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Study of Nivolumab and Relatlimab for Patients with Stage III-IV Melanoma After Surgery

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 the treatment of Stage III-IV Melanoma, a type of skin cancer that has been completely removed through surgery. The study is comparing two treatments: a combination of two medications, Nivolumab and Relatlimab, and a single medication, Nivolumab alone. These medications are given as a solution for infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to see how effective the combination treatment is compared to the single medication in preventing the return of melanoma after surgery. Participants in the study will receive either the combination of Nivolumab and Relatlimab or Nivolumab alone. Some participants may receive a placebo, which looks like the treatment but does not contain the active medication. The study will last for up to 12 months, during which participants will be monitored regularly to check for any signs of the cancer returning and to assess their overall health.

Throughout the study, participants will undergo regular check-ups and tests to monitor their health and the effectiveness of the treatment. The study aims to provide valuable information on whether the combination of Nivolumab and Relatlimab offers better protection against the return of melanoma compared to Nivolumab alone. This research could help improve future treatment options for people with this type of skin 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, eligibility is confirmed based on specific criteria, including a diagnosis of Stage III or Stage IV melanoma that has been completely removed through surgery.

    A complete physical examination and imaging studies are conducted to ensure the absence of disease.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving a combination of nivolumab and relatlimab, and the other receiving nivolumab alone.

    This process is double-blind, meaning neither the participants nor the researchers know which treatment is being administered to each participant.

  3. Step 3

    Treatment administration

    The treatment involves intravenous administration of the medication. Nivolumab is given as a 10 mg/mL concentrate for infusion, while the combination treatment includes nivolumab 240 mg and relatlimab 80 mg per vial.

    The frequency and duration of the treatment are determined by the study protocol and are administered under medical supervision.

  4. Step 4

    Monitoring and follow-up

    Participants are regularly monitored for any side effects or adverse reactions to the treatment. This includes routine laboratory tests and assessments by healthcare professionals.

    The study aims to measure the time until any recurrence of melanoma or death, as well as overall survival and other health outcomes.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by November 2029. Participants will continue to be monitored until the study's end date or until they meet specific criteria for withdrawal from the study.

Who can join the trial?

5 criteria

  • Participants must have been diagnosed with either Stage IIIA (with a tumor larger than 1 mm in a lymph node), IIIB, IIIC, IIID, or Stage IV melanoma. Melanoma is a type of skin cancer. The cancer must be completely removed by surgery, with no remaining disease, and the edges of the removed tissue must be free of cancer cells. All types of melanoma are allowed, except for melanoma of the eye. However, melanoma of the conjunctiva (a part of the eye) is considered mucosal melanoma and is allowed.
  • Participants must have no signs of the disease, confirmed by a full physical examination within 14 days before starting the study and imaging tests within 35 days before starting the study.
  • Tumor tissue from the surgery or biopsy must be collected within 90 days before starting the study and sent to a central laboratory, preferably before starting the study. A pathology report, which is a document that describes the characteristics of the tissue, must be included.
  • Participants must be at least 12 years old at the time of signing the consent form. However, if local rules do not allow people under 18 to participate, then only those 18 and older can join.
  • Participants who are 18 years or older must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale that measures how well a person can perform daily activities. A score of 0 means fully active, and 1 means some restrictions but can still do light work. Participants between 12 and 17 years old must have a Lansky/Karnofsky performance score of 80% or higher, which also measures the ability to perform daily activities.

Who cannot join the trial?

1 criterion

  • Participants who have not had their Stage III or Stage IV melanoma completely removed by surgery cannot participate.
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Investigated drugs

  • Nivolumab

    is a type of immunotherapy used in this trial. It works by helping the immune system recognize and attack cancer cells. It is used after the complete surgical removal of melanoma to help prevent the cancer from coming back.

  • Relatlimab

    is another immunotherapy drug being tested in combination with Nivolumab. It is designed to enhance the immune response against cancer cells. In this trial, it is used together with Nivolumab to see if the combination is more effective than Nivolumab alone in preventing the return of melanoma after surgery.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently approved and widely used in the treatment of various cancers, including melanoma, and is well-documented in medical literature. The main therapeutic indication for nivolumab in this trial is for patients with completely resected Stage III or IV melanoma. At the molecular level, nivolumab works by blocking the PD-1 protein on immune cells, enhancing the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor.

  • Relatlimab

    Relatlimab is also administered intravenously, often in combination with other medications like nivolumab. It is under investigation in clinical trials and is not yet as established in medical literature as nivolumab. The primary therapeutic indication in this trial is for patients with completely resected Stage III or IV melanoma. Relatlimab functions by targeting the LAG-3 protein on immune cells, which helps to further stimulate the immune system to attack cancer cells. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Melanoma – Melanoma is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. It is characterized by the uncontrolled growth of these cells, often appearing as a new or changing mole on the skin. Melanoma can progress from a localized stage, where it is confined to the skin, to more advanced stages where it spreads to other parts of the body, such as lymph nodes or distant organs. The disease is categorized into stages, with Stage III indicating regional spread and Stage IV indicating distant metastasis. Early detection and complete surgical removal of the tumor can be crucial in managing the disease. However, even after complete resection, there is a risk of recurrence, which can occur locally, regionally, or at distant sites.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507688-20-00Protocol codeCA224-098Estimated enrolment1 350 patientsSponsorBristol Myers Squibb International Corporation

sourced from the EU Clinical Trials Register and site verification

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