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Study of Relatlimab and Nivolumab for Patients with Advanced Liver Cancer Who Have Not Received Immunotherapy After Tyrosine Kinase Inhibitor 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 Advanced Hepatocellular Carcinoma. The study is investigating the effects of two medications, Relatlimab and Nivolumab, which are given together to participants who have not previously received immuno-oncology therapy. These participants have already been treated with medications called tyrosine kinase inhibitors, which are used to slow down the growth of cancer cells.

The purpose of the study is to evaluate how effective the combination of Relatlimab and Nivolumab is compared to using Nivolumab alone. Participants will receive these medications through an intravenous method, which means they are administered directly into the bloodstream. The study will monitor the participants' response to the treatment over time, looking at how well the cancer is controlled and how long any positive effects last.

Throughout the study, researchers will also keep track of any side effects or changes in health that participants experience. This includes monitoring for any serious health issues and changes in routine blood and urine tests. The study aims to provide valuable information on the potential benefits and risks of using these medications together for treating advanced liver cancer.

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

    Joining the study

    Upon joining the study, participants will be randomly assigned to receive either a combination of relatlimab and nivolumab or nivolumab alone. This is to evaluate the effectiveness of the combination therapy compared to the single therapy.

  2. Step 2

    Treatment administration

    Participants will receive the medications through an intravenous (IV) infusion. This means the medication is given directly into a vein using a needle.

    The dosage and frequency of the medication will be determined by the study protocol and will be explained by the healthcare team.

  3. Step 3

    Monitoring and assessments

    Regular monitoring will be conducted to assess the participant's response to the treatment. This includes physical exams, blood tests, and imaging studies to evaluate the cancer's response.

    Participants will be monitored for any side effects or adverse reactions to the treatment. Any significant changes in health will be recorded and addressed by the healthcare team.

  4. Step 4

    End of treatment

    The treatment will continue until the participant completes the study, experiences unacceptable side effects, or the cancer progresses.

    At the end of the treatment, a final assessment will be conducted to evaluate the overall response to the therapy.

  5. Step 5

    Follow-up

    After completing the treatment, participants will have follow-up visits to monitor their health and any long-term effects of the treatment.

    These visits will help gather information on the overall survival and long-term outcomes of the participants.

Who can join the trial?

6 criteria

  • Participants must be 18 years or older.
  • Participants must have a confirmed diagnosis of advanced or metastatic hepatocellular carcinoma (HCC), which means liver cancer that has spread.
  • Participants must provide a tumor tissue sample that shows a measurable level of LAG-3 expression. This is a specific protein that needs to be present for the study.
  • Participants must have shown cancer progression after one or two treatments with TKI therapies (a type of cancer treatment) and must not have been treated with IO agents (immune-oncology treatments) before.
  • Participants must have a Child-Pugh score of 5 or 6 points, which indicates a certain level of liver function.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means they are fully active or have some symptoms but do not require bed rest.

Who cannot join the trial?

3 criteria

  • Patients who have not been diagnosed with Advanced Hepatocellular Carcinoma cannot participate.
  • Patients who have already received IO therapy (a type of immune therapy) are not eligible.
  • Patients who have not been treated with TKI therapy (a type of targeted cancer therapy) before are excluded.
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Investigated drugs

  • Relatlimab

    is a medication that is being studied for its potential to help the immune system fight cancer. It works by blocking a specific protein that can slow down the immune response. By blocking this protein, relatlimab may help the body's immune system attack cancer cells more effectively. In this trial, it is being tested in combination with another medication to see if it can improve treatment outcomes for people with advanced liver cancer.

  • Nivolumab

    is a medication that helps the immune system recognize and attack cancer cells. It works by blocking a protein that prevents the immune system from attacking cancer cells. This can help the immune system to better identify and destroy cancer cells. In this trial, nivolumab is being used both on its own and in combination with another medication to see how well it works for people with advanced liver cancer who have not been treated with immune therapy before but have tried other cancer treatments.

What is already known about the treatment

  • Relatlimab

    Relatlimab is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating advanced liver cancer, specifically hepatocellular carcinoma, in patients who have not received immune therapy but have previously been treated with tyrosine kinase inhibitors. The medication works by targeting and blocking a specific protein on immune cells, which helps the immune system recognize and attack cancer cells more effectively. Relatlimab is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

  • Nivolumab

    Nivolumab is also given as an intravenous infusion, allowing it to enter the bloodstream directly. It is an established medication in the treatment of various cancers and is being evaluated in combination with relatlimab for advanced liver cancer in patients who have not undergone immune therapy but have been treated with tyrosine kinase inhibitors. Nivolumab functions by inhibiting a protein that prevents immune cells from attacking cancer cells, thereby enhancing the body's immune response against the tumor. It belongs to the pharmacological class of immune checkpoint inhibitors, which are designed to boost the immune system's ability to combat cancer.

Investigated diseases

Advanced Hepatocellular Carcinoma – Advanced Hepatocellular Carcinoma is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It is characterized by the uncontrolled growth of abnormal cells in the liver, leading to the formation of a tumor. As the disease progresses, the tumor may grow larger and spread to other parts of the liver or to other organs in the body. Symptoms may include abdominal pain, weight loss, and jaundice, which is a yellowing of the skin and eyes. The disease can cause liver dysfunction as it advances, affecting the liver's ability to perform its normal functions. Over time, the cancer may invade blood vessels and other structures, complicating the condition further.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503519-13-00Protocol codeCA224-073Estimated enrolment250 patientsSponsorBristol Myers Squibb International Corporation

sourced from the EU Clinical Trials Register and site verification

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