Trial Summary
What is the purpose of this trial?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.
Is the drug Futibatinib, Pembrolizumab a promising treatment for liver cancer?Yes, the drug Futibatinib, Pembrolizumab is promising for liver cancer. Research shows that Pembrolizumab, part of this drug combination, has shown positive results in treating advanced liver cancer, helping patients who have already tried other treatments.24679
What safety data exists for the treatment of Futibatinib and Pembrolizumab for liver cancer?The safety data for Pembrolizumab (also known as KEYTRUDA or MK-3475) has been evaluated in various trials for different cancers, including hepatocellular carcinoma (HCC). In the KEYNOTE-224 trial, Pembrolizumab was assessed for safety in patients with advanced HCC previously treated with sorafenib. Additionally, a phase III trial compared Pembrolizumab to a placebo in Asian patients with advanced HCC. Common adverse reactions to Pembrolizumab include fatigue, cough, nausea, pruritus, rash, decreased appetite, constipation, arthralgia, and diarrhea. Immune-mediated adverse reactions can include pneumonitis, colitis, hepatitis, hypophysitis, and thyroid disorders. These safety profiles are based on trials for various cancers, not specifically for the combination of Futibatinib and Pembrolizumab in liver cancer.12348
What data supports the idea that Futibatinib + Pembrolizumab for Liver Cancer is an effective treatment?The available research shows that pembrolizumab, one of the drugs in the combination, has been effective in treating advanced liver cancer, especially in patients who have already tried other treatments like sorafenib. Studies like KEYNOTE-224 and KEYNOTE-240 have shown that pembrolizumab can help control the disease and is generally well-tolerated by patients. However, there is no specific data provided on the combination of Futibatinib and Pembrolizumab for liver cancer, so we can't directly compare it to other treatments based on the information available.25679
Do I need to stop my current medications to join the trial?The trial protocol does not specify if you need to stop your current medications. However, you must not have received systemic anticancer therapy, strong inhibitors and inducers, or sensitive substrates of CYP3A4 within 2 weeks prior to registration. It's best to discuss your current medications with the trial team.
Eligibility Criteria
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.Inclusion Criteria
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 have at least one tumor that can be measured and hasn't been treated with radiation or targeted liver therapy.
My liver cancer cannot be treated with surgery, transplant, or targeted therapies.
My liver cancer diagnosis was confirmed through imaging or biopsy.
I can take care of myself and am up and about more than half of my waking hours.
My liver function is relatively good.
Exclusion Criteria
I have HIV with a detectable viral load and low CD4 count, and I'm not on treatment.
My cancer has spread to my brain or its coverings.
I do not have serious or unmanaged heart conditions.
I do not have any severe infections or mental health issues that would prevent me from following the study's requirements.
I have not had any other cancer within the last 6 months.
I have hepatitis B with a viral load of 100 IU/ml or more.
There is a known treatment that could cure or extend my life.
I have had an organ transplant.
Treatment Details
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.
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.
Futibatinib is already approved in United States for the following indications:
🇺🇸 Approved in United States as Lytgobi for:
- Treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements
Find a clinic near you
Research locations nearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
National Cancer Institute (NCI)Collaborator
References
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]On September 4, 2014, the FDA approved pembrolizumab (KEYTRUDA; Merck Sharp & Dohme Corp.) with a recommended dose of 2 mg/kg every 3 weeks by intravenous infusion for the treatment of patients with unresectable or metastatic melanoma who have progressed following treatment with ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Approval was based on demonstration of objective tumor responses with prolonged response durations in 89 patients enrolled in a randomized, multicenter, open-label, dose-finding, and activity-estimating phase 1 trial. The overall response rate (ORR) by blinded independent central review per RECIST v1.1 was 24% (95% confidence interval, 15-34); with 6 months of follow-up, 86% of responses were ongoing. The most common (≥20%) adverse reactions were fatigue, cough, nausea, pruritus, rash, decreased appetite, constipation, arthralgia, and diarrhea. Immune-mediated adverse reactions included pneumonitis, colitis, hepatitis, hypophysitis, and thyroid disorders. The benefits of the observed ORR with prolonged duration of responses outweighed the risks of immune-mediated adverse reactions in this life-threatening disease and represented an improvement over available therapy. Important regulatory issues in this application were role of durability of response in the evaluation of ORR for accelerated approval, reliance on data from a first-in-human trial, and strategies for dose selection. Clin Cancer Res; 23(19); 5666-70. ©2017 AACR.
Pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib (KEYNOTE-224): a non-randomised, open-label phase 2 trial. [2022]Immune checkpoint blockade therapy has shown promising results in patients with advanced hepatocellular carcinoma. We aimed to assess the efficacy and safety of pembrolizumab in this patient population.
FDA Approves Pembrolizumab for BCG-Unresponsive NMIBC. [2021]The FDA approved pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or chose to not undergo cystectomy.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]A phase II trial investigating the therapeutic effect of neoadjuvant programmed cell death 1 (PD-1) inhibitor pembrolizumab (MK-3475, KEYTRUDA®) administered prior to surgery for the treatment of non-small cell lung cancer (NSCLC) has been conducted (NCT03197467). We report the first clinical results of a planned interim safety analysis after 15 patients were enrolled.
Pembrolizumab as Second-Line Therapy for Advanced Hepatocellular Carcinoma: A Subgroup Analysis of Asian Patients in the Phase 3 KEYNOTE-240 Trial. [2023]KEYNOTE-240 investigated the efficacy and safety of pembrolizumab plus best supportive care (BSC) in sorafenib-treated patients with advanced hepatocellular carcinoma (HCC). Results for the subgroup of patients from Asia are described.
Updated efficacy and safety of KEYNOTE-224: a phase II study of pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib. [2022]Pembrolizumab, a PD-1 inhibitor, demonstrated anti-tumour activity and tolerability in patients treated with sorafenib and with advanced hepatocellular carcinoma in KEYNOTE-224. Longer-term efficacy and safety after ∼2.5 years of additional follow-up are reported.
Pembrolizumab Monotherapy for Previously Untreated Advanced Hepatocellular Carcinoma: Data from the Open-Label, Phase II KEYNOTE-224 Trial. [2023]KEYNOTE-224 cohort 1 demonstrated that pembrolizumab was efficacious and tolerable in patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. We report results from KEYNOTE-224 (NCT02702414) cohort 2, which enrolled patients with advanced HCC and no prior systemic therapy.
Pembrolizumab Versus Placebo as Second-Line Therapy in Patients From Asia With Advanced Hepatocellular Carcinoma: A Randomized, Double-Blind, Phase III Trial. [2023]We evaluated the efficacy and safety of pembrolizumab in patients from Asia with previously treated advanced hepatocellular carcinoma (HCC).
Lenvatinib plus pembrolizumab versus lenvatinib plus placebo for advanced hepatocellular carcinoma (LEAP-002): a randomised, double-blind, phase 3 trial. [2023]Systemic therapies have improved the management of hepatocellular carcinoma, but there is still a need to further enhance overall survival in first-line advanced stages. This study aimed to evaluate the addition of pembrolizumab to lenvatinib versus lenvatinib plus placebo in the first-line setting for unresectable hepatocellular carcinoma.