What side effects are associated with this type of intervention?

Common treatments for liver cancer, such as enzyme inhibitors like futibatinib and immune checkpoint inhibitors like pembrolizumab, have distinct side effect profiles. Futibatinib may cause increased levels of liver enzymes (transaminases) and creatine phosphokinase, indicating potential liver and muscle damage. Pembrolizumab can lead to immune-related adverse events, including hepatotoxicity, fatigue, and diarrhea. These side effects reflect the mechanisms of action of these drugs, with futibatinib targeting specific enzymes and pembrolizumab activating the immune system to attack cancer cells.

What prior FDA approvals exist?

For the treatment of liver cancer, the FDA has approved several drugs that either inhibit enzymes or activate the immune system. Sorafenib, a multitargeted tyrosine kinase inhibitor, was one of the first approved enzyme inhibitors for advanced hepatocellular carcinoma (HCC). It blocks RAF kinase and the vascular endothelial growth factor receptor (VEGFR). Pembrolizumab, an immune checkpoint inhibitor, has shown promising results in treating various cancers, including liver cancer, by enhancing the body's immune response against tumor cells. These treatments align with the mechanisms of action being studied in the trial involving futibatinib (an enzyme inhibitor) and pembrolizumab (an immune system activator).

What other types of research exist?

Promising alternatives for liver cancer treatment in 2024 include: 1) Atezolizumab plus Bevacizumab, which has shown efficacy in high-risk hepatocellular carcinoma post-resection or ablation (IMbrave 050 trial). 2) Cabozantinib and Nivolumab combination, which has converted locally advanced hepatocellular carcinoma into resectable disease with enhanced antitumor immunity. 3) Sorafenib as an adjuvant therapy post-resection or ablation, which has been evaluated in the STORM trial.

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Tyrosine Kinase Inhibitor

Futibatinib + Pembrolizumab for Liver Cancer

Q: What is the mechanism of action of this treatment?

Liver cancer treatments often target specific molecular pathways to inhibit tumor growth and enhance the body's immune response. Futibatinib, an enzyme inhibitor, blocks enzymes necessary for cancer cell growth, thereby slowing or stopping tumor progression. Pembrolizumab, an immune checkpoint inhibitor, activates the immune system by blocking proteins that prevent immune cells from attacking cancer cells. This dual approach of enzyme inhibition and immune system activation is crucial for liver cancer patients as it targets the cancer from multiple angles, potentially improving treatment efficacy and patient outcomes.

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)

Must not have

Known active human immunodeficiency virus (HIV) infection (defined as patients who are not on anti-retroviral treatment and have detectable viral load and CD4+ < 500/ml)

Active central nervous system (CNS) metastasis and/or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the effect of combining futibatinib and pembrolizumab in treating patients with advanced liver cancer that is FGF19 positive. Futibatinib blocks enzymes needed for cancer cell growth, while pembrolizumab helps the immune system attack the cancer. The goal is to see if this combination can effectively treat these patients.

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.

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.

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 below

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I am 18 years old or older.

Select...

My tumor is FGF19 positive.

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I have had at least one treatment for liver cancer.

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My liver cancer is at an early to intermediate stage.

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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.

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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.

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My liver function is relatively good.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have HIV with a detectable viral load and low CD4 count, and I'm not on treatment.

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My cancer has spread to my brain or its coverings.

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I do not have serious or unmanaged heart conditions.

Select...

I do not have any severe infections or mental health issues that would prevent me from following the study's requirements.

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I have not had any other cancer within the last 6 months.

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I have hepatitis B with a viral load of 100 IU/ml or more.

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There is a known treatment that could cure or extend my life.

Select...

I have had an organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Change in quality of life (QOL)

Incidence of adverse events

Overall response rate (ORR)

+1 more

Awards & Highlights

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: 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 3

~3150

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Liver cancer treatments often target specific molecular pathways to inhibit tumor growth and enhance the body's immune response. Futibatinib, an enzyme inhibitor, blocks enzymes necessary for cancer cell growth, thereby slowing or stopping tumor progression. Pembrolizumab, an immune checkpoint inhibitor, activates the immune system by blocking proteins that prevent immune cells from attacking cancer cells. This dual approach of enzyme inhibition and immune system activation is crucial for liver cancer patients as it targets the cancer from multiple angles, potentially improving treatment efficacy and patient outcomes.

A Single Nucleotide Mixture Enhances the Antitumor Activity of Molecular-Targeted Drugs Against Hepatocellular Carcinoma.[Effects of cetuximab combined erlotinib on proliferation of human hepatocellular carcinoma cell lines HepG2 and Bel-7402].