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Study of 89Zirconium-labeled ipilimumab distribution in patients with metastatic melanoma receiving ipilimumab/nivolumab combination therapy

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 study focuses on patients with metastatic melanoma, an advanced form of skin cancer that has spread to other parts of the body. The study will investigate how a medication called ipilimumab (brand name YERVOY) moves through and distributes within the body when combined with another medication called nivolumab.

The research aims to understand how a specially labeled version of ipilimumab (marked with 89Zirconium) is taken up by tumor sites and other tissues in the body. The medication is given through intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The labeled medication allows researchers to track where the drug goes in the body and how it interacts with cancer cells.

During the study, participants will receive combination treatment with both ipilimumab and nivolumab. The study involves taking pictures of the body to see where the labeled medication collects. These images help researchers understand how the medication works in patients with metastatic melanoma. The maximum treatment period with the study medication is 3 months, with a maximum daily dose of 10 mg and a total maximum dose of 40 mg.

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 assessment

    A diagnostic scan (CT or MRI) will be performed to identify and measure tumor lesions

    Blood samples will be collected to assess baseline conditions

    Your physical condition will be evaluated using the WHO Performance Status scale

  2. Step 2

    Treatment preparation

    You will receive an injection of 89Zr-ipilimumab (a specially labeled version of ipilimumab that can be tracked in your body)

    This medication will be given through an intravenous infusion (directly into your vein)

  3. Step 3

    Combination therapy initiation

    You will begin treatment with a combination of two medications: ipilimumab and nivolumab

    Both medications will be administered through intravenous infusion

  4. Step 4

    Monitoring and assessment

    Your response to treatment will be evaluated at weeks 12 and 24

    After that, assessments will continue every 12 weeks

    Regular blood samples will be taken to monitor your body's response

    Any side effects will be recorded and assessed using standardized criteria

    Scans will be performed to track how the labeled medication spreads in your body

  5. Step 5

    Long-term follow-up

    Your overall health and survival will be monitored throughout the study period

    The study is expected to continue until December 2033

Who can join the trial?

8 criteria

  • You must have advanced melanoma (a type of skin cancer that has spread to other parts of the body)
  • You must be scheduled to receive combined treatment with nivolumab and ipilimumab (medications that help your immune system fight cancer)
  • You must be 18 years or older
  • You must have confirmation of cancer through tissue examination (histological) or cell examination (cytological)
  • You must have good physical ability to perform daily activities (WHO Performance Status of 0 or 1, meaning you can care for yourself and are either fully active or restricted only in physically strenuous activities)
  • You must have at least one measurable tumor that can be evaluated during the study
  • You must read, understand, and sign an informed consent form before any study procedures begin
  • You must be able to attend all study appointments and follow study requirements

Who cannot join the trial?

14 criteria

  • History of severe allergic reactions to any medications or substances
  • Pregnant or breastfeeding women
  • Active brain metastases (cancer that has spread to the brain) that are not treated
  • Serious heart conditions, including heart failure or recent heart attack
  • Active autoimmune diseases (conditions where the immune system attacks healthy cells)
  • Current or recent use of immunosuppressive medications (drugs that weaken the immune system)
  • Active infections, including hepatitis B, hepatitis C, or HIV
  • Other active cancers requiring treatment (except for certain skin cancers)
  • Inability to undergo PET/CT imaging (special type of body scan)
  • Previous treatment with ipilimumab or nivolumab (types of immunotherapy medications)
  • Major surgery within 4 weeks before starting the study
  • Participation in other clinical trials within 30 days before this study
  • Severe liver or kidney problems
  • Any condition that could interfere with the study procedures or patient safety
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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

  • Amsterdam UMC

    Responsive

    The NetherlandsAmsterdam, The Netherlands

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Investigated drugs

  • Ipilimumab

    is a medication used to treat advanced melanoma (a type of skin cancer). It works by helping your immune system fight cancer cells. It belongs to a group of drugs called immune checkpoint inhibitors, which help the body's immune cells recognize and attack cancer cells.

  • Nivolumab

    is another immunotherapy medication that works together with ipilimumab. It also helps the immune system fight cancer cells but works in a slightly different way. When used in combination with ipilimumab, it can provide enhanced treatment for melanoma.

  • 89Zirconium-labeled ipilimumab

    is a special version of ipilimumab that has been tagged with a radioactive tracer (89Zirconium). This allows doctors to see where the medication goes in the body using special imaging techniques. It is used for diagnostic purposes to understand how the treatment is working and where it is concentrating in the body.

What is already known about the treatment

  • Ipilimumab

    A monoclonal antibody medication administered through intravenous infusion, used primarily in the treatment of advanced melanoma and skin cancer. The drug works by targeting and blocking CTLA-4, a protein that normally helps keep immune system T-cells in check, thereby enhancing the body's immune response against cancer cells. As an immunotherapy agent, ipilimumab belongs to the class of immune checkpoint inhibitors and has shown significant effectiveness in clinical trials when used alone or in combination with other immunotherapy drugs like nivolumab, particularly in patients with metastatic melanoma.

  • Nivolumab

    An immunotherapy medication delivered through intravenous infusion that belongs to the class of PD-1 inhibitors, primarily used in treating advanced melanoma and other types of cancer. The drug works by blocking the PD-1 protein on T-cells, which helps these immune cells recognize and attack cancer cells more effectively. When combined with ipilimumab, nivolumab has demonstrated enhanced therapeutic effects in treating metastatic melanoma, though this combination may also increase the risk of immune-related side effects.

Investigated diseases

  • Skin Cancer

    A condition where skin cells begin to grow abnormally and uncontrollably, forming malignant tumors in the skin tissues. It typically develops on areas of skin exposed to sunlight, but can occur anywhere on the body. The disease can develop from various types of skin cells and may appear as new growths or changes in existing moles or skin patches.

  • Advanced Melanoma

    A serious form of skin cancer that begins in melanocytes, the cells that produce melanin (skin pigment). In its advanced stage, the cancer has spread beyond its original site to other parts of the body. The disease typically starts as changes in existing moles or appears as new, unusual-looking dark spots on the skin. Advanced melanoma means the cancer cells have invaded deeper into the skin or spread to other tissues or organs.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516547-11-00Estimated enrolment24 patientsSponsorAmsterdam UMC Stichting

sourced from the EU Clinical Trials Register and site verification

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