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RecruitingPHASE2INTERVENTIONAL

CD8 PET Imaging in Metastatic Solid Tumours

This study is for people in the UK with advanced cancer that has spread or is hard to treat. It uses a special scanning technique, called a PET scan, before and during a type of cancer treatment known as PD-1 antibody therapy. This scan uses a small, safe amount of a substance called 89Zr-Df-crefmirlimab to help doctors see the cancer more clearly. The main aims are to understand if this new scanning method helps doctors see how well the treatment is working and if it is safe. This information could lead to better ways of treating advanced cancers in the future. The study involves taking pictures of the cancer and giving standard cancer medicines, and it will be carefully monitored by doctors.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
University Medical Center Groningen
Enrolment target
30
Start
11 Mar 2025
Estimated completion
01 Nov 2028

What is this study about?

This research study is about finding better ways to understand and treat advanced cancers that have spread in the body. It focuses on a special type of scan called a PET scan, which uses a particular substance (89Zr-Df-crefmirlimab) to create detailed pictures inside your body. The idea is to see if this scan can help doctors tell how well a new type of cancer treatment, called PD-1 antibody therapy, is working for you.

PD-1 antibody therapy (like Nivolumab or Cetrelimab) works by helping your own body's defence system, called the immune system, fight against cancer. This study is trying to find out if the special PET scan can give doctors a clearer picture of how these immune-boosting medicines are affecting the cancer. This could help them decide on the best treatment plan for each person.

By taking part, you would be helping doctors learn more about advanced cancer and how to treat it. The information gathered from this study could lead to new ways of assessing cancer treatment in the future, potentially benefiting many other patients.

Key takeaways

  • This study uses a special scan for advanced cancer.
  • It aims to see how well immune-boosting cancer treatments are working.
  • Participation involves special scans and standard cancer medicines.
  • It could help doctors find better ways to treat advanced cancers in the future.
  • Extra medical checks and monitoring are provided during the study.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with an advanced solid cancer that has either spread or is hard to treat. Your doctor must believe that treatment with a PD-1 antibody therapy (a type of immunotherapy) could be helpful for you.

Important points are that your cancer must have progressed after initial treatments, or there aren't any better standard treatments available. Doctors will also need to be able to take a small sample (biopsy) from at least one of your cancer areas, and your cancer needs to be measurable on scans. You should generally feel well enough to carry out most daily activities, with a good chance of living for at least 12 more weeks.

Finally, your blood tests need to show that your important organs, like your kidneys and liver, and your bone marrow (which makes blood cells), are working well enough for you to safely take part in the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have advanced solid cancer that has progressed after other treatments or for which no better standard treatment exists?
  3. Does your doctor think you might benefit from a PD-1 antibody cancer treatment?
  4. Are you generally able to carry out most daily activities?
  5. Are your blood tests (like kidney, liver, blood counts) within acceptable limits for the study?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would have a special type of scan called an 89Zr-Df-crefmirlimab PET scan. This type of scan uses a small amount of a special substance to show doctors how your cancer is behaving. This scan would be done before you start your PD-1 antibody therapy (Nivolumab or Cetrelimab) and then again during treatment.

Your doctors would regularly check your health and how you're responding to treatment using standard tests and scans. They would also take blood and urine samples to make sure you are well and that the treatment is safe for you. The total duration of your participation would depend on how your treatment progresses, and the exact schedule of visits would be explained in detail by the study team.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as receiving close medical attention and contributing to new knowledge that could help future patients. However, there's no guarantee that the study treatment will directly help your cancer. As with any medical procedure, there are potential risks, including side effects from the study drugs (Nivolumab, Cetrelimab), and exposure to a small amount of radiation from the PET scans. These will be fully explained to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • VUMC
    Verified postcode
    Amsterdam, Netherlands· Recruiting
  • University Medical Center Groningen
    Verified postcode
    Groningen, Netherlands· Recruiting
  • Vall d'Hebron Institute of Oncology (VHIO) / Vall d'Hebron Institute Research (VHIR)
    Verified postcode
    Barcelona, Spain· Not yet recruiting
  • University of Cambridge
    Verified postcode
    Cambridge, United Kingdom· Not yet recruiting

Common questions

What is 'PD-1 antibody therapy'?

It's a type of cancer treatment that helps your body's own immune system fight the cancer cells more effectively.

What is an '89Zr-Df-crefmirlimab PET scan'?

It's a special type of imaging scan that uses a small amount of a safe, traceable substance to take detailed pictures inside your body, helping doctors see the cancer.

Will I receive new medicine in this study?

The study focuses on a special scan. You will receive standard cancer medicines (Nivolumab or Cetrelimab) as part of your treatment plan, with the addition of the special scans.

Does taking part mean I get special treatment?

You will receive very close monitoring and care as a study participant, but the primary cancer treatments (Nivolumab or Cetrelimab) are standard therapies. The trial adds a special scan to learn more.

Can I leave the study at any time?

Yes, you are completely free to withdraw from the study at any point, and it will not affect your ongoing medical care.

How to find out more

Elisabeth GE de Vries, MD, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "CD8 PET Imaging in Metastatic Solid Tumours…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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