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Study of Pembrolizumab and Lenvatinib with TACE for Patients with Incurable Non-metastatic Liver Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of liver cancer called Hepatocellular Carcinoma that cannot be cured and has not spread to other parts of the body. The study is testing a combination of two medications, Pembrolizumab and Lenvatinib, along with a procedure known as Transarterial Chemoembolization (TACE). TACE is a treatment that delivers chemotherapy directly to the liver. The trial will compare this combination to TACE alone to see which is more effective in treating the cancer.

The purpose of the study is to evaluate the safety and effectiveness of the combination treatment. Participants will receive either the combination of Pembrolizumab and Lenvatinib with TACE or a placebo with TACE. The study will monitor how long participants live without the cancer getting worse and their overall survival. Pembrolizumab, also known by its code name MK-3475, is given as an infusion into a vein, while Lenvatinib is taken as a capsule by mouth.

The study will take place over a period of time, with regular check-ups and assessments to monitor the participants' health and the progression of the cancer. The trial aims to provide valuable information on whether the combination of these treatments can offer better outcomes for patients with this type of liver cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, which means you agree to participate after understanding all the details.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and conducting necessary tests to ensure you meet the study criteria.

  3. Step 3

    Randomization

    You will be randomly assigned to one of the study groups. This means you may receive either the combination of pembrolizumab and lenvatinib with TACE or a placebo with TACE. Randomization ensures that the study results are unbiased.

  4. Step 4

    Treatment phase

    If you are in the treatment group, you will receive pembrolizumab through an intravenous infusion. This is a solution given directly into your vein. The dosage is 25 mg/mL, and the frequency and duration will be determined by the study protocol.

    You will also take lenvatinib orally in capsule form. The specific dosage and frequency will be provided by the study team.

    If you are in the placebo group, you will receive a placebo for pembrolizumab and lenvatinib, along with TACE.

  5. Step 5

    Regular monitoring

    Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment. This includes physical exams, blood tests, and imaging studies to assess the progression of your condition.

  6. Step 6

    End of treatment

    At the end of the treatment phase, a final assessment will be conducted to evaluate the overall impact of the treatment on your condition. This will involve similar tests and evaluations as during the regular monitoring phase.

  7. Step 7

    Follow-up

    After completing the treatment, you will enter a follow-up phase. During this time, you will continue to have periodic check-ups to monitor your health and any long-term effects of the treatment.

Who can join the trial?

7 criteria

  • Must have a diagnosis of hepatocellular carcinoma (HCC), which is a type of liver cancer, confirmed by medical imaging or tissue tests.
  • The cancer must be located in the liver and cannot be treated with surgery or other curative treatments.
  • If you have Hepatitis C virus (HCV), you can participate if you finished treatment at least one month before starting the study.
  • If you have Hepatitis B virus (HBV), you are eligible to participate.
  • Your blood pressure must be well-controlled, whether or not you are taking medication for it.
  • You must have adequate organ function, meaning your organs are working well enough to participate in the study.
  • Both males and females can participate.

Who cannot join the trial?

13 criteria

  • Patients with other serious illnesses that cannot be cured.
  • Patients with cancer that has spread to other parts of the body (metastatic cancer).
  • Patients who have had another type of cancer in the past, unless it was successfully treated and has not returned.
  • Patients who have had a heart attack or stroke in the past 6 months.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver disease, other than the specific type being studied.
  • Patients with active infections that require treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial.
  • Patients who have had an organ transplant.
  • Patients with known allergies to the study drugs.
  • Patients with a history of drug or alcohol abuse.
  • Patients with mental health conditions that might interfere with the study.
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Investigated drugs

  • Lenvatinib

    is a medication used in this clinical trial to help treat liver cancer that cannot be removed by surgery and has not spread to other parts of the body. It works by blocking certain proteins that help cancer cells grow, which may slow down or stop the growth of the cancer.

  • Pembrolizumab

    is another medication used in the trial. It is a type of immunotherapy that helps your immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells, allowing the immune system to better target and destroy the cancer.

  • Transarterial Chemoembolization (TACE)

    is a procedure used in this study to treat liver cancer. It involves delivering chemotherapy directly to the liver tumor through the blood vessels, while also blocking the blood supply to the tumor. This helps to shrink the tumor and limit its growth by cutting off its nutrients and oxygen supply.

What is already known about the treatment

  • Lenvatinib

    Lenvatinib is taken orally in the form of capsules and is currently being studied in combination with other treatments for liver cancer that cannot be cured or has not spread. It is mainly used to treat certain types of cancer, including liver cancer, by blocking specific proteins that help cancer cells grow and spread. Lenvatinib belongs to a group of drugs known as kinase inhibitors, which work at the molecular level to stop cancer cell growth.

  • Pembrolizumab

    Pembrolizumab is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is an established medication in the treatment of various cancers and is being studied for its effectiveness in combination with other treatments for liver cancer that cannot be cured or has not spread. Pembrolizumab works by helping the immune system recognize and attack cancer cells, and it is classified as an immune checkpoint inhibitor.

Investigated diseases

Hepatocellular Carcinoma – Hepatocellular carcinoma is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It typically develops in the context of chronic liver disease, often related to hepatitis or cirrhosis. The disease progresses as the cancerous cells multiply and form a tumor, which can grow and spread to other parts of the liver and potentially to other organs. As the tumor enlarges, it may disrupt liver function and lead to symptoms such as abdominal pain, weight loss, and jaundice. The progression of hepatocellular carcinoma can vary, with some tumors growing slowly and others advancing more rapidly. The disease is often detected at an advanced stage due to the lack of early symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502116-36-00Protocol codeMK-7902-012Estimated enrolment549 patientsSponsorMerck Sharp & Dohme LLC

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