AuthorisedTherapeutic exploratory (Phase II)Interventional

Multicentric trial evaluating the correlation between early PSMA-PET change and response to systemic treatment for first-line metastatic clear cell Renal Carcinoma Cell.

This study is for people with kidney cancer that has spread to other parts of the body. We're investigating if an early change seen on a special type of scan, called a PSMA-PET scan, can tell us whether a cancer treatment is likely to be effective. Participants will have this scan before starting treatment and again after six weeks. We'll then compare these scan results with how well the cancer is controlled after six months with treatments that combine two types of drugs (immunotherapy plus another drug, or two immunotherapies). The aim is to find a quicker way to understand if a treatment is working, helping doctors make the best decisions for patients.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Cliniques Universitaires Saint-Luc

Enrolment target

Start

21 Mar 2025

metastatic clear cell Renal Carcinoma Cell

What is this study about?

This study is looking into a new way to understand how well treatments are working for a type of kidney cancer called 'clear cell renal carcinoma' that has spread in the body. We're using a special scan called a PSMA-PET scan. This scan can show us specific markers on cancer cells. We want to see if changes in these markers on the scan, very early on after starting treatment, can predict if the treatment will be successful in controlling the cancer later.

Participants will have a PSMA-PET scan before they start their new cancer treatment and then another one about six weeks after starting. The treatments being looked at are combinations of different cancer drugs, specifically immunotherapy (ICI) drugs, sometimes with another type of drug called a TKI. We will then compare these early scan changes to how well their cancer is controlled after six months of treatment.

The main goal is to find out if these early scan changes can give doctors a better idea of whether the cancer treatment is effective. If successful, this could help doctors make faster and more informed decisions about treatment plans, potentially improving care for people with advanced kidney cancer.

Key takeaways

This study is for adults with advanced clear cell kidney cancer, starting their first treatment.
It uses special PSMA-PET scans to see how cancer changes after treatment starts.
The goal is to see if early scan changes can predict how well treatment works long-term.
This could help doctors choose the best treatments more quickly.
Participation involves extra scans and close monitoring alongside your regular care.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

You must also have clear cell kidney cancer that has spread to other parts of your body. This study specifically focuses on people who are just starting their very first treatment for this advanced kidney cancer.

Your medical team will check other specific health details to make sure this study is safe and right for you, but generally, these are the main points for who can consider joining.

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.

Are you 18 years old or older?
Do you have clear cell kidney cancer that has spread?
Are you about to start your very first treatment for this advanced kidney cancer?
Are you able to have PSMA-PET scans?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll have specific appointments and tests. You will have a special scan called a PSMA-PET scan before you start your cancer treatment. Then, about six weeks after beginning your new medication, you'll have another PSMA-PET scan. Your ongoing cancer treatment will be as planned by your medical team, which will likely be a combination of two types of drugs. We will then follow how your cancer responds to treatment over six months using your regular medical assessments. The exact number of visits will depend on your treatment schedule and how often your doctor usually assesses your condition.

Potential risks and benefits

Participating in research studies like this can sometimes offer benefits, such as closer monitoring of your condition. However, there are also potential risks, including side effects from the study procedures like the scans, although these are generally minor. The treatments themselves have their own known risks and side effects that your doctor will discuss with you. You should know that taking part is entirely your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is a PSMA-PET scan?

It's a special type of scan that helps doctors see certain features on cancer cells, which can help track the cancer.

What kind of cancer is this study for?

This study is for a specific type of advanced kidney cancer called clear cell renal carcinoma that has spread in the body.

What kind of treatments are involved?

The study looks at common first-line treatments for this cancer, which are usually combinations of immunotherapy drugs.

Why is this study important?

It aims to find out if early scan changes can predict whether a cancer treatment is working, which could help guide doctors' decisions faster.

Will taking part change my cancer treatment?

No, this study observes how you respond to standard treatments. It doesn't change the treatment plan your doctor usually recommends for you.