A trial looking at MEDI4736 and tremelimumab for people with head and neck cancer (KESTREL)

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.

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

• You have squamous cell carcinoma of the head and neck that has come back or spread to another part of your body
• You are not able to have any treatment to cure your cancer such as surgery or radiotherapy
• You are willing to have a sample of your cancer taken (a biopsy ) if there is no suitable sample available that is less than 3 years old
• You have satisfactory blood tests results
• You have a satisfactory heart rate
• You have at least 1 area of cancer that hasn’t been treated with radiotherapy , can be seen on a scan and measures at least 10 mm
• You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
• You are at least 18 years old
• You are willing to use reliable contraception during treatment and for 3 months after the final dose of MEDI4736 or for 6 months after the last dose of MEDI4736 and tremelimumab if there is any possibility you or your partner could become pregnant. If you have standard treatment, the trial team will advise you how long you should use reliable contraception for

You cannot join this trial if any of these apply

• Your cancer has spread to your brain, the tissues surrounding your brain or your spinal cord
• You have had another cancer in the last 5 years apart from cancers that have not spread (carcinoma in situ ) and that have been successfully treated
• You have had treatment that reached your whole body (systemic treatment ) after your cancer came back or spread
• Your head and neck cancer has returned or spread within 6 months of the last dose of platinum chemotherapy
• You have had radiotherapy in the last 30 days
• You have had chemotherapy or a biological therapy in the last 21 days
• You have had a new experimental treatment in the last 28 days
• You have had major surgery in the past 28 days (if you have had a small operation to remove some of your cancer and improve your symptoms you may still be able to take part)
• You have moderate to severe side effects from previous anti cancer treatments (apart from hair loss, changes to your skin called vitiligo and lower than normal levels of a type of white blood cell called a lymphocyte)
• You have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the past 2 weeks
• You have had an organ transplant
• You have had an autoimmune disease  in the past 3 years
• You have problems with your digestive system  such as colitis, Crohn’s disease or diverticulitis
• You have heart problems such as congestive heart failure, high blood pressure that is not controlled by medication or angina that is not controlled
• You have an active infection
• You have HIV
• You have hepatitis B or hepatitis C
• You have had tuberculosis (TB)
• You weigh less than 30 kg (4 stone 10lb)
• You are allergic to MEDI4736, tremelimumab or anything it contains
• You have had a live vaccination in the past 30 days
• You have any other serious medical condition or mental health problem that the trial team think could affect you taking part
• You are pregnant or breast feeding