
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is for people with stomach cancer or cancer of the area where the food pipe joins the stomach (gastro oesophageal junction).
Everyone taking part is going to have treatment for their cancer for the first time.
You usually have chemotherapy for stomach and gastro oesophageal junction cancer. You then have surgery to remove all or part of your stomach.
Depending on the results of surgery, you might need more chemotherapy. This lowers the chance of the cancer coming back. You often have a combination of the following chemotherapy drugs:
In this trial, doctors are looking at the drug pembrolizumab (Keytruda). Pembrolizumab is a type of immunotherapy. It stimulates the body’s immune system to fight cancer cells.
Everyone taking part in this trial has 1 of the following:
The main aim of this trial is to find out whether pembrolizumab helps people with stomach and gastro oesophageal junction cancer who are going to have treatment for the 1st time.
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply:
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You have had:
Medical conditions
You:
Other
You:
This is an international phase 3 trial. Researchers hope that around 800 people will take part.
This is a randomised trial. Everyone taking part is put into 1 of 2 groups by computer.
People in group 1 have the following:
People in group 2 have the following:
Neither you nor your doctor are able to decide which group you are in. And neither you nor your doctor will know which group you are in. This is a double bind trial.
Group 1
First, you have 3 treatment cycles of chemotherapy and pembrolizumab.
Each treatment cycle takes 21 days (3 weeks). You have each cycle in the following way:
About 6 weeks after you finish your 3 cycles of chemotherapy and pembrolizumab, you have surgery. You have surgery in the same way as if you weren’t taking part in this trial. Your doctor can tell you more about this and what to expect.
Then between 4 and 10 weeks after your surgery, you have:
Your doctor might also suggest that you have a different combination of chemotherapy drugs. You may have a chemotherapy regimen called FLOT instead of cisplatin and capecitabine or fluorouracil.
If you have the FLOT regimen, you have:
Your doctor will tell you which chemotherapy treatment you have before you join the trial.
Group 2
You have the same treatment as group 1, but you have a dummy drug instead of pembrolizumab. You have the dummy drug as a drip into a vein. It takes about 30 minutes each time you have it.
Blood tests
You have extra blood tests as part of this trial. Researchers want to:
You have the extra blood tests before the start of treatment and at set times during the trial.
The research team will ask to keep your blood samples and use them in future research studies. They keep the samples for up to 15 years.
Tissue sample
The trial team ask to use a tissue sample of your cancer that you had taken when you were diagnosed (archival tissue sample). You need to have a biopsy if there isn’t a suitable sample available.
The team also ask for a sample of tissue to be taken during surgery. They want to find out why cancer treatments work for some people but not for others.
You see a doctor and have some tests before taking part. These tests might include:
During treatment, you see the trial doctor every week. You have blood tests and a physical examination each time you see them.
You have a CT scan or MRI scan before and after surgery. You then have a CT scan or MRI scan:
When you finish treatment, you see the trial doctor after a month. You have blood tests and a physical examination. You then see or speak with the trial team every 12 weeks (3 months).
The trial team monitor you during the time you have treatment and afterwards. You have a phone number to call them if you are worried about anything.
The team will tell you about all the possible side effects before you start the trial. The most common side effects of pembrolizumab are:
We have more information about the possible side effects of pembrolizumab.
We also have information about the side effects:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Ian Chau
Merck, Sharp & Dohme
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”