Study on the Safety and Effectiveness of MK-1308A, Pembrolizumab, and Lenvatinib for Patients with Advanced Liver Cancer

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What is this study about?

This clinical trial is focused on studying a type of liver cancer known as advanced hepatocellular carcinoma. The study is testing a combination of treatments to see how safe and effective they are for people with this condition. The treatments being tested include a medication called MK-1308A, which is a combination of two substances, pembrolizumab and quavonlimab, and another medication called lenvatinib. These treatments are being used together as a first-line therapy, which means they are the first treatments given to patients with this type of cancer.

The purpose of the study is to evaluate how well these treatments work and how safe they are for patients. Participants in the study will receive the medications over a period of time, and their health will be monitored closely by medical professionals. The study will look at how the cancer responds to the treatment and any side effects that may occur. The medications are given in different forms: MK-1308A is administered as a solution through an intravenous infusion, while lenvatinib is taken orally in capsule form.

Throughout the study, participants will undergo regular check-ups and tests to assess their response to the treatment. The study aims to gather information on the effectiveness of the treatment in controlling the cancer and improving the quality of life for patients. This research is important for developing new treatment options for people with advanced hepatocellular carcinoma.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying a diagnosis of advanced hepatocellular carcinoma and ensuring other health criteria are met.

The assessment will involve reviewing medical history, current health status, and any previous treatments received.

2 treatment initiation

The treatment phase begins with the administration of MK-1308A and lenvatinib. MK-1308A is given as an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

Lenvatinib is taken orally in the form of capsules. The specific dosage and frequency will be determined by the study team based on individual health needs.

3 ongoing monitoring

Throughout the study, regular monitoring will occur to assess the safety and effectiveness of the treatment. This includes routine health checks, blood tests, and imaging studies to evaluate the response of the cancer to the treatment.

Participants will be observed for any side effects or adverse reactions to the medications. Adjustments to the treatment plan may be made based on these observations.

4 follow-up evaluations

Periodic evaluations will be conducted to measure the objective response rate and other outcomes related to the cancer’s progression.

These evaluations help determine the duration of response and overall survival rates, providing valuable information about the treatment’s impact.

5 completion of study

At the end of the study period, a final assessment will be performed to summarize the treatment’s effects and any long-term outcomes.

Participants will receive information about their health status and any recommended next steps for ongoing care or treatment.

Who Can Join the Study?

The patient must have a confirmed diagnosis of hepatocellular carcinoma (HCC), which is a type of liver cancer. Certain subtypes are not eligible.
The patient must have Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or Stage B disease that cannot be treated with local therapies or has not responded to them, and cannot be cured with surgery or other treatments.
The patient must have a Child-Pugh class A liver score, which is a measure of liver function, within 7 days before starting the study treatment.
The patient must have a predicted life expectancy of more than 3 months.
The patient must have at least one measurable HCC lesion, which is a tumor that can be measured, confirmed by an independent review.
The patient must have an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1, which is a scale used to assess how the disease affects daily living abilities, within 7 days before starting the study treatment.
Patients with controlled hepatitis B can participate if they have been on antiviral therapy for at least 4 weeks and have a low viral load (less than 500 IU/mL) before starting the study drug.
The patient must have adequately controlled blood pressure, with or without medication.
The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.
The study is open to both male and female patients.

Who Cannot Join the Study?

Patients with any other type of cancer besides hepatocellular carcinoma (a type of liver cancer) cannot participate.
Patients who have had a previous treatment that might interfere with the study results are not eligible.
Patients with severe heart problems or uncontrolled high blood pressure cannot join the study.
Patients with active infections that require treatment with antibiotics are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of allergic reactions to similar medications are not eligible.
Patients who are unable to follow the study procedures or attend scheduled visits are excluded.
Patients with a history of drug or alcohol abuse that might affect their ability to participate are not eligible.
Patients who have participated in another clinical trial within the last 30 days are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
IRCCS Humanitas Research Hospital	Rozzano	Italy
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hhwqnecg Vrjn dzujvwgz	Barcelona	Spain
Wgmlsocpzm Sopfdkx Iki Safumce Pho W Pkmhcgjdq	Przemysl	Poland

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	16.03.2021
Poland	Not recruiting	16.03.2021
Spain	Not recruiting	16.03.2021

Trial locations

Investigated drugs:

MK-1308A is a combination of two medications, MK-1308 and MK-3475, that are being studied together to see how well they work in treating advanced liver cancer. This combination is designed to help the body’s immune system fight cancer cells more effectively. The study aims to find out if this combination is safe for patients and how well it can help shrink or control the cancer.

Lenvatinib is a medication that works by blocking certain proteins in the body that help cancer cells grow and spread. It is used in this study to see if it can help improve the treatment of advanced liver cancer when used together with MK-1308A. The goal is to determine if this combination can help control the cancer more effectively than other treatments.

Hepatocellular carcinoma – Hepatocellular carcinoma is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It typically begins as a single tumor that grows larger over time. As the disease progresses, it can spread to other parts of the liver and potentially to other organs. The cancerous cells can invade blood vessels, leading to further complications. Symptoms may include abdominal pain, weight loss, and jaundice. The progression of the disease can vary, with some cases advancing more rapidly than others.

Trial ID:

2023-505698-34-00

Protocol code:

MK1308A-004

NCT ID:

NCT04740307

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of MK-1308A, Pembrolizumab, and Lenvatinib for Patients with Advanced Liver Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?