Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Axitinib versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)

This study, called KEYNOTE-426, is for people with kidney cancer that has spread, or is advanced. It aims to find out if a new treatment combination, pembrolizumab (Keytruda) with axitinib, is more effective and safer than a current standard treatment, sunitinib. Researchers will be looking at how long people live without their cancer getting worse, and how long they live overall. They'll also check how many people respond to the treatments, how long those responses last, and importantly, any side effects people might experience. This is a Phase 3 study, meaning it's a large trial designed to confirm if a new treatment works better than an existing one.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

269

Start

14 Dec 2023

Metastatic renal cell carcinoma

What is this study about?

This study is about finding better ways to treat a type of kidney cancer called advanced renal cell carcinoma. This means the cancer has spread from where it started, or it is too advanced to be removed with surgery. When doctors look for new treatments, they want to know two main things: how well the treatment works to fight the cancer, and how safe it is for the patient.

In this study, two groups of patients are compared. One group will receive a combination of two medicines, pembrolizumab (which you might know as Keytruda) and axitinib. The other group will receive sunitinib, which is a common treatment for this type of cancer already. By comparing these groups, doctors can see if the new combination offers a better chance of fighting the cancer or fewer side effects.

The main things the doctors will be watching closely are how long people live without their cancer getting worse, and how long they live overall. They will also look at whether the tumours shrink and for how long. Importantly, they will record any side effects to understand the safety of the treatments and how they affect your quality of life. This research is crucial to help doctors decide on the best treatment options for future patients.

Key takeaways

The study compares a new drug combination to a standard treatment for advanced kidney cancer.
It's for people newly diagnosed with advanced kidney cancer.
Both treatment effectiveness and safety will be carefully monitored.
This is a large study (Phase 3) to see if the new combination is better.
Participants will have regular check-ups, scans, and blood tests.
You can discuss with your doctor if this study might be suitable for you.

Who may be eligible?

To be part of this study, you generally need to be an adult, aged 18 or older. Both men and women can take part.

This study is specifically for people who have been diagnosed with kidney cancer that has spread to other parts of the body, or is locally advanced. This is often described as 'metastatic' renal cell carcinoma. It's important that this is your first time being treated for this advanced kidney cancer, meaning you haven't received other treatments for it yet.

There might be other specific health requirements or conditions that would mean you can or cannot join the study. If you're interested, your doctor will be able to check all the details to see if this study is right 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 older?
Do you have advanced kidney cancer?
Have you not yet received any treatment for your advanced kidney cancer?
Are you considering a new treatment option for your condition?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be given either the combination of pembrolizumab and axitinib, or sunitinib. Which treatment you receive is decided randomly, like flipping a coin, so neither you nor your doctor can choose. You will receive these medicines as prescribed by the study doctors.

Throughout the study, you'll have regular hospital visits for check-ups. These visits will involve various tests, including blood tests and scans (like CT or MRI scans), to see how the treatment is working and to monitor your health. Doctors will also ask you about any side effects you might be experiencing.

You'll also be asked to complete questionnaires about your quality of life and how you're feeling. The study will continue for a period, during which your health will be closely monitored. Even after treatment stops, there will likely be follow-up appointments to track your long-term health and outcomes.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study is that you might receive a new treatment combination that could be more effective than standard treatment. This study helps doctors learn more, which could help future patients. However, there's no guarantee the treatment will work for you, and it might not be better than existing treatments. Like all medicines, the study treatments can cause side effects, which could range from mild to serious. The study team will monitor you very closely for any side effects and support you throughout. Remember, deciding whether to join is entirely your choice, and you can withdraw from the study at any time without it affecting your usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Ireland
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Unverified
Hungary
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Unverified
Czechia
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Unverified
Germany
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Unverified
Spain
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Unverified
France
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Unverified
Poland

Common questions

What is 'advanced' kidney cancer?

Advanced kidney cancer means the cancer has spread from the kidney to other parts of your body, or it's grown significantly in the area around the kidney.

What are pembrolizumab, axitinib, and sunitinib?

These are different medicines used to treat kidney cancer. Pembrolizumab helps your body's immune system fight the cancer. Axitinib and Sunitinib work by blocking signals that help cancer cells grow.

What does 'Phase 3' mean for a study?

Phase 3 means this is a large study that compares a new treatment with an existing one. Its goal is to confirm if the new treatment is better than what's currently available.

What does 'first-line treatment' mean?

First-line treatment means this is the first treatment you would receive for your advanced kidney cancer, before trying any other medicines for this condition.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, which means both you and your doctor will know which treatment you are receiving (either the combination or sunitinib).