RecruitingRare disease

A study testing visugromab, nivolumab, and lenvatinib for patients with advanced liver cancer that cannot be removed by surgery after previous treatment failed

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 study involves people with hepatocellular carcinoma, which is a type of liver cancer that cannot be removed by surgery or has spread to other parts of the body. The study is for people whose cancer has gotten worse after trying a first treatment that included a specific type of medicine called an anti-PD-(L)1 compound. The study will test several medicines: visugromab (also known as CTL-002), nivolumab, and lenvatinib. Some people in the study will receive visugromab combined with nivolumab and lenvatinib, while others will receive placebo along with lenvatinib. Sodium chloride solution will be used to prepare the medicines for infusion into the vein. The purpose of the study is to see how well visugromab works when combined with nivolumab and lenvatinib compared to placebo and lenvatinib in controlling the cancer.

During the study, participants will receive their assigned treatment for up to 36 months. Visugromab and nivolumab will be given through a vein, while lenvatinib will be taken by mouth as capsules. The study will check how the cancer responds to treatment by looking at scans and other tests. Doctors will measure how long it takes before the cancer gets worse and how long people live. They will also check for any side effects from the medicines and ask participants questions about how they are feeling and their quality of life.

Before joining the study, participants must have cancer that can be measured on scans and must have tried one previous treatment that included an anti-PD-(L)1 medicine for at least 12 weeks. Their liver function must be in good condition, and they must have adequate blood counts, kidney function, and other organ functions. The study will monitor participants throughout treatment to track both how well the treatment works and any side effects that may occur.

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
Initial treatment phase
Upon joining the study, your assigned treatment will begin. The study compares different medication combinations to determine their effectiveness.
You will receive one of two possible treatment combinations. The specific combination assigned to you will be determined randomly, and neither you nor your doctor will know which combination you are receiving during the study.
The first possible combination includes visugromab given through a vein, nivolumab given through a vein, and lenvatinib taken by mouth.
The second possible combination includes two inactive substances (placebos) given through a vein and lenvatinib taken by mouth.
All medications given through a vein will be administered as infusions at the study site.
Step 2
Regular treatment visits
You will need to attend regular visits at the study site to receive the medications that are given through a vein.
During these visits, you will receive infusions of either the active medications or inactive substances, depending on your assigned treatment group.
You will take lenvatinib by mouth as part of your treatment regimen.
The study staff will monitor your health and any side effects you may experience during each visit.
Step 3
Health monitoring and assessments
Throughout the study, regular assessments will be conducted to monitor the status of your condition.
These assessments will include imaging scans to measure any changes in your tumor size.
Blood tests will be performed regularly to check your organ function, blood cell counts, and other health indicators.
Your weight will be measured at regular intervals during the study.
You will be asked to complete questionnaires about your quality of life and how you are feeling.
Step 4
Safety monitoring
Any side effects or health changes you experience will be recorded and monitored throughout the study.
The study team will track all adverse events, including those related to the study medications and those related to your immune system.
If you experience any side effects, the study doctors will assess their severity and may adjust your treatment if necessary.
Serious health events will be closely monitored and managed by the study team.
Step 5
Continuation of treatment
You will continue receiving your assigned treatment combination until your disease progresses, you experience unacceptable side effects, or you decide to withdraw from the study.
The study team will regularly evaluate whether the treatment is working based on imaging scans and other assessments.
Treatment will continue as long as it is deemed safe and potentially beneficial for you.
Step 6
End of treatment and follow-up
Once you stop receiving the study medications, you will enter a follow-up period.
During this period, the study team will continue to monitor your health and survival status.
If you are female and of childbearing potential, or if you are male with a female partner of childbearing potential, you must continue using effective birth control methods for 180 days after receiving your last dose of study medication.
Follow-up assessments may include health checks and questionnaires to track your long-term outcomes.

Who can join the trial?

15 criteria

You must have a confirmed diagnosis of hepatocellular carcinoma, which is a type of liver cancer that cannot be removed by surgery or has spread to other parts of the body, and cannot be cured with available treatments
Your cancer must be measurable on imaging scans and if you had previous local treatments to the liver such as ablation (destroying tissue with heat or cold) or embolization (blocking blood supply to the tumor), the tumors being measured must either not have been treated before or must have grown after treatment
You must have already received one prior treatment for your liver cancer that included a specific type of immunotherapy called an anti-PD-(L)1 checkpoint inhibitor, and you must have been on this treatment for at least 12 weeks without your cancer getting worse during that time
Your previous cancer treatment must have stopped working while you were still receiving the immunotherapy, and you cannot join if you stopped treatment only because of side effects or other reasons without the cancer progressing
You must be at least 18 years old
Your doctor must estimate that you have at least 3 months to live
You must be able to care for yourself and be up and about for more than half of your waking hours, which is measured by a score of 0 or 1 on the ECOG Performance Status scale
Your liver function must be good, with a Child-Pugh score of A6 or better, which is a way to measure how well your liver is working
Your body organs must be working adequately, including your bone marrow making enough blood cells, your kidneys filtering waste properly, your liver enzymes not being too high, your thyroid hormone levels being normal, and your blood clotting normally
Any side effects from previous cancer treatments must have improved to mild levels or gone away completely, except for hair loss and tiredness
If you are a woman who can become pregnant, you must have a negative pregnancy test within 7 days before starting the study treatment
If you are a woman who can become pregnant, you must agree to use highly effective birth control during the study and for 180 days after your last dose of study medication
If you are a man with a female partner who can become pregnant, you must agree to use birth control during the study and for 180 days after your last dose of study medication
You must be able to understand the purpose of the study, sign the consent form, and follow the study procedures including completing electronic questionnaires
You must have documentation of your hepatitis status, which means test results showing whether you have hepatitis virus infection

Who cannot join the trial?

3 criteria

The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
Without detailed exclusion criteria information, it is not possible to list specific conditions or situations that would prevent participation in this clinical trial
Typically, exclusion criteria may include things like other serious medical conditions, certain medications being taken, previous treatments, or specific laboratory test results that fall outside acceptable ranges, but these specific details are not available in the provided information

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Verified sites

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

Verified
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Verified
Azienda Unita Sanitaria Locale Della Romagna
Faenza, Italy
Verified
Azienda Unita Sanitaria Locale Di Bologna
Bologna, Italy

Trial locations

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Investigated drugs

Visugromab
is an investigational medication being studied in this trial. It is given in combination with other treatments to see if it can help fight liver cancer that has spread or cannot be removed by surgery.
Nivolumab
is a type of immunotherapy medication that helps your immune system recognize and attack cancer cells. It works by blocking a protein that prevents immune cells from killing cancer cells.
Lenvatinib
is a targeted therapy medication that works by blocking the growth of new blood vessels that tumors need to grow. This can help slow down or stop the growth of cancer.

What is already known about the treatment

Visugromab
Visugromab is an investigational medication currently being studied in clinical trials for the treatment of liver cancer that cannot be surgically removed or has spread to other parts of the body. It is administered in combination with other cancer medications (nivolumab and lenvatinib) and is being tested specifically in patients whose previous treatment with immune checkpoint inhibitors has not been successful. The medication works by targeting specific molecules involved in tumor growth and the immune system's response to cancer, though its exact mechanism is still under investigation. Visugromab belongs to a class of drugs designed to enhance the body's immune response against cancer cells.
Nivolumab
Nivolumab is an approved cancer treatment medication given through intravenous infusion (directly into a vein) that is widely used in medical practice for various types of cancer, including liver cancer. It works by blocking a protein called PD-1 on immune cells, which normally acts as a brake on the immune system, thereby allowing the body's own immune cells to recognize and attack cancer cells more effectively. This medication belongs to a class of drugs called immune checkpoint inhibitors, which help restore the natural ability of the immune system to fight cancer. In this clinical trial, nivolumab is being combined with visugromab and lenvatinib to evaluate whether this combination can improve treatment outcomes for patients with advanced liver cancer.
Lenvatinib
Lenvatinib is an approved oral medication (taken by mouth as a capsule) used in the treatment of various cancers, including liver cancer that cannot be surgically removed or has spread to other areas of the body. It works by blocking multiple proteins that promote the formation of new blood vessels that feed tumors and support cancer cell growth, essentially starving the tumor of nutrients and oxygen it needs to survive. This medication belongs to a class of drugs called multi-kinase inhibitors or targeted therapy agents. Lenvatinib is currently an established treatment option for liver cancer and serves as the backbone therapy in this clinical trial, to which other investigational medications are being added.

Investigated diseases

Hepatocellular Carcinoma – Hepatocellular carcinoma is a type of liver cancer that begins in the main cells of the liver called hepatocytes. This cancer typically develops in people who have chronic liver diseases such as cirrhosis or hepatitis. The disease can be classified as unresectable when the tumor cannot be removed by surgery, or metastatic when the cancer has spread to other parts of the body beyond the liver. As the disease progresses, the cancer cells multiply and can form larger tumors or spread to nearby blood vessels and lymph nodes. Compensated liver function, classified as Child-Pugh A, means that despite the presence of cancer, the liver is still able to perform its essential functions relatively well. The progression of this disease can vary depending on the size and location of tumors, as well as the overall condition of the liver.