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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Hochschule Hannover	Hanover	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Uktsbkiwderhrmoquprsa Aiuvmaqw	Augsburg	Germany
Kmrcnczm dxl Unkblfjoilgo Mwzjfxpe Aqn	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	30.03.2022

Trial locations

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.

Investigated diseases:

Hepatic cancer

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 ID:

2024-515731-29-00

Protocol code:

SOLARIS

NCT ID:

NCT05101629

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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