RecruitingPHASE2INTERVENTIONAL

Radiopharmaceutical Treatment of Advanced Kidney Cancer

This study is for adults with advanced kidney cancer that has spread and hasn't responded well to standard treatments like immunotherapy. We're testing a new treatment called 177Lu-PSMA-617. This treatment has already shown promise in treating advanced prostate cancer. It works by targeting a specific protein (PSMA) found on some kidney cancer cells and delivering a small amount of radiation directly to them, aiming to kill cancer cells while protecting healthy ones. Before joining, people will have a special scan to check if their cancer cells have this PSMA protein. The main goals are to see if this treatment is effective against kidney cancer and to check for any side effects. Participants will receive the treatment and have follow-up visits to monitor their health and how the treatment is working.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrolment target

Start

07 Apr 2026

Estimated completion

01 Jan 2029

Metastatic Clear Cell Renal Cell Carcinoma

What is this study about?

This study is looking into a new treatment for people in the UK who have advanced kidney cancer that has spread to other parts of their body. These are often people whose cancer has already been treated with other medicines like immunotherapy and targeted therapy, but the cancer has continued to grow. At this stage, there aren't many other treatment options available, so doctors are always looking for new ways to help.

The new treatment being tested is called 177Lu-PSMA-617. It's a special type of medicine known as a 'radiopharmaceutical.' This means it has a small amount of radioactive material that is designed to go directly to the cancer cells. It works because many kidney cancer cells have a specific protein on their surface called PSMA. The 177Lu-PSMA-617 attaches to this protein, bringing the radiation right to the cancer, which helps to kill those cells while trying to leave healthy cells alone. This type of treatment has already been successfully used for advanced prostate cancer, so researchers want to see if it can also help people with kidney cancer.

The main reasons for this study are to find out two key things: first, if 177Lu-PSMA-617 can shrink or stop the growth of kidney cancer, and second, to understand if it's a safe treatment. To find this out, participants will have scans and blood tests throughout the study. Researchers will also collect tissue samples to learn more about kidney cancer and hopefully find ways to identify earlier if someone's cancer is spreading or if they might benefit most from this specific treatment.

Key takeaways

New treatment for advanced kidney cancer that hasn't responded to previous therapies.
Tests a medicine called 177Lu-PSMA-617, which combines radiation with a targeting agent.
First, a scan checks if your cancer has a specific protein (PSMA) needed for the treatment to work.
Aims to see if the treatment is effective and safe for kidney cancer.
Involves regular injections, blood tests, and scans over approximately two years.
May offer a new option where other treatments are limited.

Who may be eligible?

To be part of this study, you generally need to be an adult (at least 18 years old) who has been diagnosed with advanced kidney cancer that has spread. Your cancer must have previously been treated with at least one type of immunotherapy and a targeted therapy, and despite these treatments, the cancer has continued to progress.

An important step to join the study is to have a special scan, called a PET scan. This scan checks if your kidney cancer cells have enough of a specific protein called PSMA on their surface. The new treatment, 177Lu-PSMA-617, needs this protein to work effectively, so only those who test positive for PSMA on their cancer cells can take part. You should also generally be well enough to carry out your daily activities.

There are also some medical checks, including blood tests, to make sure you are healthy enough to receive the treatment. For women who could become pregnant, a negative pregnancy test is required. The medical team will discuss all these points with you to confirm if this study might be suitable for your situation.

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 an adult (18 or older)?
Do you have advanced kidney cancer that has spread?
Has your cancer progressed after immunotherapy and targeted therapy?
Are you generally well enough for daily activities?
Are you willing to have a scan to check for the PSMA protein on your cancer cells?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first have a special scan (PET scan) to confirm your cancer has the PSMA protein. If positive, you will receive the study medicine, 177Lu-PSMA-617, as an injection into a vein. This treatment will be given about every six weeks, for a maximum of six times.

Throughout the study, you'll have regular blood tests to check your health and quickly spot any side effects. You will also have various scans before, during, and after treatment to see how well the treatment is working and how your cancer is responding. After your treatments finish, you'll have follow-up visits every six weeks for the first year, and then your doctor will decide how often you need to come in during the second year. These appointments are really important to monitor your health and the long-term effects of the treatment. The entire study period, from joining to the final follow-up, will last about two years.

Potential risks and benefits

Participating in this study offers the chance to try a new treatment (177Lu-PSMA-617) that has shown good results in prostate cancer but is new for kidney cancer. This could potentially help slow down or shrink your kidney cancer, especially if other treatments haven't worked well. However, like all new treatments, there are potential risks and side effects. These can include feeling tired, sickness (nausea), dry mouth, loss of appetite, and changes in your blood cell counts. The study team will closely monitor you for any side effects, and while they want to find out how well it works and if it's safe, some things are still unknown. Remember, you have the right to withdraw from the study at any time.

Locations (2)

Centre Francois Baclesse (CLCC)
Verified postcode
Caen, France· Recruiting
Gustave Roussy
Verified postcode
Villejuif, France· Recruiting

Common questions

What is advanced kidney cancer?

Advanced kidney cancer means the cancer has spread from your kidney to other parts of your body.

What is 177Lu-PSMA-617?

It's a new type of medicine that uses a small amount of radiation to target and kill kidney cancer cells that have a specific protein called PSMA.

How do I know if my cancer has the PSMA protein?

You'll have a special scan called a PET scan before starting the treatment to check for this protein on your cancer cells.

How long will I be in the study?

The full study, including treatments and follow-up visits, will last about two years.

Can I stop participating in the study if I want to?

Yes, you are free to leave the study at any time, for any reason.

How to find out more

EORTC

eortc@eortc.org +3227741611 Official trial record

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