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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

15 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

  • Nivolumab

    An intravenously administered immunotherapy medication that belongs to the class of PD-1 inhibitors used in cancer treatment. This monoclonal antibody works by blocking the PD-1 receptor on T-cells, enabling the immune system to better recognize and attack cancer cells. It is approved for treating various types of cancer, including hepatocellular carcinoma, and is typically administered as an infusion every few weeks.

  • Relatlimab

    An innovative immunotherapy drug administered intravenously that targets the LAG-3 immune checkpoint protein. This monoclonal antibody helps activate T-cells in the immune system by blocking the LAG-3 pathway, which can enhance the body's natural ability to fight cancer cells. It is being studied in clinical trials for various cancer types, including hepatocellular carcinoma, often in combination with other immunotherapy agents.

  • Bevacizumab

    An intravenously administered targeted therapy that belongs to the class of anti-angiogenic agents. This monoclonal antibody works by blocking the formation of new blood vessels that feed tumors by targeting vascular endothelial growth factor (VEGF). It is approved for treating multiple types of cancer, including hepatocellular carcinoma, and is typically given as an infusion in combination with other cancer treatments.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-510649-33-00Protocol codeCA224-106Estimated enrolment162 patientsSponsorBristol Myers Squibb International Corporation

sourced from the EU Clinical Trials Register and site verification

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