A trial of sunitinib and nivolumab for sarcoma (ImmunoSarc2)

The following bullet points are a summary of 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. 

Who can take part

You may be able to join this trial if you have one of the following sarcomas:

• a high grade (2 or 3) and dedifferentiated chondrosarcoma
• extra skeletal myxoid chondrosarcoma
• vascular sarcoma (including angiosarcoma, haemangioendothelioma and intimal sarcoma)
• solitary fibrous tumour
• soft tissue alveolar sarcoma
• clear cell sarcoma 

And all of the following apply. 

• Your sarcoma had spread to the nearby tissue or to another part of the body and could not be removed by surgery.
• You have had treatment with an anthracycline  chemotherapy drug. And your sarcoma has come back in the last 6 months. You might be able to join if you have just been diagnosed with sarcoma that has spread and you can’t have an anthracycline drug. For some sarcomas you can join without having had treatment. Your doctor knows which ones these are.
• You are willing to have tissue samples (biopsies ) of the sarcoma taken. 
• You have an area of sarcoma that the doctor can measure. 
• You can look after yourself but might not be able to do heavy physical work (performance status 0 or 1).
• You have satisfactory blood test results.
• You are willing to have a scan (ECHO  or MUGA ) that shows your heart works well enough to take part. Your doctor will arrange the scan and tell you the results. 
• You agree to use reliable contraception during treatment and for 6 months after if there is any chance you or your partner could become pregnant.
• You are 12 to 80 years old.  

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You have:

• had 4 or more different courses of chemotherapy  treatment 
• had another cancer in the past 5 years. This is apart from successfully treated non melanoma skin cancer  and in situ carcinoma  of the cervix. 
• cancer spread to the brain or spinal cord unless there are no symptoms and it is controlled without the use of steroids 
• had previous treatment with a PD-1, PD-L1, PD-L2 or CTLA-4 antibody. Your doctor will know if you have had one of these.
• had an immunotherapy  treatment that caused moderate to severe side effect that has affected the immune system  for example inflammation of the liver, lungs or intestine. Your doctor will know more about this. 

Medical conditions

You cannot join this trial if any of these apply. You:

• have an autoimmune disease  
• have a condition which requires you to take or you are taking medication such as steroids that affect how well your immune system works. Or if you have taken them within 2 weeks of starting treatment. This is apart from inhalers, creams or a small dose of steroids to replace what the body would make.  
• had a heart problem  in the past year or you have a heart problem that isn’t controlled  
• have hepatitis B or hepatitis C 
• have a blocked blood vessel in your lung (pulmonary embolism) 
• bruise or bleed easily. You have had a major or severe bleeding episode in the past 4 weeks. 
• are taking medication such as warfarin to thin your blood. Unless you are using low weight heparin after having a blood clot in the leg or arm and there is no sign of any bleeding problems. 
• have a problem with your thyroid gland
• have high blood pressure that isn’t controlled
• have any other medical condition or mental health problem that could affect you taking part

Other

You cannot join this trial if any of these apply. You:

• have a live vaccine  within the 30 days before joining the trial. The COVID-19 vaccine isn’t a live vaccine. 
• are allergic to any of the drugs or any of their ingredients
• are pregnant or breastfeeding