Not recruiting

Study on Advanced Liver Cancer: Evaluating Livmoniplimab and Budigalimab in Patients Without Prior Systemic Treatment

Verified siteRegistered drugNo placebo

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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 known as Hepatocellular Carcinoma (HCC), which is either locally advanced or has spread to other parts of the body (metastatic). The study is investigating the effects of two medications, Livmoniplimab and Budigalimab, when used together. These medications are given as a solution through an infusion, which means they are delivered directly into the bloodstream. The purpose of the study is to find the best dose of Livmoniplimab in combination with Budigalimab and to evaluate how effective and safe this combination is for patients who have not received any previous systemic treatment for their HCC.

The study is divided into two stages. In the first stage, the focus is on determining the optimal dose of Livmoniplimab when used with Budigalimab. In the second stage, the study aims to assess the effectiveness of this combination in improving the overall survival of patients. Throughout the study, some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment. The study will monitor various outcomes, including how long patients live, the progression of the disease, and any side effects experienced.

Participants in this study will receive the treatment over a period of time, with regular check-ups to monitor their health and the progress of the cancer. The study is expected to continue until 2030, with recruitment of participants starting in 2024. This trial is an important step in finding new and effective treatments for patients with advanced liver cancer, offering hope for improved outcomes in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be required to sign an informed consent form. This document confirms the patient's understanding and agreement to participate in the study.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes a review of medical history, current health status, and laboratory tests to ensure all criteria are met.
Step 3
Treatment phase 1
The first phase of treatment involves the administration of livmoniplimab and budigalimab. These medications are given as a solution for infusion, which means they are delivered directly into the bloodstream through a vein.
The primary goal of this phase is to determine the optimal dose of livmoniplimab in combination with budigalimab.
Step 4
Treatment phase 2
In the second phase, the focus is on evaluating the effectiveness of the livmoniplimab and budigalimab combination. This phase also involves monitoring overall survival rates.
The medications continue to be administered as a solution for infusion.
Step 5
Monitoring and follow-up
Throughout the study, regular monitoring will be conducted to assess the patient's response to treatment and any side effects. This includes physical examinations, imaging tests, and laboratory tests.
Follow-up visits will be scheduled to ensure ongoing evaluation of the patient's health and treatment efficacy.
Step 6
Completion of the study
Upon completion of the study, a final assessment will be conducted. This includes a comprehensive review of the patient's health status and the overall outcomes of the treatment.
The study is estimated to conclude by July 2030.

Who can join the trial?

16 criteria

You must sign a consent form, or have a legal representative sign it, before starting any study procedures.
If you have a Hepatitis B Virus (HBV) infection, your HBV DNA level must be less than 500 IU/mL, and you must be on anti-HBV treatment for at least 14 days before the first dose and continue treatment during the study and for at least 6 months after the last dose.
If you had a past HBV infection, you must agree to regular HBV DNA monitoring and start antiviral therapy if the virus becomes detectable.
You must not have had severe allergic reactions to any IgG-containing agent or monoclonal antibody (mAb).
You can participate if you have conditions like vitiligo, alopecia, stable hypothyroidism, controlled celiac disease, type 1 diabetes on insulin, or controlled HIV.
You must not have an active SARS-CoV-2 infection. If you have symptoms, you need a negative test result to participate.
You must not have any condition or treatment that could interfere with the study or your participation, as judged by the investigator.
You must not have had significant health issues in the last 6 months, such as severe nerve damage, heart failure, unstable heart conditions, high blood pressure, or lung diseases.
You must not have had significant drug or alcohol abuse in the last 6 months.
You must be at least 18 years old and weigh at least 35 kg (about 77 pounds).
Your lab test results must meet specific criteria, such as certain levels of hemoglobin, neutrophils, platelets, liver enzymes, bilirubin, kidney function, albumin, lipase, and urine protein.
You must be willing and able to follow the study procedures.
You must have advanced or metastatic liver cancer (HCC) that cannot be removed by surgery, confirmed by medical tests.
Your cancer must be at a specific stage (BCLC Stage B or C) and not treatable by surgery or local therapies.
You must not have received any previous systemic treatment for HCC, such as chemotherapy or immunotherapy.
You must have at least one measurable liver cancer lesion, as determined by medical imaging.

Who cannot join the trial?

7 criteria

Patients who have already received systemic treatment for **HCC** (Hepatocellular Carcinoma, a type of liver cancer) cannot participate.
Patients with other serious health conditions that might interfere with the study may be excluded.
Patients who are unable to follow the study procedures or attend scheduled visits may not be eligible.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients with a history of allergic reactions to similar medications may be excluded.
Patients with certain infections or diseases that could affect the study results may not be eligible.
Patients who are participating in another clinical trial at the same time may be excluded.

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Verified sites

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

Verified
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy
Verified
Azienda Unita Sanitaria Locale Di Bologna
Bologna, Italy
Verified
CHU Grenoble Alpes
La Tronche, France

Trial locations

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Investigated drugs

Livmoniplimab
is an investigational medication being studied for its potential to treat liver cancer that has spread or is locally advanced. It is being tested to find the best dose when used in combination with another medication. The goal is to see if it can help improve the survival of patients who have not yet received any other treatments for their liver cancer.
Budigalimab
is another investigational medication used in this study alongside livmoniplimab. It is being evaluated to see how well it works with livmoniplimab in treating liver cancer that is either locally advanced or has spread to other parts of the body. The combination aims to improve patient outcomes by potentially enhancing the effectiveness of the treatment.

What is already known about the treatment

Livmoniplimab
Livmoniplimab is administered intravenously and is currently being studied in clinical trials for its potential use in treating metastatic hepatocellular carcinoma (HCC). It is in the experimental phase, with ongoing research to determine its optimal dosage and effectiveness. The medication is primarily indicated for patients with advanced liver cancer who have not received prior systemic treatment. Livmoniplimab works by targeting specific proteins on cancer cells, helping the immune system recognize and attack these cells. It is classified as an immunotherapy agent.
Budigalimab
Budigalimab is given through intravenous infusion and is under investigation in clinical trials for its role in treating metastatic hepatocellular carcinoma (HCC). It is not yet approved for general medical use, as studies are assessing its safety and efficacy in combination with other treatments. The main therapeutic use is for patients with advanced liver cancer who have not undergone previous systemic therapy. Budigalimab functions by modulating the immune response to enhance the body's ability to fight cancer cells. It belongs to the class of monoclonal antibodies.

Investigated diseases

Metastatic Hepatocellular Carcinoma – This is a type of liver cancer that has spread beyond the liver to other parts of the body. It often begins as a single tumor in the liver and can grow and spread to nearby blood vessels or other organs. As the disease progresses, it may cause symptoms such as abdominal pain, weight loss, and jaundice. The cancer cells can travel through the bloodstream or lymphatic system, leading to metastasis in distant organs. The progression of the disease can vary, with some patients experiencing rapid growth and others having a slower course. The spread of cancer cells makes it more challenging to manage and treat effectively.