A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)
This study is investigating a new treatment approach for advanced stomach cancer or cancer where the food pipe joins the stomach (called HER2 positive adenocarcinoma). Researchers want to see if adding a drug called pembrolizumab (also known as KEYTRUDA) to the usual chemotherapy and trastuzumab treatment can improve how long patients live, and how long they live before their cancer gets worse. This is a large study where some patients will receive pembrolizumab, and others will receive a dummy drug (placebo) alongside their standard treatment. Doctors and patients won't know who is getting which. The aim is to find out if this new combination is more effective than current treatments.
At a glance
What is this study about?
This clinical trial, called KEYNOTE 811, is designed to find out if a new combination of medicines can help people with advanced stomach cancer or cancer of the area where the food pipe meets the stomach. This specific type of cancer is called HER2-positive adenocarcinoma. Being 'advanced' means the cancer has spread beyond its original location.
The study is comparing two treatment approaches. Everyone in the study will receive standard chemotherapy (medicines like fluorouracil, cisplatin, capecitabine, or oxaliplatin) along with another targeted drug called trastuzumab. Some patients will also receive an additional drug called pembrolizumab, while others will receive a 'placebo.' A placebo looks just like pembrolizumab but doesn't contain any active medicine. This is done so researchers can accurately compare the effects of pembrolizumab.
The main goal of the study is to see if adding pembrolizumab can help patients live longer without their cancer growing (this is called 'progression-free survival') and also if it helps them live longer overall ('overall survival'). Researchers will also look at how many patients respond to the treatment, how long that response lasts, and what side effects people experience.
Key takeaways
- This study is testing a new combination treatment for advanced stomach or food pipe cancer.
- It aims to see if adding pembrolizumab to standard therapy improves patient outcomes.
- All participants will receive standard chemotherapy and trastuzumab.
- Some will also receive pembrolizumab, and others a placebo.
- The study primarily looks at how long patients live without their cancer growing, and overall survival.
Who may be eligible?
To be able to take part in this study, you would generally need to be at least 18 years old. There is no upper age limit mentioned.
Your doctor would need to confirm that you have advanced stomach cancer or cancer where the food pipe joins the stomach, and that it is of the 'HER2 positive' type.
There will be other detailed medical checks to make sure the study treatment is safe for you and that you meet all the necessary health requirements.
- Are you 18 years old or older?
- Have you been diagnosed with advanced stomach or food pipe cancer?
- Has your doctor confirmed your cancer is 'HER2 positive'?
- Are you generally able to receive chemotherapy treatments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you would receive infusions (drips) of the study medicines, which include chemotherapy, trastuzumab, and either pembrolizumab or a placebo. These treatments would be given over a period of time, likely in cycles, with regular visits to the hospital or clinic.
During these visits, you would have various tests and scans to monitor your health and how the treatment is working. This could include blood tests, physical exams, and imaging scans (like CT scans) to check the size of your cancer. Doctors would also carefully record any side effects you experience.
The total duration of your participation would depend on how your cancer responds to the treatment and your general health, but it often involves regular appointments for several months or even longer, followed by a period of follow-up to check on your long-term health.
Potential risks and benefits
Locations (6)
- —Ireland
- —France
- —Spain
- —Germany
- —Poland
- —Italy
Common questions
What does 'HER2 positive' mean?
HER2 positive means your cancer cells have a lot of a specific protein on their surface. This protein can make the cancer grow faster, and some drugs are designed to target it.
What is 'chemotherapy'?
Chemotherapy uses strong medicines to kill cancer cells or slow their growth. It can affect healthy cells too, which causes side effects.
What is 'pembrolizumab'?
Pembrolizumab is a type of immunotherapy. It works by helping your body's own immune system find and fight cancer cells.
What is a 'placebo'?
A placebo is a dummy treatment. It looks exactly like the real drug but contains no active medicine. This helps researchers fairly compare the new drug's effects.
Will I know if I'm getting the drug or the placebo?
No, in this type of 'double-blind' study, neither you nor your doctors will know whether you are receiving pembrolizumab or the placebo. This helps prevent bias in the study results.
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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