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Study Comparing Relatlimab and Nivolumab Combination vs. Nivolumab Alone for Patients with Advanced Melanoma

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 skin cancer called melanoma, specifically in cases where the cancer has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). The study is investigating the effectiveness of two treatments: nivolumab, which is already used to treat melanoma, and a combination of relatlimab and nivolumab. Nivolumab is a medication that helps the immune system fight cancer cells, and relatlimab is being studied for its potential to enhance this effect.

The purpose of the study is to compare how well patients do when treated with the combination of relatlimab and nivolumab versus nivolumab alone. Participants in the study will receive either the combination treatment or nivolumab by itself. The study is designed to be "double-blind," meaning neither the participants nor the researchers know who is receiving which treatment, to ensure unbiased results. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments being studied.

Throughout the study, participants will receive their assigned treatment through an infusion, which is a way of delivering medication directly into the bloodstream. The study will monitor how long participants live without their cancer getting worse, known as progression-free survival. Other aspects, such as overall survival and the response of the cancer to the treatment, will also be observed. The study aims to provide valuable information on whether the combination of relatlimab and nivolumab offers better outcomes for patients with advanced melanoma compared to nivolumab alone.

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. This includes having Stage III (unresectable) or Stage IV melanoma and not having received prior systemic anticancer therapy for this condition.

    Tumor tissue from an unresectable or metastatic site is required for analysis.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to receive either nivolumab alone or a combination of relatlimab and nivolumab.

    The study is double-blind, meaning neither the participant nor the healthcare provider knows which treatment is being administered.

  3. Step 3

    Treatment administration

    The medications are administered as a solution for infusion through an intravenous route.

    For the combination treatment, nivolumab is given at a dose of 240 mg and relatlimab at 80 mg per vial.

  4. Step 4

    Monitoring and assessments

    Progression-free survival (PFS) is assessed to determine how long the disease does not worsen during the treatment.

    Regular assessments are conducted by a Blinded Independent Central Review (BICR) to evaluate the response to treatment.

  5. Step 5

    End of treatment

    The study aims to continue until December 16, 2025, or until specific endpoints are reached.

    Participants are monitored for overall survival (OS) and other outcomes such as the duration of response and any adverse events.

Who can join the trial?

6 criteria

  • Participants must have a confirmed diagnosis of **Stage III (unresectable)** or **Stage IV melanoma**. This means the cancer is advanced and cannot be removed by surgery.
  • Participants must not have received any previous treatments that affect the whole body for their **unresectable** or **metastatic melanoma**. This means they haven't had treatments like chemotherapy or immunotherapy for this type of cancer.
  • A sample of the tumor from a site that cannot be removed or has spread must be provided for special tests called **biomarker analyses**. These tests help understand the cancer better.
  • Both men and women can participate in the study.
  • The study includes people from different age groups, including adults and older adults.
  • The study may include people who are considered part of a **vulnerable population**. This term refers to groups who might need special protection or care.

Who cannot join the trial?

10 criteria

  • Patients who have already received treatment for their melanoma cannot participate.
  • Patients with melanoma that can be surgically removed are not eligible.
  • Patients with other serious health conditions that might interfere with the study are excluded.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Patients who are unable to follow the study procedures or attend required visits are not eligible.
  • Patients with a history of other cancers, unless they have been in remission for a certain period, are excluded.
  • Patients with certain infections, like HIV or hepatitis, cannot participate.
  • Patients who have had an organ transplant are not eligible.
  • Patients taking medications that might interfere with the study treatment are excluded.
  • Patients with known allergies to the study drugs cannot participate.
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Investigated drugs

  • Relatlimab

    is an experimental medication being studied for its potential to treat melanoma, a type of skin cancer. It is being tested in combination with another medication to see if it can help slow down the progression of the disease in patients who have not received prior treatment.

  • Nivolumab

    is a medication used to treat various types of cancer, including melanoma. It works by helping the immune system recognize and attack cancer cells. In this trial, it is being used both alone and in combination with another medication to evaluate its effectiveness in treating melanoma.

What is already known about the treatment

  • Relatlimab

    This medication is administered intravenously and is currently being studied in combination with nivolumab for the treatment of previously untreated metastatic or unresectable melanoma. It is in the clinical trial phase, with ongoing research to determine its effectiveness and safety. Relatlimab works by targeting specific proteins on immune cells, enhancing the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system recognize and attack cancer cells more effectively.

  • Nivolumab

    This medication is also administered intravenously and is used in the treatment of various cancers, including melanoma. It is well-established in medical literature and is approved for use in several cancer types. Nivolumab functions by blocking a protein on immune cells, allowing them to better detect and destroy cancer cells. It belongs to the class of immune checkpoint inhibitors, which are designed to boost the immune system's ability to fight cancer.

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 spread to other parts of the body if not detected early, making it more challenging to treat. The disease progresses by invading nearby tissues and potentially spreading to distant organs through the lymphatic system or bloodstream. It is more common in individuals with fair skin, a history of sunburns, or excessive UV exposure. Early detection and monitoring of skin changes are crucial in managing melanoma effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-510913-13-00Protocol codeCA224-047Estimated enrolment1 000 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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