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Study of Relatlimab, Nivolumab, and Drug Combination for Patients with Advanced Cancer

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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 treatments for advanced malignant tumors, which are types of cancer that have spread or are difficult to remove surgically. The study involves testing combinations of different medications to see how they work together in treating these cancers. The medications being tested include Relatlimab, which is an anti-LAG-3 monoclonal antibody, Nivolumab, an anti-PD-1 monoclonal antibody, Ipilimumab, an anti-CTLA-4 monoclonal antibody, and Linrodostat Mesylate, an IDO1 inhibitor. Some of these medications are given through an injection into a vein, while others are taken as tablets.

The purpose of the study is to determine the safety and tolerability of these medication combinations and to observe their effects on the tumors. Participants will receive different combinations of these medications, and their health will be monitored closely to identify any side effects or changes in their condition. The study aims to find out how well these combinations can control the disease and how long any positive effects last.

Throughout the study, participants will undergo regular health checks and tests to track their progress. The study will help researchers understand more about how these medications work together and their potential benefits for people with advanced cancers. The trial is expected to continue until 2026, providing valuable information on the effectiveness and safety of these treatment combinations.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Eligibility criteria include confirmation of an incurable solid malignancy that is advanced, availability of tumor tissue for analysis, and a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale.

  2. Step 2

    Treatment phase 1

    The first phase of treatment involves the administration of relatlimab and nivolumab intravenously. These are monoclonal antibodies designed to help the immune system fight cancer.

    Additionally, linrodostat mesylate is taken orally. This is an IDO1 inhibitor, which may help in reducing tumor growth.

    The dosage and frequency of administration are determined by the study protocol and are monitored closely by the medical team.

  3. Step 3

    Treatment phase 2

    In the second phase, the treatment may include a combination of relatlimab, nivolumab, and ipilimumab. Ipilimumab is another monoclonal antibody administered intravenously.

    The combination aims to enhance the immune response against cancer cells.

    The duration and specific regimen are based on individual response and tolerance.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to assess safety and effectiveness. This includes clinical laboratory tests and imaging studies.

    Adverse events and any abnormalities are recorded to ensure participant safety.

    The response to treatment is evaluated using criteria such as Objective Response Rate and Disease Control Rate.

  5. Step 5

    End of trial

    The trial is estimated to conclude by November 2026. At the end of the trial, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

    Participants may be offered follow-up care or additional treatment options based on the results.

Who can join the trial?

6 criteria

  • The patient must have a confirmed diagnosis of an incurable solid cancer that is **advanced**, meaning it has spread to other parts of the body or cannot be removed by surgery. The cancer must be measurable according to specific guidelines called **RECIST v1.1**.
  • The patient must have available **tumor tissue** for testing. This means a sample of the cancer is needed for further analysis.
  • The patient must have an **ECOG Performance Status** of 0 or 1. This is a scale used to assess how well a patient can perform daily activities. A status of 0 means the patient is fully active, while 1 means the patient is restricted in physically strenuous activity but can carry out light work.
  • The patient must be within the age range of adults, which typically means 18 years or older.
  • Both **male** and **female** patients are eligible to participate.
  • The study may include individuals considered part of a **vulnerable population**, which can mean people who might need special protection or consideration.

Who cannot join the trial?

4 criteria

  • Patients with certain types of **advanced malignant tumors** cannot participate. **Advanced malignant tumors** are cancers that have spread to other parts of the body and are in a more severe stage.
  • Patients who have not met the age requirements for the study cannot participate. The study is open to specific age groups only.
  • Patients who are part of a vulnerable population may not be eligible. **Vulnerable populations** include groups that may need special protection, such as children, pregnant women, or those with certain disabilities.
  • Patients who do not meet the safety and health criteria set by the study cannot participate. This includes having certain health conditions or taking medications that might interfere with the study.
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Investigated drugs

  • Relatlimab

    is a monoclonal antibody that targets LAG-3, a protein involved in regulating the immune system. By blocking LAG-3, relatlimab may help the immune system recognize and attack cancer cells more effectively. In this trial, it is being tested in combination with other medications to treat advanced malignant tumors.

  • Nivolumab

    is a monoclonal antibody that targets PD-1, a protein on the surface of immune cells. By blocking PD-1, nivolumab can enhance the immune system's ability to fight cancer. It is used in this trial in combination with other medications to treat advanced malignant tumors.

  • BMS-986205

    is an IDO1 inhibitor, which means it blocks the activity of the IDO1 enzyme. This enzyme can suppress the immune system, so by inhibiting it, BMS-986205 may help the immune system attack cancer cells. It is being tested in combination with other medications in this trial for advanced malignant tumors.

  • Ipilimumab

    is a monoclonal antibody that targets CTLA-4, another protein that can inhibit the immune system. By blocking CTLA-4, ipilimumab may enhance the immune response against cancer cells. In this trial, it is used in combination with other medications to treat advanced malignant tumors.

What is already known about the treatment

  • Relatlimab

    This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating advanced malignant tumors. It is a monoclonal antibody that targets the LAG-3 protein, which plays a role in regulating the immune system. By blocking LAG-3, relatlimab may enhance the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor and is being tested in combination with other similar medications to assess its safety and effectiveness.

  • Nivolumab

    Administered intravenously, nivolumab is an established medication used in the treatment of various cancers, including advanced malignant tumors. It works by inhibiting the PD-1 protein on immune cells, thereby boosting the immune system's ability to attack cancer cells. Nivolumab is classified as an immune checkpoint inhibitor and is widely recognized in medical literature for its role in cancer therapy.

  • BMS-986205

    This medication is taken orally and is currently under investigation in clinical trials for its potential to treat advanced malignant tumors. It functions as an IDO1 inhibitor, which may help in reducing the immune suppression caused by tumors, thereby enhancing the immune response. BMS-986205 is part of a class of drugs known as enzyme inhibitors and is being studied for its safety and effectiveness in combination with other cancer therapies.

  • Ipilimumab

    Administered intravenously, ipilimumab is a medication used in the treatment of certain cancers, including advanced malignant tumors. It targets the CTLA-4 protein on immune cells, helping to strengthen the immune system's response against cancer. Ipilimumab is classified as an immune checkpoint inhibitor and is well-documented in medical literature for its use in cancer treatment.

Investigated diseases

Advanced Malignant Tumors – These are cancers that have progressed to a stage where they have spread beyond their original site to other parts of the body. The disease is characterized by the uncontrolled growth of abnormal cells that can invade nearby tissues and organs. As the tumors advance, they may cause symptoms depending on their location and size, such as pain, fatigue, or weight loss. The progression of these tumors can vary widely, with some growing slowly over time, while others may spread rapidly. The complexity of advanced malignant tumors often requires a comprehensive approach to understand their behavior and impact on the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-508207-21-00Protocol codeCA224-048Estimated enrolment325 patientsSponsorBristol Myers Squibb International Corporation

sourced from the EU Clinical Trials Register and site verification

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