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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

Must not have

Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib

Has serious nonhealing wound, ulcer, or bone fracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I have a condition that affects how my body absorbs medication.

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I have a serious wound or fracture that is not healing.

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I have both active hepatitis B and C infections.

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I have been treated for an autoimmune disease in the last 2 years.

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I have a bleeding disorder or I'm on blood thinners like warfarin.

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I have received chemotherapy or other treatments for liver cancer.

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I have a severe fistula.

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I have another cancer that is getting worse or was treated in the last 3 years.

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I had radiation therapy on a part of my body other than the liver within the last 2 weeks.

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I have had bleeding from varices in my esophagus or stomach in the past 6 months.

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I have or had cancer spread to my brain or spinal cord.

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My liver cancer has spread to my heart or the large vein carrying blood to my heart.

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I have noticeable fluid buildup in my abdomen.

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I have been treated with specific immune therapy for cancer.

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I have not had serious heart problems in the last year.

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I have or had lung inflammation that needed steroids.

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I cannot undergo any CT or MRI scans with contrast due to medical reasons.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.

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I have coughed up bright red blood recently.

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I have received an organ or tissue transplant from another person.

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

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

Primary study objectives

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 study objectives

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

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: 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

2017

Completed Phase 4

~2070

Pembrolizumab/Quavonlimab

2017

Completed Phase 2

~420