RecruitingPhase IInterventional

A trial testing the safety and effectiveness of treating patients with kidney cancer that has spread to other parts of the body with a tumour freezing treatment (called cryoablation) and immunotherapy

This study is for people with advanced kidney cancer that has spread. We are investigating a new way to help the body's immune system fight the cancer more effectively. Currently, immune-boosting medicines (immunotherapy) are used, but they don't work for everyone. This trial combines immunotherapy with a treatment called cryoablation, which involves freezing cancer cells. The idea is that freezing the cancer not only kills some cells, but also helps the immune system recognise and attack the remaining cancer better. We want to see if this combination is safe and more effective than immunotherapy alone. It aims to improve how we treat advanced kidney cancer in the future.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

University of Leeds

Enrolment target

Start

01 May 2026

Estimated completion

30 Aug 2027

Metastatic renal cell carcinoma

What is this study about?

When kidney cancer spreads to other parts of the body, it can be very challenging to treat. Doctors often use a type of medicine called immunotherapy, which works by boosting your body's natural defence system – your immune system – to find and destroy cancer cells. However, for about a quarter of people, these medicines don't work, and many patients find their cancer spreads further within a year. These treatments can also cause side effects like tummy upsets, skin rashes, and breathing problems.

This study explores a new approach to make treatments for advanced kidney cancer work better. We believe that by combining immunotherapy with another treatment called cryoablation, we can improve the immune system's ability to fight cancer. Cryoablation involves freezing cancer cells by carefully inserting small needles into the tumour, guided by X-rays. We know this treatment kills cancer cells, but it also seems to "wake up" the immune system, helping it to recognise the cancer as a threat. We hope that this "wake-up call" from cryoablation, followed by immunotherapy, will lead to a stronger and more effective attack on the cancer.

This is a Phase 1 study, which means it’s one of the first times this combination is being tested in people. Our main goal is to check if it's safe to combine cryoablation with the standard immunotherapy medicines (called nivolumab and ipilimumab) for people with advanced kidney cancer. We will also carefully watch for any side effects and see how people respond to the treatment. This research will help us understand more about how these treatments work together and could lead to better treatments for kidney cancer in the future.

Key takeaways

The study combines a freezing treatment (cryoablation) with immunotherapy for advanced kidney cancer.
It aims to make the body's immune system better at fighting cancer.
This is a Phase 1 study, focusing on safety and initial effectiveness.
Participants will receive standard immunotherapy plus the freezing treatment.
There are potential benefits for future patients, but no guarantee of direct personal benefit.
It involves regular hospital visits and monitoring.

Who may be eligible?

This study is looking for adults aged 18 or over who have kidney cancer that has spread to other parts of the body. You need to have been diagnosed with a specific type of kidney cancer called clear cell renal cell carcinoma, or a type that has this component.

Your general health needs to be good enough to take part, and you must already be considered suitable for standard immunotherapy treatment with nivolumab and ipilimumab. Importantly, at least one of your cancer tumours must be in a position where doctors can safely treat it with the freezing method (cryoablation).

There are also some health requirements, such as certain blood test results falling within a healthy range, and women who could become pregnant and men whose partners could become pregnant must be willing to use effective contraception during and for a period after 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.

Are you 18 years old or older?
Do you have kidney cancer that has spread?
Has your doctor said you are suitable for standard immunotherapy (nivolumab and ipilimumab)?
Is at least one of your tumours in a place that can be safely frozen?
Are your recent general health and blood test results within healthy ranges?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive two types of treatment: immunotherapy medicines (nivolumab and ipilimumab) and cryoablation (the freezing treatment). The cryoablation treatment involves undergoing a general anaesthetic, meaning you'll be asleep for the procedure where doctors will freeze one of your tumours.

Throughout the study, you will have regular hospital appointments, which will be more frequent than if you were receiving standard care. These visits are important for us to closely monitor your health, check for any possible side effects from the treatments, and see how your body is responding. We will also perform various tests, such as blood tests and scans, to understand the effects of the treatment on your cancer and your immune system. The study is expected to run from May 2026 to June 2028, and your participation duration will depend on your individual treatment plan and follow-up needs.

Potential risks and benefits

The main benefit we hope for is that combining freezing treatment with immunotherapy will make the cancer treatment more effective than immunotherapy alone. It might increase the chances of the treatment working for you. However, it’s important to know that we don't know for sure if it will help you personally. Your participation is definitely valuable for improving future cancer treatments. While immunotherapy has known side effects like diarrhoea, rashes, or breathing problems, the additional risks come from the freezing treatment. This procedure requires a general anaesthetic and carries a small risk of bleeding, pain, or infection. You will be closely monitored by our team, 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.

Leeds Teaching Hospitals NHS Trust
City only
Leeds, England

Common questions

What is advanced kidney cancer?

This means kidney cancer that has spread from the kidney to other parts of the body.

What is immunotherapy?

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

What is cryoablation?

This is a treatment where doctors freeze cancer cells in a tumour using special needles and X-ray guidance.

Will I have to pay to be part of the study?

No, all treatments and tests directly related to the study will be covered.

How long will the study run for?

The study itself is expected to run from May 2026 to June 2028, and your involvement will depend on your individual treatment journey.

How to find out more

Marta Kurzawa

marta.kurzawa@nhs.net - Official trial record

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