RecruitingPHASE2INTERVENTIONAL

Axitinib +/- Pembrolizumab in First Line Treatment of mPRCC

This study is for people in the UK with a specific type of kidney cancer called metastatic papillary renal cell carcinoma type 2 (PRCC type 2). This cancer has spread to other parts of the body or can't be removed by surgery. Doctors are trying to find better ways to treat it, as current treatments often aren't very effective. This study will test two drugs, Axitinib (brand name Inlyta) and Pembrolizumab (brand name Keytruda). Both are already approved for other cancers. Researchers want to see if using these drugs, either separately or combined, can help slow down or stop the growth of PRCC type 2. It's a Phase 2 trial, meaning it's still in the earlier stages of finding out how well these treatments work.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre Leon Berard

Enrolment target

Start

01 Jun 2022

Estimated completion

01 Jun 2026

Papillary Renal Cell Carcinoma Type 2

What is this study about?

This research study is focused on a type of kidney cancer called papillary renal cell carcinoma (PRCC), specifically type 2. While PRCC is less common than other kidney cancers, type 2 tends to have a more challenging outlook, especially when it has spread (which doctors call metastatic or locally advanced disease). Currently, there isn't one best treatment specifically designed for this type of cancer, so doctors often use treatments that are approved for other kidney cancers. This is why it's really important to find new and more effective options.

The study is looking at two medicines: Axitinib (also known as Inlyta) and Pembrolizumab (also known as Keytruda). Axitinib works by blocking certain signals that help cancer cells grow and form new blood vessels. Pembrolizumab is an immunotherapy that helps your own immune system fight the cancer. Both of these drugs are already used to treat other types of cancer, but doctors want to see how well they work for PRCC type 2.

The aim of the study is to see if these drugs, used either on their own or together, can help control the cancer, slow its growth, or even shrink it. By taking part in studies like this, patients can help doctors learn more about PRCC type 2 and potentially discover new and better treatments for future patients.

Key takeaways

Targets advanced papillary renal cell carcinoma type 2.
Tests Axitinib and Pembrolizumab, alone or combined.
Aims to find effective new treatment options.
No prior systemic kidney cancer treatment allowed.
Requires careful monitoring and regular hospital visits.

Who may be eligible?

You might be able to take part in this study if you are 18 years old or older and have a specific type of kidney cancer called metastatic or locally advanced papillary renal cell carcinoma type 2. This means your cancer has spread or cannot be removed by surgery. Your cancer type will need to be confirmed by experts.

It's important that you haven't received any previous drug treatments for your kidney cancer, such as chemotherapy, immunotherapy, or other targeted treatments. You also need to have at least one spot of cancer that can be measured by scans, and generally be well enough to take part in the study, which doctors gauge using a score called ECOG Performance Status.

There are also some health requirements regarding your blood, liver, and kidney functions, which your doctor will test. You cannot have significant protein in your urine. If you've had radiation treatment recently, there are specific timeframes you'd need to meet before joining.

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 metastatic or advanced papillary renal cell carcinoma type 2?
Have you not had any prior drug treatment for your kidney cancer?
Are you generally well enough for treatment, as judged by your doctor?
Do your blood, liver, and kidney test results meet certain levels?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be given either Axitinib, Pembrolizumab, or both. Your doctors will explain exactly what your treatment plan will be. Axitinib is a tablet you take by mouth, and Pembrolizumab is given as an injection, usually through a vein. You will have regular visits to the hospital or clinic for these treatments and to have checks on your health.

During these visits, you'll have blood tests, urine tests, and scans (like CT scans) to see how you are responding to the treatment and to keep an eye on any side effects. You'll work closely with the study team, and they'll monitor your progress. The total length of your participation will depend on how the treatment works for you and other factors, and the study team will discuss this in detail.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments before they are widely available and close monitoring by a medical team. However, there are also risks. The experimental treatments might have side effects, which can vary from mild to severe, and they might not work for everyone. Your doctor will discuss all known and potential side effects with you in detail. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

Ico - Paul Papin
Verified postcode
Angers, France· Not yet recruiting
CHU de BESANCON
Verified postcode
Besançon, France· Not yet recruiting
Chu Bordeaux
Verified postcode
Bordeaux, France· Recruiting
Centre Jean Perrin
Verified postcode
Clermont-Ferrand, France· Not yet recruiting
Centre Leon Berard
Verified postcode
Lyon, France· Recruiting
Institut Paoli-Calmettes
Verified postcode
Marseille, France· Recruiting
Centre Antoine Lacassagne
Verified postcode
Nice, France· Recruiting
Ap-Hp Hôpital Europeen Georges Pompidou
Verified postcode
Paris, France· Not yet recruiting
Ico-Rene Gauducheau
Verified postcode
Saint-Herblain, France· Not yet recruiting
Iuct-Oncopole Institut Claudius Regaud
Verified postcode
Toulouse, France· Recruiting
Institut de Cancerologie de Lorraine - Alexis Vautrin
Verified postcode
Vandœuvre-lès-Nancy, France· Recruiting
Gustave Roussy
Verified postcode
Villejuif, France· Recruiting

Common questions

What is papillary renal cell carcinoma type 2?

It's a less common type of kidney cancer, and type 2 means it has specific features under the microscope. This study focuses on cases where the cancer has spread or can't be operated on.

What are Axitinib and Pembrolizumab?

Axitinib (Inlyta) helps block signals that cancer cells need to grow. Pembrolizumab (Keytruda) is an immunotherapy that helps your body's immune system fight the cancer. Both are already used for other cancers.

Why is this study important?

There isn't a standard, highly effective treatment specifically for metastatic papillary renal cell carcinoma type 2, so this study aims to find better options for patients.

What 'phase' is this study?

This is a Phase 2 study, which means it's one of the earlier steps in testing a new treatment. Doctors are looking at how safe the treatment is and how well it works.

Will I definitely get both drugs?

The study will test both drugs, either alone or combined, and the specific treatment you receive will be part of the study design, which the doctors will explain to you.

How to find out more

Sylvie NEGRIER

sylvie.negrier@lyon.unicancer.fr 0478782751 Official trial record

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