A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) versus Placebo as Adjuvant Therapy in Participants with Hepatocellular Carcinoma and Complete Radiological Response after Surgical Resection or Local Ablation (KEYNOTE-937)
This study is investigating a new treatment called Keytruda (pembrolizumab) for liver cancer (hepatocellular carcinoma) after it has been removed by surgery or local treatments. The aim is to see if Keytruda can prevent the cancer from returning and improve how long people live, compared to a dummy treatment (placebo). It's a 'double-blind' study, meaning neither the patient nor their doctor will know if they are receiving Keytruda or the placebo. Researchers will compare how well both groups do over time. They will also check for any side effects and how the treatment affects quality of life. This is a large, important study in the final stages of testing before a treatment might become more widely available.
At a glance
What is this study about?
Imagine you've had an operation or treatment to remove liver cancer. That’s great news! Now, doctors are looking for ways to stop the cancer from coming back. This study is testing if a medicine called Keytruda can help with that. Keytruda is a type of 'immunotherapy,' which means it helps your body's own immune system fight cancer cells.
In this study, some people will receive Keytruda, and others will receive a 'placebo' – which looks just like the real medicine but contains no active drug. This is done to fairly compare the new treatment against doing nothing extra. Neither you nor your study doctor will know which one you are getting. This helps make sure the results are as fair and accurate as possible.
The main things the researchers want to find out are whether Keytruda helps people stay cancer-free for longer and if it helps people live longer overall. They will also carefully monitor side effects and look at how the treatment impacts your daily life and well-being. This information will help doctors understand if Keytruda is a good treatment option for preventing liver cancer from returning.
Key takeaways
- This study is testing a new treatment, Keytruda, for liver cancer.
- It aims to prevent cancer recurrence after surgery or local treatment.
- You might receive Keytruda or a placebo (dummy treatment).
- Your health and quality of life will be closely monitored.
- The study seeks to improve outcomes for liver cancer patients.
Who may be eligible?
To join this study, people need to be at least 18 years old and have been diagnosed with a type of liver cancer called hepatocellular carcinoma.
Critically, your liver cancer must have been completely removed, either by surgery or by another treatment that aimed to destroy the cancer cells (like using heat or freezing). The doctors need to confirm that after this procedure, there are no signs of cancer left in your body on scans and tests.
Both men and women can take part in this study. There will be other specific health checks and tests to make sure that taking part is safe for you and that you meet all the study requirements.
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 at least 18 years old?
- Have you been diagnosed with hepatocellular carcinoma (a type of liver cancer)?
- Has your liver cancer been completely removed by surgery or another procedure?
- Are there currently no signs of cancer in your body after your treatment?
What does participation involve?
If you decide to take part, you would receive either the study drug (Keytruda) or a placebo, given through a drip (infusion) into your vein. This treatment would be given over a period of time, and you would have regular appointments at the hospital or clinic. These appointments would involve physical examinations, blood tests, and scans to track your health and check if the cancer has returned. You'll also be asked to complete questionnaires about your quality of life.
The study would involve regular visits over many months, potentially even a couple of years for the treatment phase. After the treatment period, there would be a follow-up phase where researchers continue to monitor your health and any signs of the cancer returning, which could last for several years. The total length of your involvement would be explained in detail by the study team.
Potential risks and benefits
Locations (11)
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedSweden
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedDenmark
- —UnverifiedNorway
- —UnverifiedIreland
- —UnverifiedPoland
Common questions
What is Keytruda?
Keytruda is a medicine that helps your body’s immune system find and fight cancer cells.
What is a 'placebo'?
A placebo is like a dummy treatment; it looks just like the real medicine but doesn't contain any active drug. It helps researchers compare treatments fairly.
What does 'double-blind' mean?
It means neither you nor your study doctor will know whether you are receiving Keytruda or the placebo. This helps prevent bias in the study results.
Why is this study important?
It aims to find out if Keytruda can help stop liver cancer from coming back after treatment and potentially help people live longer.
Will I have to pay to be in the study?
No, treatments and study-related assessments will be provided at no cost to you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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