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Tyrosine Kinase Inhibitor

Pembrolizumab/Quavonlimab + Lenvatinib for Liver Cancer

Phase 2

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has an HCC diagnosis confirmed by radiology, histology, or cytology (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible)

Has at least 1 measurable HCC lesion based on RECIST 1.1, confirmed by BICR

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

Study Summary

This trial will test a new cancer treatment in people with liver cancer. The treatment consists of two drugs, and it will be tested to see if it is safe and effective.

Who is the study for?

This trial is for adults with advanced liver cancer (Hepatocellular Carcinoma) who haven't had certain treatments. They should have a specific stage of the disease, good liver function, controlled blood pressure, and no major health issues like brain metastases or recent surgeries. People with HIV, active infections besides hepatitis B/C, severe allergies to study drugs, or other cancers aren't eligible.Check my eligibility

What is being tested?

The trial tests a combination of two drugs: Pembrolizumab/Quavonlimab and Lenvatinib in patients with first-line Hepatocellular Carcinoma. It aims to see how safe this combo is and how well it works against this type of liver cancer without comparing it to another treatment.See study design

What are the potential side effects?

Possible side effects include immune-related reactions that can affect organs, high blood pressure due to Lenvatinib, fatigue, skin rash, loss of appetite and digestive issues such as diarrhea. Each patient may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with liver cancer, but not the fibrolamellar or mixed subtype.

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I have a liver cancer lesion that can be measured.

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My liver cancer is at a stage where it cannot be cured with surgery or local treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants discontinuing study treatment due to an AE

Number of participants with a Dose-Limiting Toxicity (DLT) in the Safety Lead-in Phase

Number of participants with ≥1 adverse event (AE)

+4 more

Secondary outcome measures

DCR per mRECIST as assessed by BICR

DOR per mRECIST as assessed by BICR

Disease Control Rate (DCR) per RECIST 1.1 as assessed by BICR

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab/Quavonlimab + LenvatinibExperimental Treatment3 Interventions

Participants receive pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years, plus lenvatinib orally (based on actual body weight at screening) until progressive disease or unacceptable toxicity for up to 5 years. In the event of discontinuation of pembrolizumab/quavonlimab due to intolerable toxicity, re-initiation of treatment with pembrolizumab may be considered.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenvatinib

2005

Completed Phase 4

~2690

Pembrolizumab

2017

Completed Phase 2

~2010

Pembrolizumab/Quavonlimab

2017

Completed Phase 2

~420

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,582,173 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,887 Previous Clinical Trials

5,054,864 Total Patients Enrolled

2 Trials studying Liver Cancer

133 Patients Enrolled for Liver Cancer

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,754 Total Patients Enrolled

Media Library

Liver Cancer Research Study Groups: Pembrolizumab/Quavonlimab + Lenvatinib

Liver Cancer Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT04740307 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals are being sought through this clinical experimentation?

"This medical trial's primary objective is to assess the number of participants that experience a hepatic adverse event (AE) over an approximately 3-week period. Secondary outcomes involve evaluating Progression Free Survival per modified Response Evaluation Criteria In Solid Tumors (mRECIST), Disease Control Rate (DCR) according to Response Evaluation Criteria in Solid Tumors 1.1, and Duration Of Response as assessed by BICR using the same criteria."

Answered by AI

Could you please elaborate on the previous scientific research conducted with Pembrolizumab/Quavonlimab?

"As of now, 1032 investigations are ongoing involving Pembrolizumab/Quavonlimab with 134 being in the advanced Phase 3. Although many trials for this treatment take place in Sacramento, California, a total of 37061 sites are conducting studies."

Answered by AI

What medical conditions have been successfully treated with Pembrolizumab/Quavonlimab?

"Pembrolizumab/Quavonlimab is often prescribed for the treatment of malignant neoplasms. It may also be used to treat unresponsive melanoma, microsatellite instability high and cases in which chemotherapy does not yield desirable results."

Answered by AI

What is the current participant count in this experiment?

"Unfortunately, this research study has already ceased recruitment. It was originally listed on March 16th 2021 and the most recent update occurred on June 27th 2022. Although no longer enrolling for this particular trial, there are currently 2594 trials actively searching for individuals with carcinoma hepatocellular and 1032 studies involving Pembrolizumab/Quavonlimab looking to recruit patients."

Answered by AI

Has the FDA granted formal authorization to Pembrolizumab/Quavonlimab?

"The safety of Pembrolizumab/Quavonlimab can be estimated to lie at a level 2, as phase two clinical trials have only provided evidence for its security and not effectiveness."

Answered by AI

Is there an ongoing enrollment process for this research experiment?

"This clinical trial is not open to recruitment at this time. The original posting was dated March 16th 2021, and the last update occurred on June 27th 2022. However, there are currently 2594 studies actively enrolling patients with carcinoma hepatocellular and 1032 trials for Pembrolizumab/Quavonlimab that need participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Coformulated Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib (E7080/MK-7902) in Advanced Hepatocellular Carcinoma (MK-1308A-004)

2021. "Safety and Efficacy of Coformulated Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib (E7080/MK-7902) in Advanced Hepatocellular Carcinoma (MK-1308A-004)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04740307.

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