A trial of pembrolizumab for cancer of the stomach and cancer where the food pipe joins the stomach

Cancer type:

Oesophageal cancer
Secondary cancers

Status:

Open

Phase:

Phase 3

This trial is for people whose cancer has grown into the surrounding tissue (locally advanced) or to another part of the body (advanced).

Cancer where the food pipe (oesophagus) joins the stomach is called gastro oesophageal junction cancer. 

More about this trial

Doctors treat stomach cancer and gastro oesophageal junction cancer in the same way. The standard treatment Open a glossary item for advanced stomach cancer and gastro oesophageal cancer is chemotherapy. You might have trastuzumab with chemotherapy if your cancer has a large amount of the HER2 Open a glossary item protein. 
 
Pembrolizumab is an immunotherapy. It works by stimulating the body’s immune system Open a glossary item to fight cancer cells. 
 
We know from previous clinical trials that pembrolizumab can help people with advanced stomach cancer and gastro oesophageal junction cancer. 
 
In this trial researchers will compare:
  • chemotherapy, trastuzumab and pembrolizumab
  • chemotherapy, trastuzumab and a dummy drug (placebo Open a glossary item)
The aims of this trial are to find:
  • out if adding pembrolizumab to chemotherapy and trastuzumab is better 
  • what the side effects are and how acceptable they are
  • what the quality of life Open a glossary item is

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 cancer of the stomach or cancer of the area where the food pipe joins the stomach (gastro oesophageal junction) that hasn’t been treated 
  • have cancer that has grown into the surrounding tissue (locally advanced) and cannot be removed by surgery or your cancer has spread to another part of the body (advanced cancer)
  • have cancer that has a large amount of the HER2 protein (HER2 positive)
  • have an area of cancer that can be measured on a scan
  • are able to do everything apart from heavy physical work (performance status 0 or 1)
  • have satisfactory blood test results
  • have satisfactory heart test results
  • are willing to use reliable contraception during treatment and for 7 months after if you or your partner could become pregnant
  • are at least 18 years old
 
Who can’t take part
 
Cancer related
You cannot join this trial if any of these apply. You:
  • have had treatment for your locally advanced or advanced cancer, if you had chemotherapy before or after surgery to remove the cancer from your stomach or gastro oesophageal junction it must have been finished more than 6 months ago and your cancer hasn’t grown any further 
  • have cancer that has spread to the brain or spinal cord unless it has been treated, a scan shows it is stable and you haven’t had steroids for at least 2 weeks before starting the trial treatment
  • have had radiotherapy within 2 weeks of being put into a treatment group for this trial, for radiotherapy to relieve symptoms (palliative), apart from the brain and spinal cord, it is within 1 week 
  • have another cancer that in the past 5 years started to get worse or needed treatment apart from successfully treated non melanoma skin cancer Open a glossary item or in situ carcinoma Open a glossary item of the cervix 
  • have ongoing moderate to severe nerve damage from previous treatment
Medical condition
You can’t take part if any of the following apply. You:
  • have an active autoimmune disease Open a glossary item that has needed treatment that reaches the whole body (systemic treatment) in the past 2 years, apart from treatment, such as thyroxine and insulin, that is used as a replacement 
  • have had major surgery in the past month or might need surgery during the trial
  • haven’t recovered from any past surgery
  • have been diagnosed with a disease that affects your immune system Open a glossary item 
  • are taking steroids more than 10mg a day apart from creams and inhalers
  • are taking any other medication that affects your immune system within a week of starting the trial treatment
  • have a lung inflammation (pneumonitis) or have had steriods for it in the past
  • have tuberculosis (TB)
  • have an active infection that needs treatment
  • have diarrhoea that is not well controlled
  • have fluid on the lung (pleural effusion), on the abdomen (ascites) or around the heart (pericardial) that needs treatment by draining or with fluid medication (diuretics)  
  • have had a heart attack in the past 6 months or any other serious heart problem such as congestive heart failure or coronary artery disease
  • are taking medication to correct your heart beat, apart from beta blockers and digoxin 
  • have unstable angina or have been diagnosed with angina in the past 3 months
  • have hepatitis B or hepatitis C
  • have HIV
  • have had a tissue transplant 
  • have already had a drug that works in a similar way to pembrolizumab
  • are taking part or have taken part in another clinical trial using an experimental drug or device within 4 weeks of starting treatment in this trial
  • have any other medical or mental health condition that your doctor or the trial team think could affect you taking part
Other
You can’t take part if any of the following apply. You:
  • are very sensitive or allergic to any of the drugs used in this trial or any of their ingredients
  • have had a live vaccine in the month before starting treatment in this trial
  • are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The trial team needs about 732 people worldwide to join the trial. 
 
It is a randomised trial. Everyone is put into 1 of 2 treatment groups. Neither you or your doctor can choose which group you are in. 
 
You have an equal chance of being put into either treatment group.

Neither you or your doctor will know if you are in the group having pembrolizumab or the dummy drug. This is a double blind trial.
 
There are 2 different chemotherapy treatments you might have:
Your doctor will talk to you about which would be the best chemotherapy for you. 
 
You have your treatment every 3 weeks. Each 3 week period is called a cycle of treatment.
 
Pembrolizumab and dummy drug
You have pembrolizumab as a drip into a vein. You have pembrolizumab on the 1st day of each cycle of treatment. 
 
You can have up to 35 cycles of treatment (about 2 years) as long as it is helping and the side effects aren’t too bad. 
 
If you are in the pembrolizumab group, you might be able to have another year of pembrolizumab if your cancer gets worse after:
  • completing 2 years of treatment
  • you stopped treatment because there was no sign of your cancer
You have the dummy drug the same way as pembrolizumab. 
 
Trastuzumab
You have trastuzumab as a drip into a vein. 
 
You have the first treatment over 90 minutes and the team caring for you will monitor you for side effects. Depending on the side effects the next treatments can be between 30 minutes and 90 minutes.  
 
You have trastuzumab once on the 1st day of every cycle of treatment. You continue to have trastuzumab as long as it is helping and the side effects aren’t too bad. 
 
Cisplatin and 5FU
You have cisplatin and 5FU as a drip into a vein. 
 
You have cisplatin over 1 hour or 2 hours. You have cisplatin on the 1st day of each cycle of treatment. You have up to 6 cycles of treatment. You might have more if your doctor thinks it will help. 
 
You have 5FU continuously over 5 days starting on the 1st day of each cycle of treatment. You have it through a pump. You will need to stay in hospital when having 5FU if you don’t have a central line
 
If you have a central line you can have it through a pump which you can take home. You will have a small bag to carry the pump in. When the 5FU is finished you go back to the hospital to have the pump disconnected. 
 
You might continue to have 5FU if your doctor thinks it is helping and is safe. 
 
You have up to 6 cycles of cisplatin. You might have more if your doctor thinks it will help.  
 
Oxaliplatin and capecitabine
You have oxaliplatin as a drip into a vein. You have oxaliplatin over 1 hour or 2 hours. You have it on the 1st day of each 3 week cycle of treatment. 
 
Capecitabine is a tablet. Your doctor will tell you how many tablets to take. You take them twice a day for 2 weeks starting on the 1st day of each cycle of treatment. 
 
You might have 6 to 8 cycles of oxaliplatin and capecitabine treatment. This depends on the standard of care at the hospital you are having treatment. 
Quality of life 
You fill in a few questionnaires:
  • at the start of treatment
  • then every 3 weeks up to 15 weeks (5 treatment cycles)
  • then every 6 weeks till you finish treatment 
  • then a month after you finish treatment
The questions ask about:
  • your general health and wellbeing
  • any side effects you might have
  • what you can do in your daily life
These questionnaires are quality of life questionnaires
 
Tissue and blood samples
The trial team will ask for a piece of tissue (biopsy Open a glossary item) of your cancer. This can be from when you had a piece taken to diagnose your cancer or from any previous surgery to remove your cancer. If this isn’t available, you must agree to have a fresh piece of tissue taken. 
 
The team will take extra blood samples. They will use these samples to look for substances in the blood (biomarkers Open a glossary item) that could tell them how well pembrolizumab is working. They will also use some of these samples to find out what happens to pembrolizumab and trastuzumab in the body. 

Hospital visits

You see the doctor to have some tests before taking part. These tests include:
  • a physical examination
  • blood tests
  • urine tests
  • heart trace (ECG Open a glossary item)
  • heart scan (ECHO Open a glossary item or MUGA Open a glossary item)
  • CT scan or MRI scan
  • hearing test (only if you are having cisplatin)
You see the doctor every 3 weeks during treatment for:
  • a physical examination
  • blood tests
You have a CT scan or MRI scan every 6 weeks. You have a heart scan:
  • at 9 weeks 
  • at 15 weeks 
  • then every 12 weeks 
You see the doctor when you complete your treatment for:
  • a physical examination
  • blood tests
  • CT scan or MRI scan
You see the doctor again a month later for blood tests and to see how you are. You then see the doctor every 6 weeks for a CT scan or MRI scan. 
 
During treatment if your cancer gets worse treatment will stop. You see the doctor and have a CT scan. You see the doctor, or a member of the trial team will phone you every 3 months or more often to see how you are. 

Side effects

Your doctor and nurse will monitor you closely for any side effects. Let your doctor or nurse know as soon as possible if:
  • you have severe side effects 
  • your side effects aren’t getting any better
  • your side effects are getting worse
  • you notice anything unusual or anything that has changed
Because of the way pembrolizumab works some side effects can become very serious, life-threatening and may cause death. 
 
The most common side effects of pembrolizumab include:
  • itchy skin, rash
  • diarrhoea
  • cough
  • joint pain
  • high temperature (fever)
  • back pain
  • stomach pain
  • loss of skin colour
  • your thyroid Open a glossary item not making enough hormones causing tiredness, weight gain, feeling cold and hard infrequent poo
  • less salt in the blood causing tiredness, confusion, headaches, muscle cramps and, or feeling sick 
We have more information about pembrolizumab and its side effects
 
We have information about the side effects of:
Your doctor or a member of the trial team will talk to you about the possible side effects of all the treatments used in this trial before you agree to take part.

Location

Derby
Dundee
Hull
London
Manchester
Middlesex
Walsall

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Kai-Keen Shiu

Supported by

Merck, Sharp and Dohme

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15841

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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