AuthorisedTherapeutic exploratory (Phase II)Interventional

Neoadjuvant AXITINIB plus AVELUMAB for patients with localized RCC and a moderate to high risk of recurrence (N17JAV)

This research study is investigating two medications, axitinib (Inlyta) and avelumab (Bavencio), given together before surgery to treat a type of kidney cancer called renal cell carcinoma. This specific cancer is localised, meaning it hasn't spread, and carries a moderate to high risk of coming back after treatment. Researchers want to find out how effective this drug combination is at shrinking the cancer before an operation. They are also carefully checking for any side effects and looking at long-term results, such as how long people live without the cancer returning or spreading. This is an early-stage study, aiming to understand the treatment's potential.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Enrolment target

Start

11 Jul 2024

renal cell carcinoma

What is this study about?

This study is looking into a new way to treat kidney cancer, specifically a type called renal cell carcinoma. This cancer is currently localised, meaning it's only in the kidney and hasn't spread to other parts of the body. However, doctors believe it has a moderate to high chance of returning after initial treatment. The research focuses on giving two specific medications, axitinib (also known as Inlyta) and avelumab (also known as Bavencio), *before* surgery.

The main idea behind giving these drugs before an operation, a process called 'neoadjuvant' treatment, is to try and shrink the tumour as much as possible. If the tumour is smaller, it might make the surgery easier or more effective. The study wants to see how many people experience a significant reduction in their tumour size after taking this drug combination. This is considered the primary goal.

Beyond just shrinking the tumour, the researchers are also very keen to understand the safety of this drug combination. They will be closely monitoring any side effects that people experience. They will also track what happens to patients over a longer period, looking at how long they remain free of cancer, how long they live, if the cancer spreads, or if it comes back in the same area. This will help doctors understand if this new treatment approach could be a more effective way to manage this type of kidney cancer in the future.

Key takeaways

This study evaluates two drugs (axitinib and avelumab) given before surgery for kidney cancer.
It's for localised kidney cancer that has a higher chance of coming back.
The main aim is to see how well the treatment shrinks the cancer.
Researchers will also carefully watch for side effects and long-term results.
This is an early-stage study to understand the treatment's potential.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women are welcome to take part. The study is specifically for people who have been diagnosed with renal cell carcinoma, which is a type of kidney cancer.

Critically, the cancer must be 'localised', meaning it is found only in the kidney and hasn't spread to other parts of the body. Doctors also need to believe that this kidney cancer has a moderate to high chance of returning after treatment.

There might be other specific health requirements or conditions that would prevent someone from joining, even if they meet these general criteria. These details would be discussed fully by the study team and your doctor.

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?
Have you been diagnosed with renal cell carcinoma (a type of kidney cancer)?
Is your kidney cancer localised (only in the kidney, not spread)?
Has your doctor told you your kidney cancer has a moderate to high risk of returning?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medications, Bavencio (given as an infusion into a vein) and Inlyta (taken as tablets), before your scheduled surgery. You will have regular visits to the clinic or hospital, where the study team will monitor your health, check for any side effects, and assess how the treatment is affecting your cancer. These assessments will involve various tests, scans, and physical examinations.

After your surgery, the study team will continue to follow your progress for a long period. This follow-up will involve regular check-ups to see if the cancer returns, spreads, or if you develop any long-term issues. The total duration of your active treatment period before surgery and the subsequent follow-up period will be explained in detail by the study team.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. You might benefit if the new drug combination helps shrink your cancer more effectively than standard treatment before surgery. However, there's no guarantee it will work for everyone, and it's possible you will not experience any direct benefit. As with all medications, there's a risk of side effects, which the study team will monitor closely. You will be told about all known possible side effects before you decide to take part. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Netherlands

Common questions

What is 'neoadjuvant' treatment?

Neoadjuvant treatment means getting medicine or therapy before your main surgery to help prepare for it, often by shrinking the tumour.

What is renal cell carcinoma?

It's the most common type of kidney cancer. 'Localized' means it's still contained within the kidney.

What are axitinib and avelumab?

These are the names of the two specific drugs being tested together in this study. They are types of cancer therapies.

Is this a new treatment?

Yes, combining these two drugs in this way before surgery for this type of kidney cancer is an investigational approach being studied.

What is a 'partial remission'?

In this study, partial remission means the tumour has shrunk by a certain amount after treatment, but it hasn't completely disappeared.