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Study on Stopping Nivolumab or Pembrolizumab in Advanced Melanoma Patients After Achieving a Response

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 effects of stopping treatment in patients with advanced or metastatic melanoma, a type of skin cancer. The study involves two medications: nivolumab (also known as OPDIVO) and pembrolizumab (also known as KEYTRUDA). These medications are given as a solution through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to observe what happens when patients who have shown a complete or partial response to these treatments stop taking them. The study will monitor the ongoing response of the cancer after stopping the medication. Patients will be observed over a period to see if the cancer remains under control without the continued use of the medication.

Participants in the study will have regular check-ups and imaging tests, such as MRI or CT scans, to monitor their condition. The study aims to understand the long-term effects of stopping treatment and whether the cancer remains stable or progresses. This information could help in making future treatment decisions for patients with advanced melanoma.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment

    Receive treatment with either nivolumab or pembrolizumab. These are medications given through an intravenous infusion, which means they are administered directly into a vein.

    The treatment is part of a first-line therapy for advanced or metastatic melanoma, a type of skin cancer that has spread to other parts of the body.

  2. Step 2

    Response evaluation

    Undergo regular evaluations to assess the response of the tumor to the treatment. This involves imaging tests such as a CT scan every 12 weeks, with a margin of one week, to monitor changes in the tumor size.

    The evaluations follow a standard set of criteria known as RECIST v1.1, which helps in determining whether the tumor is shrinking, stable, or growing.

  3. Step 3

    Discontinuation of treatment

    If a complete response (CR) or partial response (PR) is achieved, the treatment with nivolumab or pembrolizumab may be discontinued within six weeks, with a margin of one week, after confirmation of the response.

    A complete response means no detectable cancer remains, while a partial response indicates a significant reduction in the size of the tumor.

  4. Step 4

    Monitoring after discontinuation

    Continue to be monitored for ongoing response to the treatment after discontinuation. This includes regular follow-up visits and imaging tests to ensure the cancer remains under control.

    The primary goal is to observe the rate of ongoing responses at 24 months after the initial start of treatment.

  5. Step 5

    Potential reintroduction of treatment

    If the cancer progresses after discontinuation, there may be a reintroduction of the same treatment with nivolumab or pembrolizumab, or the introduction of other systemic therapies.

    The decision to restart treatment will depend on the specific circumstances and the response of the cancer to previous treatments.

  6. Step 6

    Assessment of quality of life

    Throughout the trial, assessments will be made regarding changes in quality of life, including any changes in daily activities, work productivity, and emotional well-being.

    These assessments help in understanding the broader impact of the treatment and its discontinuation on overall health and lifestyle.

Who can join the trial?

7 criteria

  • Must be **18 years or older**.
  • Must have **advanced or metastatic melanoma**. This means the melanoma has spread to other parts of the body.
  • Currently receiving **first-line treatment** with either **nivolumab** or **pembrolizumab** for advanced or metastatic melanoma. Previous treatments, including **immunotherapy** (a type of treatment that helps your immune system fight cancer) for melanoma that could be surgically removed, are allowed.
  • Must have a **documented target lesion**. This means there is a specific area of cancer that can be measured on a **CT scan** (a type of detailed imaging test) when starting treatment with nivolumab or pembrolizumab.
  • Must have a **tumor response evaluation** every 12 weeks, give or take a week, using a CT scan. This is to check how the cancer is responding to treatment.
  • Must have an **MRI of the brain** to check for any cancer spread to the brain before stopping treatment with nivolumab or pembrolizumab.
  • Must be willing to **stop taking nivolumab or pembrolizumab** within 6 weeks, give or take a week, after confirming a **complete response (CR)** or **partial response (PR)**. This means the cancer has either disappeared or shrunk significantly.

Who cannot join the trial?

4 criteria

  • Patients who have not been diagnosed with advanced or metastatic melanoma. This means the melanoma has spread to other parts of the body.
  • Patients who have not achieved a CR (Complete Response) or PR (Partial Response) with first-line monotherapy using nivolumab or pembrolizumab. A Complete Response means the cancer is no longer detectable, and a Partial Response means the cancer has shrunk but is still present.
  • Patients who are not within the specified age range for the study. The study includes certain age groups, and patients must fall within these groups to participate.
  • Patients who belong to a vulnerable population. This means groups of people who might be at a higher risk of harm or exploitation.
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Investigated drugs

  • Nivolumab

    is a medication used in this trial to treat advanced melanoma. It works by blocking a protein called PD-1 on the surface of immune cells, which helps the immune system attack cancer cells more effectively. Patients in the trial receive this medication as a first-line treatment until they achieve a complete or partial response.

  • Pembrolizumab

    is another medication used in the trial for treating advanced melanoma. Similar to nivolumab, it targets the PD-1 protein on immune cells, enhancing the body's immune response against cancer cells. This medication is also given as a first-line treatment, and patients may stop using it once they achieve a complete or partial response.

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 advanced melanoma, where it helps to manage the disease by enhancing the body's immune response against cancer cells. At the molecular level, nivolumab works by blocking the PD-1 protein on immune cells, preventing cancer cells from evading the immune system. It is classified as an immune checkpoint inhibitor.

  • Pembrolizumab

    Pembrolizumab is also administered through intravenous infusion, usually in a hospital or clinic. It is an established treatment for several types of cancer, with extensive documentation in medical literature. The primary therapeutic use of pembrolizumab is for advanced melanoma, where it aids in controlling the disease by boosting the immune system's ability to fight cancer. Its mechanism of action involves inhibiting the PD-1 protein on immune cells, thereby allowing the immune system to better detect and attack cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor.

Investigated diseases

Melanoma – Melanoma is a type of skin cancer that begins in the melanocytes, which are the cells responsible for producing the pigment melanin. It often appears as a new mole or a change in an existing mole, typically with irregular borders and multiple colors. As it progresses, melanoma can grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. The disease is more common in areas of the skin that have been exposed to the sun, but it can also occur in areas not typically exposed. Early stages may be limited to the skin, but advanced stages involve metastasis, where cancer cells travel through the bloodstream or lymphatic system. Regular skin checks and awareness of changes in moles are important for early detection.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516937-10-01Protocol codeSafe StopEstimated enrolment200 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

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