A trial of pembrolizumab for cancer of the stomach and cancer where the food pipe joins the stomach
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
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



- chemotherapy, trastuzumab and pembrolizumab
- chemotherapy, trastuzumab and a dummy drug (
placebo )
- 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 is
Who can enter
- 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
- 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 or
in situ carcinoma of the cervix
- have ongoing moderate to severe nerve damage from previous treatment
- have an active
autoimmune disease 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 - 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
- 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
- chemotherapy, trastuzumab and pembrolizumab
- chemotherapy, trastuzumab and a dummy drug (placebo)
- completing 2 years of treatment
- you stopped treatment because there was no sign of your cancer
- 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
- your general health and wellbeing
- any side effects you might have
- what you can do in your daily life


Hospital visits
- a physical examination
- blood tests
- urine tests
- heart trace (
ECG )
- heart scan (
ECHO or
MUGA )
- CT scan or MRI scan
- hearing test (only if you are having cisplatin)
- a physical examination
- blood tests
- at 9 weeks
- at 15 weeks
- then every 12 weeks
- a physical examination
- blood tests
- CT scan or MRI scan
Side effects
- 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
- itchy skin, rash
- diarrhoea
- cough
- joint pain
- high temperature (fever)
- back pain
- stomach pain
- loss of skin colour
- your
thyroid 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
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.
Chief Investigator
Dr Kai-Keen Shiu
Supported by
Merck, Sharp and Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040