A trial of pembrolizumab and chemotherapy for stomach and gastro oesophageal junction cancer (KEYNOTE-585)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Oesophageal cancer

Stomach cancer

Status:

Closed

Phase:

Phase 3

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.

More about this trial

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:

chemotherapy and pembrolizumab, followed by surgery and more chemotherapy and pembrolizumab
chemotherapy and dummy drug (placebo), followed by surgery and more chemotherapy and dummy drug

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.

Who can enter

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:

you have stomach or gastro oesophageal junction cancer that has grown at least into the outer lining of the stomach (T3 stage or higher)
you are going to have treatment for stomach or gastro oesophageal junction cancer for the 1st time
your doctor thinks you can have chemotherapy and surgery
you have had a CT scan or MRI scan to find how big the cancer is and whether it has spread (stage)
you are willing to have a sample of tissue (biopsy) taken from your cancer, if there isn’t a suitable sample available that was taken at the time of your diagnosis
you are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
you have satisfactory blood tests results
you are at least 18 years old
you are willing to use reliable contraception during treatment and for up to 6 months afterwards if there is any possibility you or your partner could become pregnant

Who can’t take part
You cannot join this trial if any of these apply.

Cancer related
You have had:

pembrolizumab or any other similar drug
treatment for stomach or gastro oesophageal junction cancer that reached your whole body (systemic)
radiotherapy in the past 2 weeks and you still have side effects from it
another cancer in the past 5 years apart from successfully treated non melanoma skin cancer or early cancer (carcinoma in situ) of the cervix and breast

Medical conditions
You:

are allergic or sensitive to any of the drugs used in this trial or anything they contain
have had an experimental treatment in the past month
have an autoimmune disease that has needed treatment in the past 2 years, apart from taking medication to replace something the body makes such as thyroxine and insulin
have taken drugs that damp down your immune system (steroids) in the past 2 weeks, unless it was a very small dose
have an infection and you need treatment such as antibiotics that reach your whole body (systemic treatment)
have had, or currently have, lung problems such as pneumonitis that needed treatment with steroids
have HIV
have hepatitis B or hepatitis C
have tuberculosis (TB)
have any other medical or mental health condition that the trial team think could affect you taking part
take an amount of drugs or drink an amount of alcohol that is a concern for the trial team

Other
You:

are pregnant or breastfeeding
have had a live vaccine in the last month

Trial design

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:

chemotherapy and pembrolizumab
then surgery
then more chemotherapy and pembrolizumab
then pembrolizumab alone

People in group 2 have the following:

chemotherapy and dummy drug
then surgery
then more chemotherapy and dummy drug
then dummy drug alone

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.

KEYNOTE-585

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:

you have pembrolizumab as a drip into a vein on day 1
you have cisplatin as a drip into a vein on day 1
you have capecitabine as tablets that you take twice a day for 2 weeks or you have fluorouracil as a drip into a vein on day 1 and 5 (your doctor can tell you which treatment you have)

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:

3 treatment cycles with cisplatin and either capecitabine or fluorouracil, and pembrolizumab
then 11 treatment cycles with pembrolizumab alone

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:

docetaxel (Taxotere)
oxaliplatin (Eloxatin)
calcium folinate (Leucovorin)
fluorouracil (5FU)

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:

look at the levels of certain proteins (biomarkers) that can tell how well the treatment is working
find out what happens to pembrolizumab in your body (pharmacokinetics)

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.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

physical examination
blood tests
urine test
heart trace (ECG)
CT scan or MRI scan

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:

every 3 months for 2 years
then every 6 months for a year

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).