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Study on Patient Preference for Nivolumab and Relatlimab Administration Methods in Melanoma Patients

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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 Melanoma, a type of skin cancer. The study will explore different ways of administering treatments that include a combination of medications called Nivolumab and Relatlimab. These medications are given either as a solution for injection under the skin (subcutaneous) or as a solution for infusion into a vein (intravenous). The trial will also compare these methods for another medication, Nivolumab, which is used alone.

The purpose of the study is to understand which method of receiving the medication participants prefer. Participants will receive the treatments in both ways and will be asked about their preferences. The study will also monitor any side effects or unusual results from laboratory tests during the trial. This will help researchers learn more about how people feel about the different ways of receiving these treatments.

The study will involve participants who have either advanced melanoma that has spread to other parts of the body (metastatic melanoma) or melanoma that has been surgically removed (resected melanoma). The trial aims to gather information over several years to ensure a comprehensive understanding of patient preferences and the safety of the treatments.

The research process

The trial runs in 7 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 may include a review of your medical history, a physical examination, and laboratory tests to ensure you meet the study criteria.

  3. Step 3

    Treatment phase 1

    You will receive the first treatment, which involves the administration of nivolumab and relatlimab as a fixed-dose combination. This will be given as an intravenous infusion (IV).

    The dosage for this phase is 960 mg of nivolumab and 320 mg of relatlimab per vial. The frequency and duration of administration will be explained to you by the study team.

  4. Step 4

    Treatment phase 2

    In the second phase, you will receive the same medications, nivolumab and relatlimab, but this time as a subcutaneous injection (SC).

    The dosage remains the same, and the study team will provide details on the frequency and duration of this administration.

  5. Step 5

    Preference assessment

    After completing both treatment phases, you will be asked to express your preference for either the intravenous (IV) or subcutaneous (SC) method of administration.

    This feedback is crucial for understanding patient preferences in treatment delivery.

  6. Step 6

    Monitoring and follow-up

    Throughout the study, you will be monitored for any side effects or changes in your health. Regular follow-up visits will be scheduled to ensure your safety and to collect necessary data.

    Laboratory tests may be conducted to check for any abnormalities.

  7. Step 7

    Study completion

    Upon completion of the study, a final assessment will be conducted. This may include a physical examination and laboratory tests to evaluate your overall health.

    You will be informed about the study's findings and any implications for your future treatment.

Who can join the trial?

7 criteria

  • Participants must be 18 years of age or older.
  • Both men and women can participate, but women must not be pregnant or breastfeeding.
  • Participants must have melanoma, which is a type of skin cancer.
  • Participants with metastatic melanoma (cancer that has spread to other parts of the body) should not have had previous treatment for their cancer.
  • Participants with resected melanoma (cancer that has been completely removed by surgery) must have had the surgery no later than 12 weeks before the start of treatment and must be confirmed free of disease.
  • Participants must have a low level of disability, meaning they can perform daily activities with little or no help.
  • Participants must have cancer that is considered advanced for metastatic melanoma or at risk for becoming advanced (intermediate) or advanced for resected melanoma.

Who cannot join the trial?

3 criteria

  • Patients who do not have melanoma cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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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 if patients prefer receiving it through a needle under the skin (subcutaneous) or directly into a vein (intravenous).

  • 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. In this study, it is combined with nivolumab in a fixed-dose and is being tested to see if patients prefer the combination to be given under the skin or into a vein.

What is already known about the treatment

Nivolumab + Relatlimab Fixed-dose Combination – This medication is being studied in a clinical trial to determine patient preference for its administration either as a subcutaneous (under the skin) injection or an intravenous (into the vein) infusion in individuals with melanoma, a type of skin cancer. Currently, this combination is under investigation, and its status in medical literature is focused on understanding patient comfort and convenience. The main therapeutic indication for this combination is melanoma. At the molecular level, nivolumab works by blocking a protein called PD-1, which helps the immune system attack cancer cells, while relatlimab targets another protein called LAG-3, enhancing the immune response against cancer. This combination falls under the pharmacological classification of immune checkpoint inhibitors, which are drugs that help the immune system recognize and fight cancer cells.

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, typically with irregular borders and multiple colors. 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 develop on any skin surface but is more common in areas exposed to the sun, such as the back, legs, arms, and face. Melanoma can also occur in the eyes and, rarely, in internal organs. Early detection is crucial, as the disease can be more effectively managed before it spreads extensively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504515-33-00Protocol codeCA224-1044Estimated enrolment145 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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