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Study of Nivolumab for Patients with High-Risk Stage II 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 stage II high-risk melanoma, a type of skin cancer that has been surgically removed but still poses a risk of returning. The treatment being tested is called nivolumab, also known by its code names BMS936558 and ABP 206. Nivolumab is given as a solution through an infusion into the vein. The purpose of the study is to see how effective nivolumab is in preventing the return of melanoma in patients who are at high risk, as determined by a special test called the MelaGenix assay.

Participants in the study will be randomly assigned to one of two groups. One group will receive nivolumab, while the other group will be observed without receiving the medication. The study will follow participants over time to see if the melanoma returns or if there are any other health changes. The main focus is on how long participants remain free from melanoma returning, which is referred to as Relapse-Free Survival (RFS). The study will also look at other outcomes, such as how long participants live without the cancer spreading to other parts of the body, known as distant metastasis-free survival, and overall survival rates.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the status of their melanoma. The study aims to provide valuable information on whether nivolumab can help prevent the return of melanoma in patients who are at high risk, potentially offering a new treatment option for this group. The study is expected to continue until 2027.

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, a diagnosis of stage II melanoma from a primary skin site after surgery is confirmed.

    Eligibility is determined through laboratory tests and a risk analysis using the MelaGenix assay.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of three groups: Arm A, Arm B, or Arm C.

    Arm A receives the medication nivolumab, while Arm B and Arm C are observed without medication.

  3. Step 3

    Treatment with nivolumab

    Participants in Arm A receive nivolumab as a solution for infusion.

    The medication is administered intravenously, which means it is given through a vein.

  4. Step 4

    Observation period

    Participants in Arm B and Arm C are monitored without receiving the medication.

    The focus is on tracking the time until any tumor recurrence or other significant events.

  5. Step 5

    Follow-up and monitoring

    All participants are regularly monitored for relapse-free survival, which is the time from joining the study until any tumor recurrence or death.

    Additional outcomes such as distant metastasis-free survival and overall survival are also evaluated.

Who can join the trial?

20 criteria

  • Must have a confirmed diagnosis of **stage II melanoma** that started on the skin and has been treated with surgery.
  • Blood tests must show certain levels:
    • **White blood cells**: At least 2000 per microliter.
    • **Neutrophils**: At least 1500 per microliter.
    • **Platelets**: At least 100,000 per microliter.
    • **Hemoglobin**: At least 9.0 grams per deciliter.
    • **Serum creatinine**: No more than 1.5 times the normal limit.
    • **Creatinine clearance**: At least 40 milliliters per minute.
    • **AST/ALT**: No more than 3 times the normal limit.
    • **Total Bilirubin**: No more than 1.5 times the normal limit, except for those with Gilbert Syndrome, who can have up to 3.0 mg/dL.
    • Women who can have children must have a negative pregnancy test within 72 hours before joining the study.
    • Women who can have children and men with partners who can have children must agree to use a highly effective form of birth control during the study and for at least 5 months after the last dose of the study medication (only for those in Arm A).
    • Must have had a **sentinel node biopsy** that did not find melanoma deposits. A sentinel node biopsy is a procedure to check if cancer has spread to the lymph nodes.
    • Must register for the study no later than 12 weeks after the sentinel node biopsy.
    • Must provide tumor tissue from the primary tumor for special tests called **biomarker analyses**.
    • Must be classified by a test called **MelaGenix risk analysis**.
    • Must be between 18 and 80 years old.
    • Must sign a written consent form agreeing to participate in the study.
    • Must be willing and able to attend scheduled visits, follow the treatment plan, and complete required tests and other study requirements.
    • Must have a life expectancy of at least five years, not counting the melanoma diagnosis.
    • Must have an **ECOG performance status** of 0-1, which means being fully active or having some symptoms but being able to carry out light work.

Who cannot join the trial?

10 criteria

  • Patients who have not had surgery for their **Stage II melanoma**. **Melanoma** is a type of skin cancer, and **Stage II** means it is in an early stage but has grown deeper into the skin.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of other cancers, unless they have been cancer-free for a certain period.
  • Patients who have an active infection that requires treatment.
  • Patients who have a known allergy to the study medication or its ingredients.
  • Patients who have received certain treatments for melanoma in the past that might affect the study results.
  • Patients who have a condition that affects their immune system, which is the body's defense against illness.
  • Patients who have a mental health condition that might make it difficult to follow the study procedures.
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Investigated drugs

Nivolumab is a medication used in this clinical trial to treat patients with stage II high-risk melanoma. It is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. In this trial, nivolumab is being tested to see if it can improve the time patients remain free from cancer recurrence compared to those who are only observed without receiving the medication.

What is already known about the treatment

Nivolumab – Nivolumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently well-established in medical literature as an immunotherapy drug used for various cancers, including melanoma. The main therapeutic indication for nivolumab in this trial is for patients with stage II high-risk melanoma following surgery. 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 a monoclonal antibody and is part of the immune checkpoint inhibitor class of drugs.

Investigated diseases

Stage II Melanoma – This is a type of skin cancer that originates from melanocytes, the cells responsible for producing pigment in the skin. In Stage II, the melanoma is more advanced than Stage I but has not yet spread to lymph nodes or distant sites. It is characterized by a thicker tumor that may have ulceration, which is a breakdown of the skin over the tumor. The progression involves the potential for the tumor to grow deeper into the skin and possibly spread to nearby tissues. After surgical removal, there is a risk of recurrence, which means the cancer can return at the original site or elsewhere in the body. Monitoring for signs of recurrence is crucial in managing the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509394-23-00Protocol codeCA209-7DLEstimated enrolment423 patientsSponsorUniversitaetsklinikum Essen AöR

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