A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630).
This study is looking at a new treatment called Pembrolizumab (also known as Keytruda) for a type of advanced skin cancer called cutaneous squamous cell carcinoma. People who have had surgery and radiation for their cancer will either receive Keytruda or a dummy treatment (placebo). The main aim is to see if Keytruda can stop the cancer from coming back. We will also be looking at how long people live, their quality of life, and any side effects. This is a Phase 3 study, meaning it's a large trial to confirm if the treatment is safe and effective.
At a glance
What is this study about?
Imagine you've had surgery and radiotherapy for a type of skin cancer called cutaneous squamous cell carcinoma, which has grown quite a bit. Doctors have removed it, but there's always a worry it might come back. This study is testing if a medicine called Keytruda can help prevent 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 after their surgery and radiation, while others will receive a 'placebo' – this looks like the real medicine but contains no active drug. This helps doctors fairly compare whether Keytruda makes a difference. Neither you nor your doctor will know if you're getting Keytruda or the placebo until the end of the study. The main thing they're looking at is how long people stay cancer-free after their treatment.
But it's not just about stopping the cancer from returning. The study also wants to understand how people feel during and after treatment. They'll look at your overall health and how it affects your daily life, and carefully check for any side effects. This research is important because it could lead to new ways of helping people with advanced skin cancer stay well for longer.
Key takeaways
- Tests Keytruda after surgery and radiation for advanced skin cancer.
- Main goal: Stop cancer from returning.
- Some people get Keytruda, some get a dummy treatment (placebo).
- Looks at how you feel and any side effects.
- You'll have regular hospital visits and check-ups.
- Participation is voluntary and you can leave at any time.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or over. This study is for people who have been diagnosed with a type of skin cancer called cutaneous squamous cell carcinoma that has grown locally (hasn't spread far) and is considered 'high-risk'.
Crucially, you must have recently had surgery to remove your cancer, followed by radiotherapy (radiation). The surgeons must feel confident that they have removed all the visible cancer cells. The study will consider both men and women.
There will also be other medical checks to make sure the treatment is safe for you, such as checking your kidney and liver function, and that you generally meet other health criteria to participate in a clinical trial.
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 high-risk locally advanced cutaneous squamous cell carcinoma?
- Have you recently had surgery to remove your cancer?
- Have you recently completed radiation treatment for your cancer?
- Are you well enough to participate in a clinical study?
What does participation involve?
If you decide to join this study, you will be assigned to either receive the study drug (Keytruda) or a placebo (a dummy drug). You'll receive these treatments through an IV drip, typically every three weeks for up to about a year. You will have regular hospital visits for these treatments and for check-ups.
These visits will involve physical examinations, blood tests, and scans (like CT or MRI scans) to see how you're doing and if the cancer has returned. You'll also be asked to complete questionnaires about your quality of life and how you're feeling. After the treatment period, you'll have follow-up visits for several years to keep track of your health and see if the cancer comes back. The total duration of active treatment is around one year, but follow-up could last for several years.
Potential risks and benefits
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Common questions
What is cutaneous squamous cell carcinoma?
It's a common type of skin cancer that starts in the flat cells on the surface of your skin. 'High-risk locally advanced' means it has grown into nearby tissues but hasn't spread widely in the body yet.
What is Keytruda?
Keytruda (also called Pembrolizumab) is a cancer medicine that helps your body's immune system recognise and fight cancer cells. It's given through a drip into your vein.
What does 'placebo' mean?
A placebo is a dummy treatment that looks just like the real medicine but doesn't contain any active drug. It helps doctors compare the real medicine against not having it.
Why don't I know if I'm getting Keytruda or the placebo?
This is called a 'double-blind' study. Neither you nor your doctors will know, so that the results are fair and not influenced by anyone's expectations. This helps get accurate results.
How long will I be in the study?
The active treatment phase lasts for about a year. After that, you'll have regular follow-up checks for several years to monitor your health and ensure the cancer hasn't come back.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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