A trial of nivolumab and ipilimumab for stomach cancer and gastro oesophageal junction cancer (CA209-649)

• You have stomach (gastric) cancer or cancer where the food pipe (oesophagus) joins the stomach (gastro oesophageal junction cancer)
• Your cancer can’t be removed by surgery or has spread into the surrounding tissue (advanced) or has spread to another part of the body (metastatic)
• You have at least 1 area of cancer that can be measured on a CT scan  or MRI scan
• A sample of cancer tissue (biopsy ) is available for the trial team or you must be willing to have a biopsy done
• You have satisfactory blood test results
• You are able to do all your daily activities apart from heavy physical work (performance status 0 or 1)
• You must be willing to use reliable contraception during treatment and for up to 7 months afterwards if you or your partner could become pregnant
• You are at least 18 years old

• Your cancer has receptors for HER2  (is HER2 positive)
• You have had chemotherapy, radiotherapy or chemoradiation  in the past 6 months before being put (randomised ) into a treatment group for this trial, if you had radiotherapy to relieve symptoms (palliative radiotherapy) it must be finished at least 2 weeks before you are randomised
• Your cancer has spread to the brain or spinal cord unless it has been treated and there have been no symptoms for 2 weeks before being randomised and you must not be taking steroids or be on a stable dose or a decreasing dose of 10mg or less for 2 weeks before being randomised
• You have had treatment that reached your whole body (systemic treatment) such as chemotherapy for cancer that has spread into the surrounding tissue (advanced) or to another part of the body (metastatic)
• You still have side effects of previous cancer treatment apart from mild hearing loss, hair loss or tiredness (fatigue)
• You have fluid collected in the abdomen (ascites) that can’t be controlled

• You have had another cancer in the past 3 years apart from an early cancer  that has been successfully treated such as non melanoma skin cancer, superficial bladder cancer or carcinoma in situ of the breast, prostate or cervix
• You have an autoimmune disease  apart from type 1 diabetes, an underactive thyroid gland that only needs hormone replacement, skin conditions such as vitiligo and psoriasis or hair loss (alopecia) 
• You are taking steroids or other medication that affects the immune system within 2 weeks of starting treatment in this trial apart from inhalers, steroid creams and 10 mg or more dose of steroids to replace adrenal gland hormones
• You have had treatment that works in a similar way to nivolumab and ipilimumab
• You have nerve damage (neuropathy) that is moderate to severe
• You have another medical or mental health condition that the trial team thinks could affect you taking part in the trial
• You have HIV, hepatitis B or hepatitis C

Other

• You are allergic or very sensitive to drugs, or any of their ingredients, used in this trial
• You are pregnant or breastfeeding