Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of Pembrolizumab and Lenvatinib for Patients with Advanced Liver Cancer Resistant to Previous Immunotherapy

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 known as advanced stage hepatocellular carcinoma. The study is investigating the effects of two medications, pembrolizumab and lenvatinib. Pembrolizumab, also known by its code name MK-3475, is given as an infusion, which means it is administered directly into the bloodstream through a vein. Lenvatinib is taken orally in the form of capsules. The purpose of the study is to evaluate how well these two medications work together in treating this type of liver cancer.

Participants in the study will receive both pembrolizumab and lenvatinib. The study will observe how the cancer responds to this combination of treatments. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects. The study will last for a period of up to 24 months, during which participants will be monitored regularly to assess the response of their cancer to the treatment. The study aims to determine the effectiveness of the treatment by measuring the rate at which the cancer shrinks or disappears, known as the objective response rate.

Throughout the study, participants will undergo various assessments to monitor their health and the progression of their cancer. These assessments may include imaging tests like MRI or CT scans to measure the size of the cancer. The study will also track the overall survival of participants and any side effects they may experience. The goal is to gather information that could lead to better treatment options for patients with advanced stage hepatocellular carcinoma who have not responded to previous therapies.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the condition is advanced stage hepatocellular carcinoma.

    A physical examination and laboratory tests are performed to assess overall health and organ function. This helps determine if participation in the trial is suitable.

  2. Step 2

    Treatment initiation

    The treatment involves two medications: pembrolizumab and lenvatinib. Pembrolizumab is administered as an intravenous infusion, which means it is given directly into a vein through a drip.

    Lenvatinib is taken orally in the form of hard capsules. The specific dosage and frequency are determined by the study protocol and will be explained by the healthcare team.

  3. Step 3

    Ongoing treatment and monitoring

    Regular visits to the clinic are required for monitoring the response to treatment and managing any side effects. This includes physical exams, blood tests, and imaging studies like CT scans or MRIs.

    The healthcare team will provide guidance on how to manage any side effects and adjust treatment as necessary to ensure safety and effectiveness.

  4. Step 4

    Evaluation of treatment response

    The effectiveness of the treatment is assessed using criteria known as RECIST 1.1, which involves measuring changes in tumor size through imaging studies.

    The primary goal is to determine the objective response rate, which is the percentage of patients experiencing a complete or partial reduction in tumor size.

  5. Step 5

    Completion of study participation

    Upon completion of the treatment period, a final assessment is conducted to evaluate overall health and the outcome of the treatment.

    Participants may be asked to attend follow-up visits to monitor long-term effects and gather additional data for the study.

Who can join the trial?

15 criteria

  • Have a confirmed diagnosis of hepatocellular carcinoma (HCC), which is a type of liver cancer.
  • Have at least one measurable site of disease that can be seen on a CT scan or MRI. If the area was treated with radiation before, it must show signs of getting worse to be considered measurable.
  • Be at least 18 years old.
  • If female, must not be pregnant or breastfeeding. If of childbearing potential, must agree to use birth control during the study and for at least 120 days after the last dose of study treatment.
  • If male, must agree to use birth control during the study and for at least 210 days after the last dose of study treatment, and must not donate sperm during this time.
  • Provide written informed consent to participate in the trial.
  • Have tumor tissue available for testing, preferably from a recent biopsy. If not available, it should be because a biopsy was never done or the tissue was used up in previous tests.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which means being fully active or having some symptoms but still able to carry out light work.
  • Have a life expectancy of at least 12 weeks.
  • Have adequate organ function based on specific laboratory tests.
  • Participants with past or ongoing HCV (Hepatitis C Virus) infection can join if they completed treatment at least 1 month before starting the study and have a low viral load. Participants with controlled hepatitis B can join if they meet certain criteria regarding treatment and viral load.
  • Have blood pressure that is controlled, with or without medication, and is 150/90 mm Hg or lower at the start of the study.
  • Have a tumor that cannot be removed by surgery or treated with local ablation.
  • Have experienced disease progression after at least 4 cycles or 12 weeks of first-line immunotherapy-based treatment.
  • Have a Child-Pugh Classification score of 6 or less, which is a measure of liver function.

Who cannot join the trial?

9 criteria

  • Patients with any other type of cancer besides advanced stage hepatocellular carcinoma cannot participate. Hepatocellular carcinoma is a type of liver cancer.
  • Patients who have received any other cancer treatment within the last 4 weeks are not eligible.
  • Patients with severe heart problems, such as heart failure or a recent heart attack, cannot join the study.
  • Patients with uncontrolled high blood pressure are excluded. This means their blood pressure is not managed well with medication.
  • Patients with active infections, including HIV, hepatitis B, or hepatitis C, cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible to join the study.
  • Patients with a history of severe allergic reactions to similar drugs used in the study cannot participate.
  • Patients with any other serious medical conditions that could interfere with the study are excluded.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Pembrolizumab

    is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. It does this by blocking a specific protein on the surface of cells that usually helps cancer cells hide from the immune system. By blocking this protein, pembrolizumab allows your immune system to better recognize and attack the cancer cells.

  • Lenvatinib

    is a medication that targets certain proteins in the body that help cancer cells grow and spread. It is known as a targeted therapy. Lenvatinib works by blocking these proteins, which can slow down or stop the growth of cancer cells. This medication is used to treat certain types of cancer by interfering with the cancer cells' ability to grow and multiply.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently being studied for its effectiveness in treating advanced stage hepatocellular carcinoma, especially in patients who have not responded to other treatments like atezolizumab and bevacizumab. Pembrolizumab works by helping the immune system recognize and attack cancer cells, specifically by blocking a protein called PD-1 on immune cells, which can otherwise prevent them from attacking cancer. It is classified as an immune checkpoint inhibitor, a type of immunotherapy.

  • Lenvatinib

    Lenvatinib is taken orally in the form of a capsule. It is being investigated for its potential to treat advanced stage hepatocellular carcinoma in combination with pembrolizumab. Lenvatinib works by blocking certain proteins that promote the growth of blood vessels in tumors, effectively starving the cancer cells of nutrients and slowing their growth. It is classified as a tyrosine kinase inhibitor, which is a type of targeted cancer therapy.

Investigated diseases

Hepatocellular carcinoma – Hepatocellular carcinoma is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It often develops in the context of chronic liver disease, such as cirrhosis or hepatitis. The disease typically progresses by forming a mass in the liver, which can grow and spread to other parts of the body. As it advances, it may cause symptoms like abdominal pain, weight loss, and jaundice. The progression can lead to liver dysfunction and complications related to the spread of cancer cells. The disease is characterized by its ability to invade blood vessels and metastasize to distant organs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515731-29-00Protocol codeSOLARISEstimated enrolment32 patientsSponsorFrankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).