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Study Comparing Subcutaneous and Intravenous Nivolumab and Relatlimab for Patients with Untreated Metastatic or Unresectable Melanoma

Verified siteInvestigationalNo 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 metastatic or unresectable melanoma, which means the cancer has spread to other parts of the body or cannot be removed with surgery. The study is testing a treatment that combines two medications, nivolumab and relatlimab. These medications are given in two different ways: one is a solution for infusion, which is administered directly into a vein, and the other is a solution for injection, which is given under the skin. The purpose of the study is to see if the amount of these medications in the body is the same when given under the skin compared to when given into a vein.

Participants in the study will receive either the intravenous or subcutaneous form of the medication. The study will monitor how the body absorbs the medications and will also look at how well the cancer responds to the treatment. This includes checking if the cancer decreases in size or disappears after treatment. The study will take place over a period of time, and participants will be closely observed to ensure their safety and to gather information about the effectiveness of the treatment.

The trial is open to individuals who have not received prior systemic treatment for their melanoma, except for certain previous therapies if any side effects have stabilized. The study aims to provide valuable information on whether the subcutaneous method of administering the medications is as effective as the intravenous method, potentially offering a more convenient option for patients in the future.

The research process

The trial runs in 6 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, you will be informed about the trial's purpose, procedures, and your role as a participant. You will be asked to provide consent to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes checking your age, weight, and performance status, which measures your ability to perform daily activities.

    Your medical history will be reviewed to ensure you have not received prior systemic anticancer therapy, except for certain previous treatments if any side effects have stabilized.

  3. Step 3

    Treatment assignment

    You will be randomly assigned to receive either the subcutaneous (under the skin) or intravenous (into the vein) form of the study drugs, nivolumab and relatlimab.

  4. Step 4

    Treatment administration

    If assigned to the intravenous group, you will receive a solution for infusion containing nivolumab 240 mg and relatlimab 80 mg per vial.

    If assigned to the subcutaneous group, you will receive an injection containing nivolumab 960 mg, relatlimab 320 mg, and additional components per vial.

    The frequency and duration of administration will be explained to you by the study team.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, your health and response to the treatment will be closely monitored. This includes regular check-ups and tests to measure the amount of the study drug in your body and assess the response of your melanoma.

    The study aims to determine if the subcutaneous administration is as effective as the intravenous method.

  6. Step 6

    Completion of the study

    Upon completion of the study, you will undergo a final assessment to evaluate your overall health and the effects of the treatment.

    The study is expected to conclude by August 2026, and you will be informed of any relevant findings or follow-up actions.

Who can join the trial?

5 criteria

  • Must be 12 years of age or older. If you are between 12 and 18 years old, you must weigh at least 40 kg (about 88 pounds).
  • Must have an ECOG performance status of 0 or 1 or a Lansky Performance Score of 80% or higher if you are between 12 and 18 years old. This score describes your ability to take care of yourself and do daily activities like walking or working.
  • Must have a confirmed diagnosis of Stage III or Stage IV melanoma. Stage III means the cancer cannot be removed with surgery, and Stage IV means the cancer has spread to other parts of the body.
  • Must not have received any prior systemic anticancer therapy, except for certain previous treatments for melanoma if all side effects have returned to normal or stabilized.
  • Must have measurable disease according to RECIST v1.1, which is a standard way to measure how well a cancer patient responds to treatment.

Who cannot join the trial?

6 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 certain other medical conditions may not be eligible. Please discuss your medical history with the study team.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are unable to give informed consent are not eligible.
  • Patients who are participating in another clinical trial may not be eligible.
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Investigated drugs

  • Nivolumab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is being tested to see how well it works when given under the skin compared to directly into a vein for treating melanoma, a type of skin cancer.

  • Relatlimab

    is another immune checkpoint inhibitor that is used in combination with nivolumab. It helps to further enhance the immune system's ability to fight cancer by targeting a different pathway than nivolumab. This combination is being studied to determine if it is as effective when administered under the skin as it is when given intravenously for patients with melanoma.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered either as an injection under the skin (subcutaneous) or directly into a vein (intravenous). It is currently being studied in clinical trials for its effectiveness in treating previously untreated metastatic or unresectable melanoma, a type of skin cancer. Nivolumab works by blocking a protein that prevents the immune system from attacking cancer cells, thereby helping the body’s immune system to fight the cancer. It is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system recognize and destroy cancer cells.

  • Relatlimab

    Relatlimab is given in combination with nivolumab, either as a subcutaneous injection or intravenously. It is being evaluated in clinical trials for its role in treating previously untreated metastatic or unresectable melanoma. Relatlimab functions by targeting a specific protein on immune cells, enhancing the immune system's ability to detect and attack cancer cells. It belongs to the class of drugs known as immune checkpoint inhibitors, which are designed to boost the immune response against cancer.

Investigated diseases

Melanoma – Melanoma is a type of skin cancer that begins in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. It often appears as a new mole or a change in an existing mole, and it can be identified by its irregular shape, multiple colors, and larger size. As melanoma progresses, it can grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. The disease can be classified as metastatic when it spreads beyond the original site to distant organs. Unresectable melanoma refers to a stage where the cancer cannot be surgically removed due to its location or extent. Early detection and monitoring of changes in the skin are crucial for managing melanoma.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500967-11-00Protocol codeCA224-127Estimated enrolment819 patientsSponsorBristol-Myers Squibb Services Unlimited Company

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