Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Study evaluating PSMA targeted radionuclide therapy in adult patients with metastatic clear cell renal cancer

This research study is investigating a new treatment approach for adults with a type of kidney cancer called clear cell renal cancer that has spread to other parts of the body (metastatic). Specifically, it's for patients whose cancer has continued to grow even after they've had at least two different types of treatment, including treatments that target blood vessel growth (anti-VEGFR) and treatments that boost the body's immune system (immunotherapy). The new treatment involves using a targeted radionuclide therapy, which is a type of radiation that aims directly at cancer cells. The study will look at how safe and effective this new treatment is for these patients.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Centre Leon Berard, Centre Leon Berard

Enrolment target

Start

11 Aug 2023

metastatic clear cell renal cancer with progressive disease after 2 lines of therapy in the advanced/metastatic setting including at least 1 line of anti-VEGFR and 1 line of immunotherapy.

What is this study about?

This study is focused on a specific type of kidney cancer called clear cell renal cancer, which has spread to other parts of the body. When cancer spreads, doctors call it 'metastatic'. For patients with this type of advanced cancer, doctors often try different treatments to help manage it. This study is for people who have already tried at least two common types of treatment, and unfortunately, their cancer has continued to grow. These previous treatments likely included medicines that stop new blood vessels from feeding the cancer (called anti-VEGFR therapy) and treatments that help your own immune system fight the cancer (called immunotherapy).

The new treatment being tested in this study is a 'PSMA targeted radionuclide therapy'. In simpler terms, this is a special type of radiation treatment. It works by using a substance that specifically sticks to kidney cancer cells (guided by something called PSMA) and then delivers a small dose of radiation directly to those cells. The idea is to target the cancer more precisely while affecting healthy cells less.

This study has two main parts, Phase I and Phase II, which means researchers are carefully checking for both safety and whether the treatment works. They want to understand if this new targeted radiation can be a helpful option for people with this challenging form of kidney cancer that hasn't responded well to other therapies.

Key takeaways

This study is for adults with advanced clear cell kidney cancer.
It's for patients whose cancer has grown despite previous treatments, including anti-VEGFR and immunotherapy.
The study is testing a new type of targeted radiation treatment.
It aims to see if this new treatment is safe and effective.
Participation could offer a new treatment option but also carries known and unknown risks.

Who may be eligible?

This study is specifically designed for adults aged 18 and over, and it's open to both men and women. The key thing is that you must have clear cell kidney cancer that has spread to other parts of your body. Your cancer must also have gotten worse even after you've had at least two different types of treatment. This includes having received at least one type of medicine that targets blood vessel growth (like anti-VEGFR therapy) and one type of immune-boosting treatment (immunotherapy).

To be considered for this study, your medical team will need to confirm that your kidney cancer fits these specific criteria. They will also look at your overall health to make sure you are well enough to take part in a study like this. There will be other detailed health checks to ensure your safety if you join.

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?
Has your cancer continued to grow after at least two different treatments?
Have you had at least one type of anti-VEGFR treatment?
Have you had at least one type of immunotherapy?

Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves is not available here, as the brief summary was empty. However, in most clinical trials like this, participation generally involves regular visits to the hospital or clinic. These visits would typically include physical examinations, blood tests, and scans (like CT or MRI scans) to monitor your health and how the treatment is affecting your cancer. You would receive the study treatment, which is a targeted radionuclide therapy, likely through injections or infusions. There would also be a follow-up period after your active treatment finishes to continue monitoring your health and the long-term effects of the therapy. The total duration of your involvement could range from several months to a couple of years, depending on the study design and your personal response.

Potential risks and benefits

Taking part in a clinical trial offers the chance to be among the first to receive a new treatment that might be more effective than standard options, especially if current treatments haven't worked well for you. It also contributes to medical knowledge that could help future patients. However, there are potential risks, as new treatments can have side effects that are not yet fully known. These might include side effects related to radiation or other general treatment-related issues. You will be closely monitored for any problems, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future 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
France

Common questions

What is 'metastatic clear cell renal cancer'?

It's a type of kidney cancer that started in the kidney and has spread to other parts of your body, and the cancer cells look 'clear' under a microscope.

What does 'PSMA targeted radionuclide therapy' mean?

It's a special radiation treatment that uses a substance to find kidney cancer cells (guided by something called PSMA) and then delivers radiation directly to them.

What are 'anti-VEGFR' and 'immunotherapy'?

They are types of cancer treatments you might have had before. Anti-VEGFR treatments stop the cancer from forming new blood vessels, and immunotherapy helps your body's immune system fight the cancer.

Why is this study for people whose cancer has progressed?

This study is looking for new options for patients whose cancer has continued to grow even after trying standard treatments, including anti-VEGFR and immunotherapy.

Can I still have my regular doctor if I join the study?

Yes, you will still have your regular doctor, and the study team will work closely with them to ensure you receive the best care.