th 2022."
Answered by AI
To what degree are patients put at risk when taking Futibatinib?
"Preceding clinical data suggests that futibatinib is a safe drug, thus earning it a rating of 2 on our internal safety scale. However, there has yet to be any evidence supporting its efficacy in this phase 2 trial."
Answered by AI
What disorders typically respond to Futibatinib treatment?
"Futibatinib has been found to be effective in treating malignant tumors, unresectable melanomas, and cases of microsatellite instability high."
Answered by AI
What is the total population of participants enrolled in this research project?
"Affirmative. Clinicaltrials.gov discloses that this clinical trial, which was first posted on May 7th 2021, is actively recruiting participants. Approximately 25 people need to be recruited from 1 medical centre."
Answered by AI
Could you provide a synopsis of prior studies that have explored Futibatinib's efficacy?
"At present, there are 966 ongoing studies pertaining to Futibatinib with 124 of them in the concluding stage. Primarily based out of Houston, Texas, 35969 sites across the globe have been allocated for clinical trials involving this therapy."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger