A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)
This important study is testing a new way to treat stomach cancer and cancer in the area where your food pipe meets your stomach. It's called KEYNOTE-585. Doctors are comparing a new drug, pembrolizumab (also known as Keytruda), when given with standard chemotherapy, against chemotherapy alone. The treatment is given both before and after surgery. The main goals are to see if adding pembrolizumab helps patients live longer without the cancer returning, and to understand how many people respond well to the treatment. The study also carefully tracks any side effects to make sure the treatment is safe. By doing this research, doctors hope to find better ways to treat these types of cancers in the future.
At a glance
What is this study about?
This study, called KEYNOTE-585, is looking for a better way to treat certain stomach cancers. Specifically, it's focused on cancers of the stomach and where the food pipe connects to the stomach (which doctors call the gastroesophageal junction, or GEJ). These are important areas of the body, and this type of cancer can be challenging to treat, so new options are always being explored.
The trial wants to find out if adding a drug called pembrolizumab (you might hear it called Keytruda) to standard chemotherapy is more effective than chemotherapy on its own. Pembrolizumab is a type of medicine that helps your body's own immune system fight cancer. The treatment plan involves giving medicines both before surgery, to try and shrink the tumour, and after surgery, to help prevent the cancer from coming back. This is known as 'neoadjuvant/adjuvant' treatment.
The main things the researchers are looking at include how long people live without the cancer returning, how many people's tumours completely disappear after treatment, and overall how long people live after their diagnosis. They are also carefully watching for any side effects or problems that might come up, to make sure the treatment is safe. By comparing these different treatment approaches, the study aims to improve care for people with these specific cancers.
Key takeaways
- The study is investigating a new treatment for stomach and GEJ cancer.
- It combines a drug called pembrolizumab with standard chemotherapy.
- Treatment is given both before and after surgery.
- Researchers are looking at improving survival and reducing cancer recurrence.
- Participants will receive either pembrolizumab or a placebo alongside chemotherapy.
Who may be eligible?
To be able to join this study, people generally need to be at least 18 years old. Both men and women can take part. There will be other medical checks to make sure the study is right for you, for example, your general health and the type of stomach or gastroesesophageal junction cancer you have.
The doctors running the study will carefully review your medical history and test results to see if you fit all the requirements. They need to make sure the study is a good match for your specific situation and that it would be safe for you to take part.
- Are you 18 years old or older?
- Do you have stomach cancer or cancer where your food pipe joins your stomach?
- Are you able to undergo chemotherapy and potentially surgery?
- Are you in generally good health, apart from your cancer diagnosis?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you would receive treatments that include chemotherapy combinations (like OXALIPLATIN, CAPECITABINE, FLUOROURACIL, CISPLATIN, CALCIUM FOLINATE, DOCETAXEL) and either pembrolizumab or a 'placebo' (a dummy drug). You wouldn't know whether you were getting pembrolizumab or the placebo, and neither would your doctors; this is called 'double-blind'. You would have regular visits to the hospital for your treatment sessions and tests. These tests would include scans (like CT scans) to check how the cancer is responding, and blood tests to monitor your health and any side effects. The study will continue for a period, including follow-up checks after your main treatment has finished, to see how you are doing in the long term. The exact number of visits and their frequency would be explained by the study team.
Potential risks and benefits
Locations (8)
- —Poland
- —Belgium
- —Italy
- —France
- —Germany
- —Latvia
- —Estonia
- —Lithuania
Common questions
What is pembrolizumab and how does it work?
Pembrolizumab is a drug that helps your body's immune system fight cancer cells. It's a type of immunotherapy.
What is a placebo?
A placebo is an inactive substance, like a sugar pill or a saline solution, used in trials to see if the new treatment works better than no specific treatment for comparison.
What does 'neoadjuvant/adjuvant treatment' mean?
Neoadjuvant treatment is given before surgery to shrink the tumour, and adjuvant treatment is given after surgery to kill any remaining cancer cells and help stop the cancer from coming back.
How long would I be in the study?
The study involves treatment periods and then follow-up checks. The exact duration would be explained by the study doctor, but it's likely to be over several months to a few years to properly track outcomes.
Will I still get standard treatment if I join?
Yes, all participants will receive standard chemotherapy as part of their treatment, whether they are in the group getting pembrolizumab or the group getting the placebo.
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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