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

2 1 1 1

What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Avmmmqxrg Uoi	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.11.2015

Trial locations

Investigated drugs:

Ipilimumab

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.

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 ID:

2024-516547-11-00

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?