RecruitingPhase IIIInterventional

Randomised study platform to optimize treatment in patients with metastatic renal cell carcinoma

This study is for people with advanced kidney cancer (renal cell carcinoma) that has spread. Doctors are investigating different combinations of existing treatments. These treatments generally fall into two main groups: drugs that boost your immune system to fight cancer, and 'targeted therapies' that block signals helping tumours grow. The aim is to find out if certain combinations work better for different patients, based on a specific test called PDL1. The study hopes to improve how long people live and stop the cancer from getting worse. It's an important step in making kidney cancer treatment more personal and effective.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Institut Gustave Roussy

Enrolment target

1,250

Start

11 Apr 2024

Estimated completion

31 Mar 2027

Metastatic renal cell carcinoma

What is this study about?

Kidney cancer can sometimes spread to other parts of the body, which doctors call 'metastatic'. When this happens, doctors often use a mix of powerful medicines to treat it. There are generally two main types of drugs used: those that help your own immune system fight the cancer (immunotherapy) and 'targeted therapies' that work by blocking specific signals that help cancer cells grow and multiply. Think of targeted therapies like stopping the cancer's food supply.

At the moment, combining these treatments is the standard approach for a common type of kidney cancer. This study, called CARE-1, is a really important step in working out the best way to combine these treatments. It's looking to see if two immunotherapy drugs together work better for people whose cancer cells show a marker called PDL1. For those whose cancer doesn't show this marker, the study wants to see if a combination of one immunotherapy drug and a targeted therapy is more effective at slowing down the cancer's growth and helping people live longer.

The exciting part is that the study uses a 'randomised platform'. This means that while doctors decide which combination to use based on your individual cancer's characteristics (like that PDL1 marker), the study is set up to gather clear information on which treatments are most effective for whom. The goal is to make future treatments for advanced kidney cancer even more tailored and successful, giving patients the best possible chance.

Key takeaways

This study evaluates existing drug combinations for advanced kidney cancer.
It aims to find the most effective treatments based on cancer characteristics like PDL1.
The treatments involve immune-boosting drugs and/or targeted therapies.
It hopes to improve survival and stop cancer from growing.
Participation involves routine care with close monitoring.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have kidney cancer that has spread, specifically with a 'clear-cell' type. Doctors would also need to have classified your cancer as 'intermediate' or 'poor-risk' based on certain factors. You'd also need to be generally well enough to take part, meaning you can carry out most daily activities and your body's main organs (like your liver, kidneys, and blood) are working well.

There are also some important checks to make sure the study is safe for you. For example, if you're a woman who could become pregnant, you'd need to have a negative pregnancy test and agree to use effective contraception during the study and for a period afterwards. Men with partners who could become pregnant would also need to agree to use contraception.

You wouldn't be able to join this study if you've already had certain kinds of treatment for your advanced kidney cancer. The doctors will also check other health conditions to make sure the study is the right fit for you.

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 over?
Do you have kidney cancer that has spread, specifically the 'clear-cell' type?
Has your doctor classified your cancer as 'intermediate' or 'poor-risk'?
Are you generally well and able to carry out most daily activities?
Are your main organs (like liver, kidneys) working well?
Have you not had previous systemic treatment for advanced kidney cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your doctors will decide which combination of existing treatments is most suitable for you, based on your cancer's characteristics. This study uses treatments that are already known and used by doctors for kidney cancer. There aren't extra tests or procedures beyond what you would usually have for your care.

You'll have regular hospital visits, just like you would for standard treatment, where doctors will monitor your health and how the treatment is working. This will involve blood tests and imaging scans (like CT scans) to check the cancer. The study will run until September 2029, and you'll be part of it for as long as your treatment continues, followed by a period where doctors will monitor your health to see how you're doing in the long term.

Potential risks and benefits

Taking part in this study means you'll receive treatments that your doctor believes are right for your condition. A potential benefit is contributing to research that could help improve future treatments for people with kidney cancer. However, it's important to understand that there aren't guaranteed personal benefits beyond receiving care. All medications and procedures have potential side effects and risks, which your doctor will explain in detail. These risks are generally the same as those associated with these treatments outside of a study, such as potential pain from blood tests or anxiety from scans. You will be closely monitored, and you have the right to withdraw from the study at any time, for any reason, without affecting your regular medical care.

Locations (10)

Queen Mary University of London
Approximate
London, England
Churchill Hospital
Approximate
Oxford, England
Mount Vernon Cancer Centre
City only
Northwood, England
Edinburgh Cancer Centre
Approximate
Edinburgh, Scotland
Nottingham City Hospital
City only
Nottingham, England
The Christie NHS Foundation Trust
City only
Manchester, England
Royal Free London NHS Foundation Trust
City only
London, England
Cambridge University Hospitals
Approximate
Cambridge, England
Guy's and St Thomas
City only
London, England
Imperial College
Approximate
London, England

Common questions

What is 'metastatic' kidney cancer?

This means the kidney cancer has spread from where it started to other parts of your body.

What does PDL1-positive or PDL1-negative mean?

PDL1 is a marker found on some cancer cells. Testing for it helps doctors predict which type of treatment might work best for you.

Are the study treatments new drugs?

No, the study uses combinations of existing, approved drugs for kidney cancer. It's looking for the best way to use them.

Will I get extra tests if I join this study?

Not usually. The study mainly uses the same kinds of tests and procedures that are part of your routine care for advanced kidney cancer.

Who is paying for this study?

The study is funded by the HORIZON EUROPE Programme, which is a big research and innovation programme in Europe.

How to find out more

Charlotte Ackerman

bci-care1@qmul.ac.uk - Official trial record

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