Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)

This study is testing a medication called Keytruda as a treatment for people who have had surgery for a type of kidney cancer (renal cell carcinoma). The main aim is to see if Keytruda can help prevent the cancer from returning after the operation. Participants will either receive Keytruda or a 'dummy' medicine (placebo) – neither they nor their doctors will know which one they are getting. Researchers will closely monitor how long people stay cancer-free, their overall health, and any side effects. This research helps doctors understand if Keytruda could be a new standard treatment option for kidney cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

350

Start

18 Jan 2023

Renal cell carcinoma

What is this study about?

This study, called KEYNOTE-564, is a medical research project looking into a medicine named Keytruda (the scientific name is pembrolizumab). It's designed for people who have had an operation to remove a kidney affected by kidney cancer (renal cell carcinoma). The main question the researchers want to answer is whether receiving Keytruda after surgery can help prevent the cancer from coming back.

To find this out, some people in the study will get Keytruda, and others will get an inactive substance called a placebo – often called a 'dummy medicine'. Neither the patients nor their doctors will know who is getting which treatment. This is done to make sure the results are as fair and accurate as possible, so we can clearly see if Keytruda is making a difference compared to not having this specific treatment.

The study will carefully track several important things. The main thing is to see how long people stay free of cancer after their surgery and treatment. They'll also look at overall survival, how many side effects people experience, and how the treatment affects their quality of life. All this information helps doctors decide if Keytruda should be used more widely to help people with kidney cancer.

Key takeaways

This study investigates Keytruda after kidney cancer surgery.
It aims to see if Keytruda stops the cancer from returning.
Participants will receive Keytruda or a dummy medicine.
The study monitors cancer recurrence, overall health, and side effects.
Both men and women aged 18 and over can potentially take part.
You can stop participating at any time.

Who may be eligible?

This study is looking for adult patients, 18 years and older, who have recently had surgery to remove their kidney due to kidney cancer. Both men and women can take part.

To be considered, you would need to have had a specific type of kidney cancer that has been completely removed by surgery. There will be other health checks and medical requirements to make sure the study is right and safe for you. Your doctor will be able to discuss these with you in more detail.

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 had surgery to remove a kidney for kidney cancer?
Has your doctor confirmed your kidney cancer was a specific type and completely removed?
Are you generally well enough to participate in a clinical study?

Answer every question to see your result.

What does participation involve?

If you join this study, you would primarily receive either the study medicine (Keytruda) or a dummy medicine through an infusion (a drip into your arm) over a set period. You would have regular visits to the clinic for these infusions, along with check-ups, blood tests, and scans to see how you are doing and whether the treatment is working. The exact number of visits and the total length of your participation would be explained fully by the study team, but these types of studies often involve several months to a few years of follow-up.

Potential risks and benefits

Taking part in a clinical study can have potential benefits, such as receiving a new treatment that might help your condition, as well as close monitoring by medical professionals. However, there are also potential risks, including side effects from the medication or the possibility that the treatment may not work for you. Keytruda, like all medicines, can have side effects, which would be explained to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

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

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Unverified
Netherlands
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Unverified
Poland
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Unverified
Finland
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Unverified
Spain
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Unverified
Czechia
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Unverified
Ireland
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Unverified
Italy
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Unverified
France
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Unverified
Germany

Common questions

What is Keytruda?

Keytruda is a type of medicine that helps your body's own immune system fight cancer.

Why is a 'dummy medicine' used?

The dummy medicine, or placebo, helps researchers fairly compare if Keytruda is actually making a difference compared to not having that specific new treatment.

Will I know if I'm getting the real medicine or the dummy one?

No, during the study, neither you nor your doctor will know whether you are receiving Keytruda or the dummy medicine. This is to ensure the results are unbiased.

What does 'Disease-free Survival' mean?

It means how long a person lives after treatment without the cancer coming back.

Is this a new treatment?

Keytruda is an established treatment for some cancers, but for kidney cancer after surgery, it's still being investigated in this study to confirm its benefits.