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Study on Early Detection of Side Effects in Metastatic Melanoma Patients Using Zirconium (89Zr) Crefmirlimab Berdoxam Imaging

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with metastatic melanoma, a type of skin cancer that has spread to other parts of the body. The study is investigating a new treatment called [89Zr]Zr-Df-IAB22M2C, which is used in combination with a type of cancer treatment known as immune checkpoint inhibitor therapy. This therapy helps the immune system recognize and attack cancer cells more effectively.

The purpose of the study is to explore the possibility of detecting side effects early in patients receiving this treatment. This is done by using a special imaging technique called PET imaging to look at the presence of certain immune cells, known as CD8+ lymphocytes, in the body. These cells are a type of white blood cell that plays a crucial role in the immune response against cancer.

During the study, participants will receive the [89Zr]Zr-Df-IAB22M2C injection, and PET imaging will be used to monitor changes in the immune cells before and after the first cycle of immune checkpoint inhibitor therapy. The study aims to determine if this method can help identify patients who might experience significant side effects from the treatment, allowing for better management of their care.

The research process

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

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and ability to adhere to the study schedule.
Informed consent is required before any study-related procedures begin.
Step 2
Initial assessment
An initial assessment is conducted to gather baseline data. This may include medical history review and physical examination.
Step 3
Administration of the study medication
The study involves the administration of [89Zr]Zr-Df-IAB22M2C via injection. This is a specialized imaging agent used to detect immune cell activity.
The injection is part of a noninvasive imaging process to assess immune cell infiltration.
Step 4
Imaging procedures
After the injection, imaging is performed using PET (Positron Emission Tomography) to visualize the distribution of the agent in the body.
This imaging helps in detecting immune-related side effects and assessing the response to immune checkpoint inhibitor therapy.
Step 5
Monitoring and follow-up
Regular monitoring is conducted to observe any side effects and to evaluate the effectiveness of the treatment.
Follow-up visits are scheduled to repeat imaging and assess changes over time.
Step 6
Completion of the study
The study concludes with a final assessment to gather data on the overall impact of the treatment and imaging results.
Participants are informed about the findings related to their health and any further recommendations.

Who can join the trial?

7 criteria

Male or female patients who are **18 years or older** at the time of signing the informed consent.
Patients with **metastasized** (cancer that has spread to other parts of the body) or **irresectable melanoma** (melanoma that cannot be removed by surgery).
Patients with an **ECOG Status of 2 or less**. This is a scale used to assess how a patient's disease is affecting their daily living abilities, with 0 being fully active and 5 being deceased.
Patients who are scheduled for **ICT** (immune checkpoint therapy) as recommended by a team of cancer specialists.
Patients must understand and voluntarily sign an **informed consent document** before any study-related assessments or procedures.
Patients must be able to follow the study visit schedule and meet other study requirements.
Patients must agree to use **double-barrier contraception** until the end of the study (28 days after the last injection of the study drug). This means using two forms of birth control to prevent pregnancy. This is required for females who can become pregnant and males with female partners who can become pregnant.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with melanoma cannot participate. Melanoma is a type of skin cancer.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are not part of the specified clinical trial group cannot participate. This group includes individuals with certain characteristics needed for the study.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.

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Verified sites

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Universitaetsklinikum Tuebingen AöR
Tuebingen, Germany

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Investigated drugs

[89Zr]Zr-Df-IAB22M2C is a special imaging agent used in this clinical trial. It helps doctors see how immune cells, specifically CD8+ lymphocytes, are behaving in the body. This imaging agent is used in PET scans to detect early side effects in patients with metastatic melanoma who are receiving immune checkpoint inhibitor therapy. By using this agent, doctors can noninvasively assess the immune response and potentially catch any side effects early on.

Zirconium (89Zr) Crefmirlimab Berdoxam

What is already known about the treatment

[89Zr]Zr-Df-IAB22M2C – This medication is administered through a PET imaging procedure, where it is used as a tracer to visualize immune cell activity in the body. It is currently being studied in clinical trials for its potential to detect side effects in patients with metastatic melanoma undergoing immune checkpoint inhibitor therapy. The main therapeutic indication is to assess CD8+ lymphocyte infiltration, which can help in identifying immune-mediated side effects early. At the molecular level, it binds to CD8+ T-cells, allowing for their visualization through PET scans. It falls under the pharmacological classification of radiopharmaceuticals used in diagnostic imaging.

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. Melanoma can develop on any skin surface, but it is more common in areas exposed to the sun, such as the back, legs, arms, and face. As it progresses, melanoma can grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. Early detection is crucial, as melanoma can be more effectively managed when identified at an early stage. Regular skin checks and monitoring of moles for changes are important for early detection.