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Study on Nivolumab for Preventing Melanoma Recurrence in Patients with Completely Removed Stage IIB/C Melanoma

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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 Stage IIB/C melanoma. The study is investigating the effectiveness of a treatment called nivolumab, which is also known by its code name BMS-936558. Nivolumab is a type of medication that is given through an infusion, which means it is delivered directly into the bloodstream through a vein. The trial compares nivolumab to a placebo to see if it can help prevent the cancer from coming back after it has been completely removed by surgery.

The main goal of the study is to see how well nivolumab works in keeping the cancer from returning. Participants in the study will receive either nivolumab or a placebo after their melanoma has been surgically removed. The study will monitor participants over a period of time to check for any signs of the cancer returning. This will help researchers understand if nivolumab can provide better outcomes compared to not receiving the active treatment.

Throughout the study, participants will undergo regular check-ups and imaging tests, such as CT scans and MRI, to ensure there is no evidence of the disease. The study aims to provide valuable information on whether nivolumab can be an effective treatment option for preventing the recurrence of Stage IIB/C melanoma after surgery. The trial is expected to continue until 2027, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the medication nivolumab, and the other group will receive a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

  2. Step 2

    Treatment administration

    If you are in the group receiving nivolumab, you will be given a solution called OPDIVO at a concentration of 10 mg/mL. This will be administered through an intravenous infusion, which means it will be given directly into your vein.

    The frequency and duration of the administration will be determined by the study protocol, and you will be informed about the specific schedule.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, your health will be closely monitored. This includes regular check-ups, blood tests, and imaging studies to ensure your safety and to assess the effectiveness of the treatment.

    You will be required to attend scheduled visits to the clinic for these assessments.

  4. Step 4

    End of treatment

    The treatment phase will continue as per the study's timeline, which is estimated to conclude by June 2027. You will be informed about the end date of your participation based on when you joined the study.

    After the treatment phase, there may be additional follow-up visits to monitor your health and gather further data for the study.

Who can join the trial?

9 criteria

  • Participants must have been diagnosed with Stage IIB/C cutaneous melanoma, which means a specific type of skin cancer that has been completely removed by surgery with no remaining cancer cells at the edges of the removed tissue.
  • The complete surgical removal of the melanoma must have been done within 12 weeks before joining the study. If there are delays beyond 12 weeks due to unexpected reasons, this should be discussed with the study team.
  • Participants must have had a negative sentinel lymph node biopsy, which means a test showing that the first lymph node to which cancer is likely to spread does not have cancer cells. If this test could not be done or the lymph node was not found, the participant is not eligible.
  • Participants must be free of disease, confirmed by a full physical exam within 14 days and imaging tests (like CT or MRI scans) within 4 weeks before joining the study. These tests should show no signs of cancer in the body, including the brain.
  • Participants must not have received any treatment for melanoma other than the complete surgical removal of the melanoma.
  • Participants must have recovered well from any side effects or complications from the surgery before starting the study.
  • Participants must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can carry out light work.
  • Tumor tissue from the removed melanoma must be provided to the central laboratory before joining the study. If this is not possible, it should be discussed with the study team.
  • Participants can be of any gender.

Who cannot join the trial?

4 criteria

  • Patients who have not had their Stage IIb/c melanoma completely removed cannot participate.
  • Patients with any signs of the disease still present are not eligible.
  • Patients who are not within the specified age range for the study cannot join.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible.
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Investigated drugs

Nivolumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, nivolumab is being tested to see if it can help prevent the return of melanoma, a type of skin cancer, after it has been completely removed by surgery. The goal is to see if nivolumab can help keep the cancer from coming back longer than if no additional treatment is given.

What is already known about the treatment

Nivolumab – Nivolumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials as an adjuvant therapy for patients with completely resected Stage IIb/c melanoma, a type of skin cancer. The main goal of using nivolumab in this context is to prevent the cancer from returning after surgery. At the molecular level, nivolumab works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immunotherapy drug, specifically a checkpoint inhibitor, which enhances the body's natural defenses to fight cancer.

Investigated diseases

Stage IIB/C Melanoma – Melanoma is a type of skin cancer that originates in the pigment-producing melanocytes. Stage IIB/C melanoma indicates a more advanced form where the tumor is thicker and may have ulceration, but it has not spread to distant sites. In this stage, the cancer is confined to the skin and possibly nearby lymph nodes. The progression involves the potential for the cancer to grow deeper into the skin and possibly spread to nearby lymph nodes. If not managed, it can advance to more severe stages where it may metastasize to other parts of the body. The focus in this stage is on monitoring for recurrence and managing any local spread.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502354-14-00Protocol codeCA209-76KEstimated enrolment1 059 patientsSponsorBristol-Myers Squibb Services Unlimited Company

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