A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer (KEYNOTE-866)
This important study, known as KEYNOTE-866, is looking at a new way to treat muscle-invasive bladder cancer. This is a type of bladder cancer that has grown into the muscle of the bladder wall. The study is for people who can have cisplatin, a common chemotherapy drug. Researchers want to find out if giving a drug called pembrolizumab (also known as Keytruda) along with standard chemotherapy, both before and after surgery, can improve how long people stay free of cancer. Some participants will receive Keytruda and chemotherapy, while others will receive a dummy drug (placebo) and chemotherapy. This helps researchers compare the treatments fairly. The study also looks at side effects, quality of life, and how long people live.
At a glance
What is this study about?
This study is a Phase 3 clinical trial, which means it's a large, in-depth study designed to confirm if a new treatment is effective and safe. The main goal is to see if adding a medication called pembrolizumab (brand name Keytruda) to the usual chemotherapy treatment can help people with muscle-invasive bladder cancer. This type of cancer is serious because it has grown into the bladder wall. Currently, the standard approach often involves chemotherapy followed by surgery to remove the bladder.
The researchers are investigating if giving pembrolizumab alongside chemotherapy before surgery, and then continuing pembrolizumab after surgery, can reduce the chance of the cancer coming back or getting worse. Pembrolizumab works by helping your own immune system fight cancer cells. By comparing it to chemotherapy with a dummy drug (placebo), the study aims to clearly show if this new combination is better at keeping people well. It's about finding improved ways to tackle this type of bladder cancer, hoping to give patients a better outlook.
Ultimately, the study wants to understand if this new treatment approach leads to a longer period of time without the cancer returning or progressing. It also looks at how the treatment impacts your overall health, if it reduces the amount of cancer found after surgery, and importantly, how it affects your quality of life. This includes measuring pain, how well you can do daily activities, and your general wellbeing, as well as tracking any side effects.
Key takeaways
- This study evaluates an immunotherapy drug (Keytruda) with standard chemotherapy for bladder cancer.
- It aims to see if this combination improves how long people stay cancer-free after treatment.
- Participation involves receiving either the new drug or a dummy drug alongside chemotherapy.
- The study assesses cancer control, side effects, and quality of life.
- It's a Phase 3 study, meaning it's a large trial to confirm treatment effectiveness.
Who may be eligible?
To join this study, you need to have a specific type of bladder cancer that has grown into the muscle layer of your bladder. It's important that your doctors believe you are able to have a chemotherapy drug called cisplatin, which is a key part of the standard treatment for this cancer.
You must be at least 18 years old to take part. The study is open to both men and women. The medical team will carefully review your health records to make sure you fit all the necessary requirements and that taking part would be safe 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.
- Do I have bladder cancer that has grown into the muscle?
- Am I considered eligible for treatment with cisplatin chemotherapy?
- Am I 18 years old or older?
- Have I discussed my overall health with my doctor to confirm fitness for a trial?
What does participation involve?
If you decide to join this study, you will be assigned by chance (like a lottery) to one of two groups. One group will receive chemotherapy along with the study drug, pembrolizumab. The other group will receive chemotherapy along with a dummy drug (placebo). Neither you nor your study doctor will know which group you are in.
You will have several appointments at the clinic for treatments, which involve infusions (medicine given through a drip). These visits will include regular check-ups, blood tests, and scans to monitor your health and how the treatment is working. You'll also be asked to complete questionnaires about your quality of life and how you're feeling. This treatment phase will be both before and after surgery. After the treatment period, you will have regular follow-up visits to track your health and for checks on your cancer. The total time you'll be involved in the study, including follow-up, could be for several years.
Potential risks and benefits
Locations (10)
- —UnverifiedHungary
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedSweden
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedDenmark
- —UnverifiedIreland
- —UnverifiedItaly
- —UnverifiedPoland
Common questions
What is muscle-invasive bladder cancer?
It's a type of bladder cancer that has grown from the inner lining into the muscle wall of the bladder.
What is pembrolizumab (Keytruda)?
It's a drug that helps your body's immune system fight cancer. It's also called immunotherapy.
Why is a 'dummy drug' (placebo) used?
Using a dummy drug helps researchers fairly compare the new treatment against the standard approach to see if it truly makes a difference.
What will happen to my usual cancer treatment?
This study combines the new drug with your usual chemotherapy, which is a standard part of treatment for your type of cancer.
Will I know if I'm getting the new drug or the dummy drug?
No, neither you nor your study doctor will know which treatment you are receiving until the study is over, or if there's a medical need to find out.
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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