A trial of AZD5069 and durvalumab for cancer that started in the liver (CUBIC)

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 all of the following apply.

• You have hepatocellular liver cancer that is not suitable for surgery. Your doctor will know this. 
• You are suitable to have treatment that reaches the whole body (systemic treatment) .
• This is your first treatment for liver cancer or you have already had treatment that included sorafenib, lenvatinib, an immunotherapy or certain targeted drugs. If you had treatment, your cancer got worse after no more than one course of treatment or you had to stop due to side effects. The team check which drugs you have had and for how long. 
• You are willing to have up to 2 biopsies  from your liver to give tissue for the trial team to do some tests on. 
• Your doctor can measure the cancer on a scan.
• Your liver is working normally (Child-Pugh score A).
• Your kidneys are working well.
• You can swallow tablets.
• You have satisfactory blood test results.
• You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1).
• You are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant.
• You are at least 18 years old.

Who can’t take part

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

• have had moderate to severe side effects to past treatment or you had to stop treatment due to side effects caused by an immunotherapy
• have had treatment for your cancer within 4 weeks of starting trial treatment 
• have had an experimental treatment within 28 days of starting trial treatment or it hasn’t completely cleared your body 
• are taking part in another clinical trial unless it doesn’t involve a treatment 
• have had another cancer that has got worse or needed treatment in the past 5 years unless it has a low chance of coming back. You can join if it was successfully treated non melanoma skin cancer , prostate cancer, carcinoma in situ  of the cervix, or DCIS  of the breast

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

• have had a heart attack in the last 12 months or a significant heart problem  that needs treatment. The trial team check if you have a heart condition before you join the trial. 
• have had a stroke  or mini stroke in the last 12 months
• have a problem with your digestive system  or a blockage that means you can’t absorb AZD5069
• have an active hepatitis B infection unless you are having treatment, an active hepatitis C infection unless it has been successfully treated or any other severe infection that needs treatment 
• have had major surgery in the last 2 weeks
• have had treatment that damps down the immune system . This includes steroids  within 2 weeks of starting trial treatment unless it was a low dose.
• have a problem with how your immune system works 
• have had an organ transplant  in the past 
• have an autoimmune condition  that needs treatment apart from certain ones. Your doctor will know about this. 
• have or had scarring on the lungs or active inflammation of the lungs (pneumonitis)  that needed steroid treatment 
• have any other medical condition or mental health problem that the trial team think could affect you taking part in this trial

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

• weigh 30kg or less
• are allergic to AZD5069, durvalumab or anything they contain
• are taking drugs that affect enzymes called CYP3A4
• have had a live vaccination  within 30 days of the start of trial treatment. Please note, the current approved COVID-19 vaccines are allowed as they aren’t live. 
• are pregnant or breastfeeding