Study of Nivolumab, Relatlimab and Bevacizumab combination for patients with untreated advanced or metastatic liver cancer (hepatocellular carcinoma)

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What is this study about?

This study focuses on patients with advanced hepatocellular carcinoma (liver cancer) that has spread to other parts of the body or cannot be removed by surgery. The research examines a combination treatment using three medications: nivolumab, relatlimab, and bevacizumab. These medications work by helping the body’s immune system fight cancer cells and by blocking the growth of blood vessels that feed tumors.

The study aims to find the best dose of these medications when used together and to determine how well they work compared to using only two of these medications. The research is divided into two parts. In the first part, different dose levels will be tested to ensure the combination is safe. In the second part, some patients will receive all three medications while others will receive only nivolumab and bevacizumab, along with a placebo.

During the study, participants will receive their assigned medications through intravenous infusions. The medications will be given at regular intervals, and patients will be monitored for how well the treatment works and any side effects that may occur. The study team will pay special attention to how the immune system responds to the treatment and will continue to monitor patients for several months after the last dose of medication.

1 Initial treatment assignment

You will be randomly assigned to one of two treatment groups:

Group 1: Treatment with nivolumab and bevacizumab

Group 2: Treatment with nivolumab, bevacizumab, and relatlimab

2 Treatment administration

You will receive medications through intravenous infusion (directly into your vein)

The treatment will continue until your disease worsens or unacceptable side effects occur

Your doctor will determine the appropriate dose based on safety findings from Part 1 of the study

3 Monitoring during treatment

Regular medical examinations will track your response to treatment

Your doctor will monitor for any side effects, including those related to immune system reactions

Imaging tests will be performed to evaluate how your cancer responds to treatment

4 Safety follow-up

After your last treatment, you will be monitored for 30 or 135 days

During this period, any side effects will be tracked and managed

Your doctor will continue to assess your overall health and disease status

5 Treatment completion

The study is expected to continue until December 31, 2025

Your participation may end earlier if your disease worsens or you experience unacceptable side effects

Your doctor will discuss follow-up care options after study completion

Who Can Join the Study?

  • Must be at least 18 years old
  • Must have advanced liver cancer (hepatocellular carcinoma) that has not been previously treated with any systemic therapy (medications that travel through the bloodstream)
  • Must have good physical performance ability, rated as ECOG 0-1 (able to carry out all normal activities or restricted in physically strenuous activity but able to walk and do light work)
  • Must have Child-Pugh A liver function (a scoring system that indicates well-preserved liver function)
  • Must have liver cancer classified as Barcelona Clinical Liver Cancer stage B or C (intermediate or advanced stage of liver cancer)
  • Both men and women may participate in the study
  • Must be able to understand and comply with study requirements
  • Must be willing to provide informed consent to participate in the trial

Who Cannot Join the Study?

  • Prior systemic therapy or treatment for advanced/metastatic liver cancer (HCC)
  • Active brain or spinal cord metastases (cancer that has spread to brain or spine)
  • Severe heart conditions or uncontrolled high blood pressure
  • Active autoimmune disease (when body’s immune system attacks healthy cells)
  • History of severe allergic reactions to study medications
  • Active or chronic hepatitis B or C infection
  • Significant bleeding within past 28 days
  • Major surgery within past 28 days
  • Current use of blood thinning medications
  • Other active cancers requiring treatment
  • Pregnant or breastfeeding women
  • Serious infections requiring treatment
  • Conditions that might interfere with study procedures
  • Use of other investigational drugs within past 28 days
  • History of organ transplant

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Hospital Foch Suresnes France
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Centre Hospitalier Universitaire De Nice Nice France
Institut Sainte Catherine Avignon France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Chtmqf Hxlprmrhlmq Unvnnlzpifugt Rmewl Reims France
Huwadaox Uxuavaknpuadu Mmfsptf Dl Vglatxgcqh Santander Spain
Uvgccohnfvukwlzzsnwci Duqgkokhhmg Akt Duesseldorf Germany
Nwztlvnm Isayvyky Osmaidaoj Iaq Mhfpi Sxjfsfdojsjokqtvhelustvcrzqz Ixoduhym Bqihcajc Cracow Poland
Grkljg Uxhgeiweag Frnkvzlkk Frankfurt Germany
Kqdmacso dda Utcszvvhuktq Mwcfnrva Aps Munich Germany
Fpcxlkblz Pauz Lo Ikjyiqrdvlfzg Buipcsgzq Dkk Hvqauypq Ubtjasnkwrvxa Lo Ppc Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
18.03.2022
Germany Germany
Not recruiting
18.03.2022
Italy Italy
Not recruiting
18.03.2022
Poland Poland
Not recruiting
18.03.2022
Spain Spain
Not recruiting
18.03.2022

Trial locations

Nivolumab is a medication that helps your immune system fight cancer cells. It works by blocking a protein that prevents your immune system from attacking cancer cells, allowing your body’s natural defenses to work better against the disease.

Relatlimab is a medication that also works with your immune system to fight cancer. It targets a different protein that can stop immune cells from working properly. When combined with other treatments, it may help your body’s immune system to better recognize and attack cancer cells.

Bevacizumab is a medication that works by blocking the growth of new blood vessels that feed tumors. By preventing these blood vessels from forming, it can help slow down or stop tumor growth by cutting off their blood supply.

These medications are being studied in combination to treat liver cancer (hepatocellular carcinoma) in patients who haven’t received previous systemic treatment for their cancer.

Investigated diseases:

Hepatocellular Carcinoma (HCC) – A type of primary liver cancer that begins in the main type of liver cells (hepatocytes). The disease typically develops in people with chronic liver conditions, gradually affecting liver function. HCC can remain confined to the liver or spread to other parts of the body (metastatic stage). The cancer develops when liver cells begin to grow abnormally and form tumors. In advanced stages, the cancer can spread beyond the liver to nearby lymph nodes and other organs. The disease progression can affect normal liver functions, including the ability to process nutrients and filter toxins from the blood.

Trial ID:
2024-510649-33-00
Protocol code:
CA224-106
Trial Phase:
Human Pharmacology (Phase I) – Other

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