Not recruiting

Study on Hepatocellular Carcinoma: Evaluating Livmoniplimab and Budigalimab for Patients with Advanced or Metastatic Cancer After First-Line 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). The study is investigating the effects of two treatments: Livmoniplimab and Budigalimab. These treatments are being tested together to see if they can help patients whose cancer has advanced or spread after receiving a previous treatment that included an immune checkpoint inhibitor, which is a type of drug that helps the immune system fight cancer.

The purpose of the study is to find the best dose of Livmoniplimab when used with Budigalimab and to evaluate how safe and effective this combination is for patients with advanced HCC. Participants in the study will receive these treatments and will be monitored over a period of time to see how their cancer responds. The study will also look at how long the benefits of the treatment last and the overall survival of the patients.

During the study, participants will receive the treatments either as an injection or infusion, which means the medicine is given directly into the bloodstream. The study aims to gather information that could help in developing better treatment options for people with advanced liver cancer 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, eligibility is confirmed based on specific criteria, including liver function and previous treatment history.
A tissue biopsy is conducted to gather necessary information for the study.
Step 2
Initial treatment phase
The treatment involves the administration of two medications: livmoniplimab and budigalimab.
Livmoniplimab is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein.
Budigalimab is also administered as a solution for injection or infusion.
Step 3
Medication dosage and frequency
The dosage of livmoniplimab is optimized during the study to determine the most effective amount.
The frequency and duration of administration are determined by the study protocol and may vary based on individual response.
Step 4
Monitoring and evaluation
Regular monitoring is conducted to assess the safety and effectiveness of the treatment.
The primary goal is to evaluate the response to treatment, specifically looking for confirmed complete response (CR) or partial response (PR) as determined by investigators.
Step 5
Secondary evaluations
Secondary evaluations include measuring the duration of response (DoR), progression-free survival (PFS), and overall survival (OS).
PFS is the time from the start of treatment until the disease progresses or the patient passes away from any cause.
OS is the time from the start of treatment until death from any cause.
Step 6
Completion of the study
The study is estimated to conclude by December 23, 2026.
Final assessments are made to determine the overall outcomes and effectiveness of the treatment.

Who can join the trial?

10 criteria

Patients must have a type of liver cancer called Hepatocellular Carcinoma.
Patients should have a liver function classified as Child-Pugh A, which means their liver is still working relatively well.
Patients need to have an ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0-1, indicating they are fully active or have some symptoms but can still carry out light work.
Patients must have received a treatment called an immune checkpoint inhibitor as part of their first-line treatment for liver cancer.
Patients should not have any symptomatic, untreated, or actively progressing CNS metastases, meaning the cancer has not spread to the brain or central nervous system in a way that is causing symptoms or getting worse.
Patients must have adequate blood and organ function, meaning their blood tests and organ health are within acceptable limits.
A tissue biopsy is required at the screening stage, which involves taking a small sample of tissue for testing.
Both male and female patients are eligible to participate.
Patients must be adults, as the study includes age categories 3 and 4, which typically refer to adults.
The study does not include vulnerable populations, meaning it is not designed for groups that may need special protection or care.

Who cannot join the trial?

4 criteria

Patients with Hepatocellular Carcinoma who have not progressed after an immune CPI-containing regimen in first-line treatment.
Patients who do not have Child-Pugh A liver function. The Child-Pugh score is a system used to assess the severity of liver disease.
Patients who are not in the age range specified for the trial.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Verified
Palermo, Italy
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

Trial locations

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Investigated drugs

Livmoniplimab
is a medication being studied for its potential to treat liver cancer that has advanced or spread to other parts of the body. It is being tested to find the best dose that can be used safely and effectively in combination with another medication. The goal is to see if it can help patients who have not responded to previous treatments.
Budigalimab
is another medication involved in the study, used in combination with livmoniplimab. It is being evaluated to see if it can improve the treatment outcomes for patients with advanced liver cancer. The study aims to determine how well these two medications work together to help patients who have not had success with other therapies.

What is already known about the treatment

Livmoniplimab
This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating hepatocellular carcinoma, a type of liver cancer. It is being evaluated for its safety and effectiveness, particularly in patients who have not responded to previous treatments. 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
This medication is also given intravenously and is under investigation in clinical trials for its role in treating hepatocellular carcinoma. It is being tested in combination with livmoniplimab to determine the best dosage and to assess its effectiveness in patients who have not benefited from other immune-based treatments. 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

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 may initially present with symptoms like abdominal pain, weight loss, or jaundice. As it progresses, the tumor can grow and spread to other parts of the liver or beyond. The progression of the disease can lead to liver dysfunction and complications related to tumor growth. It is the most common form of primary liver cancer in adults.