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PD-1 Inhibitor
Regorafenib + Pembrolizumab for Liver Cancer
Phase 2
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Tumor tissue obtained within 180 days of enrollment and after the last dose of most recent anti-cancer therapy.
Barcelona Clinic Liver Cancer (BCLC) stage B or C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 45 months
Awards & highlights
Study Summary
This trial is testing a new way to treat people suffering from liver cancer. Researchers are looking at the safety and effectiveness of the trial treatment, regorafenib, when taken with another cancer treatment called pembrolizumab.
Who is the study for?
Adults with advanced liver cancer (HCC) that has spread and didn't respond to previous PD-1/PD-L1 immune checkpoint inhibitors. They must have tried at least two doses of these treatments, have a specific stage of liver cancer (BCLC B or C), good liver function (Child-Pugh Class A), be in fairly good health overall (ECOG 0 or 1), and have measurable disease by scans. Those with treated hepatitis B are eligible if their viral load is low.Check my eligibility
What is being tested?
The trial tests Regorafenib combined with Pembrolizumab in patients whose liver cancer has worsened despite prior treatments. It's divided into two phases: an initial pilot phase to see how different groups respond, followed by an expansion phase targeting the more responsive group from the pilot study.See study design
What are the potential side effects?
Possible side effects include high blood pressure, bleeding events, protein in urine, infections requiring systemic therapy, heart issues like unstable angina or recent myocardial infarction, respiratory compromise due to fluid around lungs or abdomen, gastrointestinal disorders causing diarrhea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor sample was taken within the last 6 months and after my last cancer treatment.
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My liver cancer is at an intermediate or advanced stage.
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My liver cancer diagnosis was confirmed through a biopsy or meets AASLD criteria.
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I have been on antiviral therapy for HBV for at least 4 weeks and my viral load is under 500 IU/mL.
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I have received 2 doses or 8 weeks of PD-1/PD-L1 treatment, whichever is longer.
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I have received at least 2 doses of anti-PD-1/PD-L1 medication.
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I am 18 years old or older.
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I have received 2 doses or 8 weeks of PD-1/PD-L1 treatment, whichever is longer.
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My liver cancer is at an intermediate or advanced stage.
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My liver cancer cannot be removed by surgery and needs treatment that affects my whole body.
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I've been on antiviral therapy for HBV for over 4 weeks and my viral load is under 500 IU/mL.
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My liver cancer diagnosis was confirmed through a biopsy or meets AASLD criteria.
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I have had only one prior immunotherapy treatment and it's been at least 28 days since my last dose.
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I have recently had a new biopsy.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am on HBV therapy with a viral load under 500 IU/ml and will continue it during the study.
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I have received at least 2 doses of anti-PD-1/PD-L1 medication.
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My liver cancer cannot be removed by surgery and needs treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 45 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 45 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR) Per RECIST 1.1 by Central Assessment
Secondary outcome measures
Duration of Response (DOR) Per RECIST 1.1 by Central Assessment and Investigator Assessment
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants With Dose Modification
+2 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Regorafenib+PembrolizumabExperimental Treatment2 Interventions
Participants with advanced hepatocellular carcinoma (HCC) progressed on 1L anti-PD-1/PD-L1 therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Regorafenib (Stivarga, BAY73-4506)
2011
Completed Phase 4
~4420
Find a Location
Who is running the clinical trial?
BayerLead Sponsor
2,240 Previous Clinical Trials
25,332,654 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,059,840 Total Patients Enrolled
2 Trials studying Liver Cancer
133 Patients Enrolled for Liver Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have stable brain metastases after treatment.My liver cancer returned after anti-PD-1 therapy and worsened within 6 months of stopping it.I have untreated large esophageal varices at risk of bleeding.My tumor sample was taken within the last 6 months and after my last cancer treatment.I stopped my first-line immune therapy due to severe side effects.I tested positive for hepatitis B core antibodies but don't need HBV treatment.I have been cancer-free for over 3 years, except for certain skin or in situ cancers.My liver cancer is at an intermediate or advanced stage.My liver cancer diagnosis was confirmed through a biopsy or meets AASLD criteria.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have not had a heart attack in the last 6 months.My liver is functioning well according to the Child-Pugh Class A.My tumor sample was taken within the last 6 months after my last cancer treatment.I have at least one tumor that can be measured on a scan, even if it's in an area that was previously treated.I have new or worsening chest pain.I have been on antiviral therapy for HBV for at least 4 weeks and my viral load is under 500 IU/mL.I have received 2 doses or 8 weeks of PD-1/PD-L1 treatment, whichever is longer.I have severe stomach issues that cause a lot of diarrhea.I am currently being treated for a serious infection.I have received at least 2 doses of anti-PD-1/PD-L1 medication.I haven't taken any experimental drugs within the last 28 days or 5 half-lives, whichever is shorter.I am 18 years old or older.My blood pressure is not controlled despite taking medication.My liver is functioning well according to the Child-Pugh Class A.I have received 2 doses or 8 weeks of PD-1/PD-L1 treatment, whichever is longer.My cancer has worsened after treatment targeting PD-1/PD-L1.My liver cancer is at an intermediate or advanced stage.My liver cancer cannot be removed by surgery and needs treatment that affects my whole body.I haven't had severe bleeding in the last 28 days.My cancer has worsened after treatment targeting PD-1/PD-L1.I have hepatitis B but it is under control with treatment.My liver cancer returned after anti-PD-1 therapy and worsened within 6 months of stopping it.My condition can be treated with local therapy aimed at curing it.I have severe kidney issues with high levels of protein in my urine.I have a low hepatitis B viral load and don't need antiviral treatment.I can provide recent tumor tissue or have an exception approved by the sponsor.I've been on antiviral therapy for HBV for over 4 weeks and my viral load is under 500 IU/mL.I have both active hepatitis B and C infections.I haven't had a blood transfusion or received colony stimulating factors in the last month.My liver cancer diagnosis was confirmed through a biopsy or meets AASLD criteria.I have been treated with a tyrosine kinase inhibitor as my first therapy.I am on HBV treatment with a viral load under 500 IU/ml and will continue it during the study.I have had pneumonitis treated with steroids or have it now.My liver cancer is of a specific type (Fibrolamellar or mixed).My cancer has worsened within 3 months after my last anti-PD-1/PD-L1 treatment.I have fluid buildup affecting my breathing.I have had only one prior immunotherapy treatment and it's been at least 28 days since my last dose.I have recently had a new biopsy.I have been treated with regorafenib and immune checkpoint inhibitors.I haven't had a stroke, clot in my leg or lung clot in the last 6 months.I am fully active or restricted in physically strenuous activity but can do light work.I have at least one tumor that can be measured on scans.I can provide recent tumor tissue samples, or I have an exception approved by the sponsor.My cancer has worsened within 3 months after my last anti-PD-1/PD-L1 treatment.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.I am on HBV therapy with a viral load under 500 IU/ml and will continue it during the study.I have received at least 2 doses of anti-PD-1/PD-L1 medication.My liver cancer cannot be removed by surgery and needs treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Regorafenib+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.
For what illness does Pembrolizumab usually provide relief?
"Pembrolizumab is an effective treatment for unresectable melanoma, microsatellite instability high, and patients with a high risk of recurrence."
Answered by AI
How many participants will this trial have in total?
"Right now, this specific study is not looking for new patients to enroll. The first posting was on February 3rd, 2021 and the most recent update was on November 15th, 2022. However, there are 2694 trials actively recruiting participants with liver carcinoma and 1055 studies for Pembrolizumab actively enrolling patients."
Answered by AI
Are there any serious side effects associated with Pembrolizumab?
"Pembrolizumab, while not yet having any efficacy data to support its use, has some safety data from Phase 2 trials."
Answered by AI
Could you elaborate on Pembrolizumab's previous applications in other research?
"Pembrolizumab was first researched in 2010 at City of Hope. So far, there have been a total of 330 completed clinical trials. Out of the 1055 clinical trials that are currently underway, many are based in Oklahoma City, Oklahoma."
Answered by AI
How many different hospitals are participating in this clinical trial?
"Currently, this trial is recruiting patients from 18 different sites. The locations are based in Oklahoma City, Aurora and Orange as well as 18 other locations. To reduce the travel burden for enrollees, it is important to select the clinic closest you."
Answered by AI
Are patients currently being enrolled in this experiment?
"Unfortunately, this study has already completed recruitment and is no longer looking for patients. The trial was initially posted on February 3rd, 2021 but the most recent edit was on November 15th, 2022. If you are seeking other studies, there are 2694 different trials related to liver carcinoma and 1055 different trials involving Pembrolizumab that are actively searching for patients."
Answered by AI
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