A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18 / ENGOT-cx11/GOG-3047)
This important study, known as KEYNOTE-A18, is looking at a new way to treat cervical cancer that has started to spread nearby but not to distant parts of the body (locally advanced). Researchers want to find out if adding a drug called pembrolizumab (also known as Keytruda) to the usual treatment of chemotherapy (cisplatin) and radiation therapy is more effective. The study aims to see if this combination helps patients live longer without their cancer getting worse, and improves overall survival. This is a Phase 3 study, meaning it's comparing the new treatment against the best existing treatment to see if it's better.
At a glance
What is this study about?
This study is about finding better treatments for a type of cervical cancer that has grown into nearby tissues but hasn't yet spread widely throughout the body. This is called 'locally advanced' cervical cancer. Currently, the standard treatment often involves a combination of chemotherapy and radiation therapy. This study wants to see if adding an extra drug, called pembrolizumab (you might hear it called Keytruda), to this standard treatment can make it even better. Pembrolizumab is a type of immunotherapy, which helps your body's own immune system fight cancer.
To make sure the results are fair and reliable, this study is a 'double-blind' trial. This means that neither the patients nor their doctors will know whether they are receiving the pembrolizumab or a 'placebo' (an inactive substance that looks just like the real drug). Everyone will still receive the standard chemotherapy (cisplatin) and radiation therapy. This setup helps researchers accurately compare if the new drug makes a real difference in how well patients do.
The main things the researchers are looking at are whether patients live longer without their cancer growing (this is called 'progression-free survival') and how long patients live overall ('overall survival'). They will also look at how many patients have their cancer shrink or disappear completely. By carefully comparing the two groups, the study hopes to discover if adding pembrolizumab can offer a more effective treatment option for women with this type of cervical cancer.
Key takeaways
- Tests a new combination treatment for cervical cancer.
- Combines standard care with an immunotherapy called pembrolizumab.
- Aims to improve how long patients live without cancer progression.
- It's a 'double-blind' study to ensure fair results.
- All participants receive standard chemotherapy and radiation.
- For women aged 18 and over with locally advanced cervical cancer.
Who may be eligible?
To be considered for this study, you would need to be a woman aged 18 or older. The medical team would check if you have locally advanced cervical cancer, which means the cancer has grown into nearby areas but hasn't spread to distant parts of your body.
There will be other specific health requirements and medical tests to make sure the study treatment is safe and suitable for you. This might include checking your general health and whether you have other medical conditions that could affect your ability to take part.
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 locally advanced cervical cancer?
- Are you generally well enough to undergo cancer treatments?
- Are you able to attend regular clinic appointments and follow-ups?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to one of two groups: one receiving the standard chemotherapy and radiation plus pembrolizumab, and the other receiving the standard treatment plus a placebo. You wouldn't know which group you're in, and neither would your doctors.
Taking part would involve regular visits to the clinic for your treatments, which will include chemotherapy (cisplatin) and radiation therapy, along with infusions of either pembrolizumab or the placebo. You would have frequent check-ups and tests, such as scans (like CT or MRI) to monitor how your cancer is responding to the treatment and to keep an eye on your general health.
After your main course of treatment, there would be follow-up visits and assessments over a longer period, possibly several years, to track your progress and overall health. The total duration of your participation would depend on the study's plan for monitoring and how you respond to the treatment.
Potential risks and benefits
Locations (12)
- —UnverifiedGermany
- —UnverifiedNorway
- —UnverifiedIreland
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedCzechia
- —UnverifiedItaly
- —UnverifiedSweden
- —UnverifiedHungary
- —UnverifiedAustria
- —UnverifiedGreece
Common questions
What is 'locally advanced' cervical cancer?
It means the cancer has grown into nearby tissues around the cervix but hasn't spread to distant parts of your body.
What is pembrolizumab (Keytruda)?
It's a type of immunotherapy that helps your body's own immune system find and fight cancer cells.
What does 'double-blind' mean in a study?
It means neither you nor your doctors will know if you're receiving the new drug or a placebo, to help keep the study fair.
Will I still get standard treatment?
Yes, everyone in the study will receive the standard chemotherapy (cisplatin) and radiation therapy.
What are the main goals of this study?
The study aims to see if adding pembrolizumab helps patients live longer without their cancer growing, and improves overall survival.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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