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Study of Nivolumab and Relatlimab for Adults with Advanced or Metastatic Soft-Tissue Sarcoma

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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 cancer called soft-tissue sarcoma, which is a cancer that begins in the tissues that connect, support, or surround other structures and organs of the body. The study is looking at patients with advanced or metastatic forms of this disease, meaning the cancer has spread to other parts of the body or cannot be removed by surgery. The trial is testing a combination of two medications: Nivolumab and Relatlimab. Nivolumab, also known by its code name BMS936558, is a type of medication called a monoclonal antibody, which helps the immune system recognize and attack cancer cells. Relatlimab, also known as BMS-986016, is another monoclonal antibody that targets a specific protein on immune cells to enhance the body's immune response against cancer.

The purpose of this study is to evaluate how well the combination of Nivolumab and Relatlimab works in controlling the cancer over a period of six months. Participants in the study will receive these medications through an intravenous infusion, which means the drugs are given directly into a vein. The study will monitor the participants' response to the treatment, looking for signs that the cancer is shrinking, staying the same, or growing. The trial will also assess the safety of the treatment combination and any side effects that may occur.

Throughout the study, participants will undergo regular medical check-ups and imaging tests, such as MRI or CT scans, to track the progress of their cancer. These tests help doctors determine how the cancer is responding to the treatment. The study aims to provide valuable information on the effectiveness of combining Nivolumab and Relatlimab for treating advanced or metastatic soft-tissue sarcoma, potentially offering new hope for patients with this challenging condition.

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, eligibility is confirmed based on specific criteria such as age, medical history, and current health status.

    A negative pregnancy test is required for women of childbearing potential, and both men and women must agree to use contraception during and after the study.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of two medications: nivolumab and relatlimab.

    Both medications are given as an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

    The dosage and frequency of administration are determined by the study protocol and are monitored by healthcare professionals.

  3. Step 3

    Treatment monitoring

    Regular monitoring is conducted to assess the response to treatment and to check for any side effects.

    This includes blood tests, imaging studies, and other assessments as required by the study protocol.

  4. Step 4

    Progress evaluation

    The primary goal is to evaluate the antitumor activity of the treatment combination over a period of six months.

    Progress is measured using specific criteria to determine if the disease is stable, has improved, or has progressed.

  5. Step 5

    Completion of treatment

    The study is expected to continue until March 2026, with individual participation duration varying based on response and other factors.

    Upon completion, final assessments are conducted to evaluate the overall effectiveness and safety of the treatment.

Who can join the trial?

21 criteria

  • Participants must have a type of cancer called soft tissue sarcoma, confirmed by a specific medical review.
  • Participants must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • The disease must be measurable according to specific criteria called RECIST v1.1, with at least one tumor that is 10 mm or larger.
  • Participants should have a life expectancy of more than 3 months.
  • Participants should not have any symptoms of disease in the central nervous system (brain and spinal cord).
  • Participants should not be using glucocorticoids (a type of steroid medication) in doses higher than 10 mg per day.
  • Participants must have adequate blood, kidney, liver, and metabolic function, with specific levels for various tests like hemoglobin, liver enzymes, and creatinine.
  • The heart's pumping ability, called left ventricular ejection fraction (LVEF), must be 50% or higher.
  • Participants should not have had any other cancer diagnosed or treated in the last 2 years, except for certain types that are considered low risk.
  • Participants must have stopped any previous cancer treatments like chemotherapy or radiotherapy at least 3 weeks before starting the study.
  • Participants must have recovered from any side effects of previous treatments to a mild level, except for hair loss or mild nerve pain.
  • Participants must have specific structures in their tumor called mature tertiary lymphoid structures (TLS), confirmed by a central review.
  • Women who can have children must have a negative pregnancy test before starting the study and agree to use birth control during and after the study. Men must also agree to use birth control during and after the study.
  • Participants must sign a consent form agreeing to participate in the study.
  • Participants must have social security coverage as required by French law.
  • Participants must provide a sample of their tumor tissue for research purposes.
  • Participants must have advanced disease that cannot be surgically removed or has spread to other parts of the body.
  • Participants must show disease progression according to specific criteria unless they have not received prior treatment for advanced disease.
  • Participants must have a tumor that can be biopsied for research purposes.
  • Participants must not have had more than two previous treatments for advanced or metastatic disease.
  • Participants must be at least 18 years old.

Who cannot join the trial?

7 criteria

  • Participants who have a different type of cancer than advanced or metastatic soft-tissue sarcoma.
  • Participants who have had previous treatment with the study drugs, Nivolumab or Relatlimab.
  • Participants with a history of severe allergic reactions to any of the study drugs.
  • Participants with active infections that require treatment.
  • Participants with other serious medical conditions that could interfere with the study.
  • Participants who are pregnant or breastfeeding.
  • Participants who are unable to follow the study procedures or attend study visits.
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Investigated drugs

  • Nivolumab

    is a medication used in this trial to help the body's immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells, allowing the immune system to better target and destroy these cells.

  • Relatlimab

    is another medication used in combination with Nivolumab in this trial. It also helps the immune system fight cancer by targeting a different protein that can inhibit immune responses. By blocking this protein, Relatlimab helps enhance the immune system's ability to attack cancer cells.

What is already known about the treatment

  • Nivolumab

    This medication is administered intravenously and is currently being studied in combination with relatlimab for treating advanced or metastatic soft-tissue sarcoma. It is an approved immunotherapy drug that works by blocking a protein called PD-1 on immune cells, enhancing the body's immune response against cancer cells. Nivolumab is classified as a checkpoint inhibitor and is widely recognized in medical literature for its role in treating various cancers.

  • Relatlimab

    Administered intravenously, relatlimab is being investigated alongside nivolumab for its potential to treat advanced or metastatic soft-tissue sarcoma. It functions by targeting the LAG-3 protein on immune cells, which helps to boost the immune system's ability to fight cancer. Relatlimab is classified as a checkpoint inhibitor and is currently under clinical evaluation to determine its effectiveness and safety in combination therapies.

Investigated diseases

Soft-Tissue Sarcoma – Soft-tissue sarcoma is a type of cancer that begins in the tissues that connect, support, or surround other structures and organs of the body. These tissues include muscle, fat, blood vessels, nerves, tendons, and the lining of the joints. The disease can occur in any part of the body but is most commonly found in the arms, legs, and trunk. As it progresses, the tumor may grow and invade nearby tissues, potentially spreading to other parts of the body. Symptoms often depend on the location and size of the tumor and may include a noticeable lump or swelling. The progression of the disease can vary significantly among individuals, with some experiencing slow growth and others facing more rapid advancement.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509495-42-00Protocol codeIB 2019-03Estimated enrolment67 patientsSponsorInstitut Bergonie

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).