A trial looking at MEDI4736, savolitinib and tremelimumab for advanced kidney cancer (CALYPSO)

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 a type of renal cell cancer called clear cell, papillary or sarcomatoid that has grown outside the kidney or spread to another part of the body
• Your cancer has grown after having had drugs that block a protein called VEGF  such as cabozantinib, pazopanib, sorafenib and sunitinib – if you have clear cell or sarcomatoid renal cell cancer
• If you have papillary renal cell cancer, you haven’t yet had drugs that block the VEGF protein (such as bevacizumab, pazopanib, sorafenib and sunitinib), or you have had it but it stopped working (treatment refractory )
• You have at least 1 area of cancer that can be seen on a CT or MRI scan and measures at least 20 mm (or 10 mm if you had a type of CT scan called a spiral CT) and it hasn’t been treated with radiotherapy . The area of cancer mustn’t be in the bones or the fluid around your tummy (abdomen), lungs or heart    
• You are willing to have a sample of your cancer taken (a biopsy ) if there is no suitable sample available
• You have satisfactory blood tests results
• You are able to swallow and absorb capsules
• You have a satisfactory heart rate
• 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 90 days after the final dose of MEDI4736 and savolitinib, if there is any possibility you or your partner could become pregnant. If you have savolitinib alone, you must use reliable contraception for 30 days after treatment

You cannot join this trial if any of these apply.

Cancer related

• Your cancer has spread to your brain and you need to have treatment such as surgery, radiotherapy or steroids 
• Your cancer has spread to the tissues (membranes) surrounding your brain (leptomeningeal disease)
• You have had treatment with cancer drugs that affect certain proteins such as PD-L1 (nivolumab), MET (cabozantinib) and CTLA (ipilimumab)
• You have had chemotherapy, immunotherapy , treatment with hormones (endocrine therapy) or a tumour embolisation  in the past 2 weeks
• You have had radiotherapy or the drugs interferon and interleukin in the past 4 weeks
• You have moderate side effects from previous cancer treatment apart from hearing loss or numbness and tingling in your hands and feet (peripheral neuropathy)
• You have had severe side effects to immunotherapy  treatment   
• You have had another cancer in the past 3 years apart from cancers that have not spread (carcinoma in situ ) of the cervix and prostate, non melanoma skin cancer or any other cancer that has been successfully treated and there is no signs of it coming back

Medical conditions

• You take warfarin
• You have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the past 3 weeks, unless it was a very small amount or an inhaler
• You have taken drugs that affect certain substances called CYP enzymes in the past 2 weeks (or 3 weeks for St John’s Wort)
• You have had a stem cell transplant  using cells from a donor (allogeneic) or an organ transplant
• You have had an autoimmune disease  that needed treatment in the past 2 years, unless it was treatment to replace something the body makes such as thyroxin, vitiligo, Grave’s disease or psoriasis that hasn’t needed treatment that reached your whole body (systemic treatment)
• You have had a major surgery in the past 4 weeks, a small operation in the past week or your doctor thinks that you might need a large operation during this trial
• You have a blood clot  and you are taking heparin  to treat this. You may be able to take part if you take a low dose (LMWH)
• You have lung problems such as infection (pneumonia) or inflammation of the lung tissue (pneumonitis ) 
• You have heart problems such as congestive heart failure that is causing symptoms, high blood pressure that is not controlled by medication, angina that is not controlled or  you have had a heart attack in the past 3 months
• You have problems with your digestive system  such as colitis, Crohn’s disease, a peptic ulcer  or gastritis
• You have type 1 diabetes
• You have hepatitis B or hepatitis C
• You have HIV
• You have or have had tuberculosis (TB)
• You have liver problems such as cirrhosis, fits (seizures) or you have an obstruction in a large vein called superior vena cava 
• You have another medical condition or mental health problem that the trial team think could affect you taking part 

Other

• You are sensitive to MEDI4736, tremelimumab, savolitinib or anything they contain
• You have had a live vaccination  in the past 30 days
• You are pregnant or breastfeeding