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Study to Evaluate IOpener-Melanoma Test for Predicting Response to Immunotherapy in Stage III or IV Skin 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 studying cutaneous melanoma, a type of skin cancer, specifically for patients with unresectable stage III or stage IV disease. The study aims to evaluate the clinical performance of the IOpener-melanoma test in predicting how patients will respond to immune checkpoint inhibitors (ICIs), which are medications that help the immune system recognize and attack cancer cells. The test results will be used to guide treatment selection for patients.

The study focuses on patients whose melanoma cannot be surgically removed or has spread to other parts of the body. Patients with brain metastases (cancer that has spread to the brain) may participate if these metastases are asymptomatic or have been treated. The purpose is to determine if the IOpener-melanoma test can accurately predict which patients will benefit from combination therapy or monotherapy with immune checkpoint inhibitors.

During the study, participants will receive treatment based on their IOpener-melanoma test results. The study will track how patients respond to treatment, including how long they live without their disease getting worse, overall survival, and quality of life measures.

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

    Enrollment and Initial Assessment

    After joining the study, you will undergo an initial assessment to confirm your eligibility. You have been diagnosed with unresectable stage III or stage IV cutaneous melanoma (a type of skin cancer that cannot be completely removed by surgery or has spread).

    During this assessment, your medical history will be reviewed and your current condition will be evaluated to ensure you meet all study criteria, including having a life expectancy of more than 3 months.

  2. Step 2

    IOpener-Melanoma Testing

    You will undergo the IOpener-melanoma test, which is designed to predict how well you might respond to immunotherapy treatment.

    The results of this test will help your doctor determine whether you should receive combination immunotherapy or single-agent (mono) immunotherapy.

  3. Step 3

    Treatment Assignment

    Based on your IOpener-melanoma test results, you will receive one of the following immunotherapy regimens:

    Mono immunotherapy: Either pembrolizumab (Keytruda) or nivolumab (Opdivo) alone, OR

    Combination immunotherapy: Nivolumab plus ipilimumab, or another combination that may include PHF00230MIG.

  4. Step 4

    Treatment Period

    You will receive the assigned immunotherapy treatment according to standard dosing schedules. The exact frequency and duration will follow standard medical guidelines for melanoma treatment.

    Throughout the treatment period, you will have regular visits to assess how your body is responding to the treatment and to monitor for any side effects.

  5. Step 5

    Monitoring and Evaluation

    Your tumor response will be regularly evaluated using RECIST 1.1 criteria (a standardized way to measure if tumors are shrinking, growing, or staying the same).

    These evaluations will determine your Best Overall Response, Disease Control Rate (DCR), and Overall Response Rate (ORR).

    You will also complete Quality of Life questionnaires (EQ-5D-5L) at scheduled visits to assess how the treatment is affecting your daily life.

  6. Step 6

    Follow-up Period

    After completing the treatment phase, you will enter a follow-up period where your health status will continue to be monitored.

    The study will track your Progression Free Survival (PFS) (how long you live without the cancer growing) and Overall Survival (OS) (how long you live overall).

    A key measurement will be your 1-Year PFS (whether you live for at least one year without the cancer progressing).

  7. Step 7

    Study Completion

    The study is expected to run until July 1, 2025, though individual participation length will vary depending on when you join and how you respond to treatment.

    Throughout the study, your medical costs related to the trial procedures will be recorded for research purposes.

Who can join the trial?

7 criteria

  • You must have cutaneous melanoma (skin cancer that develops from pigment-producing cells) that is either:
    • Unresectable stage III (cancer that cannot be completely removed by surgery and has spread to nearby lymph nodes), or
    • Stage IV (cancer that has spread to distant parts of the body)
    • Your doctor must be considering treatment with immune checkpoint inhibitors (medications that help your immune system recognize and attack cancer cells)
    • If you have brain metastases (cancer that has spread to the brain), they must be asymptomatic (not causing symptoms) or have already been treated
    • You must have a life expectancy of more than 3 months
    • You must be 18 years or older
    • You must provide written informed consent (agreement to participate in the study after being informed about it)

Who cannot join the trial?

8 criteria

  • You cannot participate if you have been diagnosed with uveal melanoma (a type of eye cancer) or mucosal melanoma (cancer that starts in the mucous membranes).
  • If you have already received prior treatment for your advanced melanoma, you cannot join this study.
  • You cannot participate if you are unable to provide sufficient tumor tissue for testing.
  • If you have any serious medical condition that would make it unsafe for you to participate, you will not be eligible.
  • Women who are pregnant or breastfeeding cannot join this study.
  • If you have a history of another cancer that might affect the interpretation of the study results, you may not be eligible.
  • You cannot participate if you are already enrolled in another interventional clinical trial.
  • If you have a known hypersensitivity (severe allergic reaction) to any of the study treatments, you cannot join.
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Investigated drugs

  • Combination or Mono Immunotherapy

    These are treatments that use the body's immune system to fight melanoma (skin cancer). Combination therapy uses more than one immunotherapy drug together, while mono therapy uses a single immunotherapy drug. These treatments help your immune system recognize and attack cancer cells.

  • IOpener-melanoma test

    This is a diagnostic test that predicts how well a patient with advanced melanoma might respond to immunotherapy treatments. The test results help doctors decide whether to use combination immunotherapy or a single immunotherapy drug for treatment.

What is already known about the treatment

IOpener-melanoma - A diagnostic test designed to predict patient response to immunotherapy treatments (either combination or mono therapy) in individuals with stage III or IV cutaneous melanoma. This test helps clinicians make more informed decisions about treatment selection by identifying which patients are likely to benefit from specific immunotherapy approaches. IOpener-melanoma works by analyzing certain biomarkers or genetic patterns in patient samples that correlate with treatment outcomes, though the exact molecular mechanisms it measures aren't specified in the available information. The test is currently being evaluated in a prospective, multicenter clinical performance study called CO2MO to validate its effectiveness in guiding standard-of-care treatment decisions for advanced melanoma patients.

Investigated diseases

Melanoma – A type of skin cancer that develops from the pigment-producing cells known as melanocytes. Melanoma begins when healthy melanocytes change and grow out of control, forming a cancerous tumor. It typically starts as a new, unusual-looking growth or a change in an existing mole. If not caught early, melanoma can grow deeper into the skin and spread to other parts of the body through the lymphatic system or bloodstream. The progression of melanoma is often described in stages, from early localized disease to advanced metastatic disease. Risk factors include excessive exposure to ultraviolet radiation, family history, and certain genetic mutations.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520913-29-00Protocol codeCO2MOEstimated enrolment96 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

sourced from the EU Clinical Trials Register and site verification

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