A study of pembrolizumab for cancer of the foodpipe (oesophagus) that has spread (KEYNOTE 180)

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

You may be able to join this study if all of the following apply. 

• You have a type of cancer called adenocarcinoma or squamous cell carcinoma of the stomach or adenocarcinoma of the place where the stomach and foodpipe join (the gastro oesophageal junction)
• Your cancer has spread to another part of the body
• For people with gastro oesophageal cancer whose cancer is HER2 positive , your cancer got worse while having a drug called trastuzumab.
• You have had 2 treatments that reach the whole body (systemic treatment) and your cancer has continued to get worse
• Your cancer can be measured on a scan
• You are willing to have a sample (biopsy ) of your cancer taken for testing. If it isn’t possible to take a biopsy, the study team might be able to use a sample taken previously.
• You have satisfactory blood test results
• You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1) 
• You are willing to use reliable contraception during treatment and for up to 4 months afterwards if there is any chance that you or your partner could become pregnant
• You are at least 18 years old

You cannot join this study if any of these apply. You

• Have cancer spread to your brain that is causing symptoms
• Have inflammation of the covering of the brain (carcinomatous meningitis) caused by your cancer
• Have had a monoclonal antibody, chemotherapy, biological therapy or radiotherapy in the 2 weeks before starting study treatment
• Have had previous treatment with any anti-PD1, anti-PDL1, anti-PD2 drugs such as nivolumab or any similar drugs 
• Have had treatment with an experimental drug in the last 4 weeks`
• Have an active autoimmune disease and have had drugs that suppress your immune system in the last 2 years
• Have a lung condition called pneumonitis and you need steroids or  you have interstitial lung disease
• Have problems with your immune system or have taken drugs that suppress your immune system in the last 7 days
• Have had any other cancer in the last 5 years apart from carcinoma in situ of the cervix, non melanoma skin cancer or very early breast cancer that was successfully treated
• Have not recovered from any major surgery
• Have side effects for any previous cancer treatment apart from hair loss and mild numbness and tingling in your fingers and toes (peripheral neuropathy)
• Have had a live vaccine in the last 30 days
• Are known to have HIV 
• Have an active hepatitis B or hepatitis C infection
• Have an infection that needs treatment
• Have any other serious medical condition or mental health problem that the study team think could affect you taking part
• Are pregnant or breastfeeding