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Study on Early Discontinuation of Nivolumab and Ipilimumab in Patients with Advanced Melanoma

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 the treatment of melanoma, a type of skin cancer that can spread to other parts of the body. The study involves the use of two medications: ipilimumab and nivolumab. These medications are given together as a first-line treatment, which means they are the first treatments used for patients with advanced melanoma that cannot be removed by surgery or has spread to other parts of the body. The purpose of the study is to understand the effects of stopping nivolumab early in patients who have shown a complete or partial response to the treatment.

Participants in the study will receive the medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will monitor patients over time to see how their cancer responds to the treatment and whether the response continues after stopping nivolumab. The study will also look at the overall survival of patients and their quality of life during and after the treatment. Patients will be asked to fill out questionnaires about their quality of life at various points during the study.

The study will last for several years, with regular check-ups to assess the ongoing response to the treatment. The researchers aim to determine if stopping nivolumab early can still provide long-term benefits for patients with advanced melanoma. This information could help improve treatment plans for future patients with this type of cancer.

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

    Initial treatment phase

    The treatment begins with the administration of two medications: ipilimumab and nivolumab. These are given through a vein, a method known as intravenous administration.

    The goal of this phase is to achieve a complete or partial response in the treatment of melanoma, which is a type of skin cancer.

  2. Step 2

    Response evaluation

    After starting the treatment, the response is evaluated using a diagnostic CT scan. This scan helps to document any changes in the size of the cancer.

    If a complete or partial response is confirmed, a low-dose CT scan may be used for further evaluation.

  3. Step 3

    Discontinuation of nivolumab

    If a complete or partial response is achieved, the use of nivolumab is discontinued early. This should occur no later than 9 months after the start of the treatment.

    The decision to stop nivolumab is based on the response evaluation and must be confirmed within a specific timeframe.

  4. Step 4

    Follow-up and monitoring

    Regular follow-up visits are scheduled to monitor the ongoing response to the treatment. These visits include imaging tests to check for any changes in the cancer.

    The follow-up schedule includes evaluations every 12 weeks in the first year, every 4 months in the second year, and every 6 months in the third year.

  5. Step 5

    Quality of life assessment

    Throughout the trial, quality of life is assessed using questionnaires. These are completed at the start of the trial, every 12 weeks in the first year, every 4 months in the second year, every 6 months in the third year, and once in the fifth year.

    The aim is to understand the impact of the treatment on daily life and overall well-being.

Who can join the trial?

8 criteria

  • Must be 18 years of age or older.
  • Must have unremovable stage III or metastatic melanoma. This means the melanoma cannot be surgically removed and has spread to other parts of the body.
  • Must have received at least one dose of a treatment called ipilimumab-nivolumab and be considered for ongoing treatment with nivolumab. Previous treatments for melanoma that could be surgically removed are allowed.
  • Must have a response evaluation using a special type of scan called a diagnostic CT to check the size of the cancer. This scan should be done every 12 weeks from the start of treatment.
  • Must be included in the study after showing a complete response (CR) or partial response (PR) to treatment, as confirmed by the response evaluation. This means the cancer has either disappeared or reduced in size.
  • Must have a brain MRI to check for cancer spread to the brain before stopping the ipilimumab-nivolumab treatment.
  • If there are previously treated brain metastases, the patient can participate if the brain metastases are not causing symptoms and a brain MRI is done at the start and during treatment.
  • Must have signed and dated an informed consent form, which means agreeing to participate in the study after understanding all the details.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer other than melanoma cannot participate. Melanoma is a type of skin cancer.
  • Patients who have had surgery to remove their melanoma cannot participate. This is referred to as "irresectable" melanoma, meaning it cannot be surgically removed.
  • Patients who are not in stage III or have not reached the metastatic stage of melanoma cannot participate. Stage III means the cancer has spread to nearby lymph nodes, and metastatic means it has spread to other parts of the body.
  • Patients who have not been treated with the specific combination of drugs called ipilimumab and nivolumab cannot participate. These are medications used to treat melanoma.
  • Patients who have not achieved a complete response (CR) or partial response (PR) to treatment cannot participate. A complete response means no signs of cancer, and a partial response means the cancer has shrunk but is still present.
  • Patients who are not within the specified age range for the trial cannot participate. The age range is typically defined by the trial organizers.
  • Patients who belong to a vulnerable population, such as those unable to give informed consent, cannot participate.
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Investigated drugs

  • Ipilimumab

    is a medication used in this trial to treat patients with advanced melanoma. It works by helping the immune system attack and destroy cancer cells. Ipilimumab is often used in combination with other medications to enhance its effectiveness in fighting cancer.

  • Nivolumab

    is another medication used in this trial for patients with advanced melanoma. It also helps the immune system target and kill cancer cells. In this study, patients may stop taking nivolumab early if they achieve a significant reduction in their cancer, as determined by specific medical criteria.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently approved and widely used in the treatment of various cancers, including melanoma, and is well-documented in medical literature. The main therapeutic indication for nivolumab is the treatment of unresectable or metastatic melanoma. 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 an immune checkpoint inhibitor.

  • Ipilimumab

    Ipilimumab is also administered via intravenous infusion, usually in a hospital or clinic. It is an established medication in oncology, particularly for treating melanoma, and is supported by extensive research and clinical data. The primary use of ipilimumab is for patients with advanced melanoma. Its mechanism of action involves blocking the CTLA-4 protein on T-cells, which boosts the immune system's ability to attack cancer cells. Ipilimumab is categorized as an immune checkpoint inhibitor.

Investigated diseases

Melanoma – Melanoma is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. It is characterized by the uncontrolled growth of these cells, often appearing as a new or changing mole on the skin. Melanoma can occur anywhere on the body, but it is most commonly found on areas exposed to the sun, such as the back, legs, arms, and face. As it progresses, melanoma can spread to other parts of the body, including the lymph nodes and internal organs. Early stages may be limited to the skin, but advanced stages involve deeper tissue invasion and potential metastasis. Regular skin checks and awareness of changes in moles are important for early detection.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516938-34-00Protocol codeSafe Stop IPI-NIVOEstimated enrolment80 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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