A trial looking at volrustomig, bevacizumab and lenvatinib for liver cancer that has spread (GEMINI-Hepatobiliary - Sub study one)

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 has spread into surrounding tissues, to another part of the body or you can’t have surgery to remove it. 
• You have many tumours in your liver, but you feel well. This is BCLC stage B liver cancer. Or you have cancer that has spread, or you feel less well. This is BCLC stage C liver cancer. 
• Your liver is working normally.
• You have at least 1 area of cancer that your doctor can measure on a scan that hasn’t been treated with radiotherapy. 
• There is a sample of tissue that the trial team can access or you are willing to give a new sample.
• You weigh more than 35kg.
• You are active 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 use reliable contraception during treatment and for a period after if there is any chance you or your partner could become pregnant.

Who can’t take part

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

• have fibrolamellar or sarcomatoid hepatocellular liver cancer or you have a mix of bile duct cancer and hepatocellular liver cancer. Your doctor will know this. 
• have cancer that has spread to the brain or spinal cord or the thin tissues that cover the them
• have spinal cord compression
• are suitable to have local treatment to the liver such as heat treatment to destroy liver cancer 
• have had or are having chemotherapy, a targeted cancer drug  or hormone therapy to treat your cancer 
• have had an immunotherapy or a similar drug in the past 
• have had another cancer in the past unless there have been no signs of it in the last 5 years and there is a low chance of it coming back. You can take part if you have had successfully treated non melanoma skin cancer , lentigo maligna melanoma or carcinoma in situ (CIS ).
• are taking an experimental drug or using a device as part of another clinical trial
• have already taken part in this trial 

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

• had changes in the brain that can occur with liver disease within a year of being put into a treatment group or you are taking medication to stop this happening. Your doctor will know this. 
• have had a heart attack in the last 6 months or another significant heart problem  that isn’t well controlled with medication. Your doctor checks your heart before you join the trial. 
• have had a stroke  in the last 6 months
• have a serious wound, a wound that isn’t getting better or you have had a tummy ulcer  or bone fracture  within a month of being put into a treatment group
• have had a blood clot  in your lower leg or lung or a serious clot that developed in another part of the body within 3 months of being put into a treatment group
• are taking or have recently taken medication to treat a blood clot. You might be able to take part if you are taking medication to prevent a this.
• have inflammation of the blood vessels, a significant bleeding disorder or a significant bleed from your digestive tract within 6 months of being put into a treatment group
• have had an organ transplant  or you are on the waiting list to have one 
• have or had an autoimmune condition  that needs treatment apart from certain ones. Your doctor will know about this. 
• have or had an inflammatory disorder such as Crohn’s disease
• have a problem with how your immune system  works 
• have HIV, tuberculosis, or any other active infection that needs treatment. You cannot join if you have both hepatitis B and hepatitis D. You can join if you have only hepatitis B or only hepatitis C that is being controlled with medication. 
• have bad side effects from past treatments that aren’t getting better. You can join if these are hair loss, loss of skin pigment (vitiligo) or other side effects that won’t get worse if you have the trial drug. 
• have scarring of the lungs
• developed a hole or fistula in your digestive tract within 6 months of being put into a treatment group
• can’t swallow tablets, keep them down or you have any other condition that affects how you absorb medication
• have a problem with how your kidneys work
• have a long term medical condition that means you have a lot of diarrhoea
• have a collection of fluid around the tummy area (abdomen) and you had it drained within 6 months but it came back. You might be able to take part if you are on a stable dose of medication for at least 2 months to treat this. 
• have had major surgery within 28 days of starting trial treatment 
• have had treatment that damps down the immune system unless it is a low dose 
• have had radiotherapy to more than 30% of your bone marrow or to a wide area in the last 28 days 
• have a lot of protein in your urine
• have any other medical condition or mental health problem that the trial team think could affect you taking part 

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

• are allergic to bevacizumab, lenvatinib, volrustomig or anything they contain 
• have had a live vaccine within 30 days of the first dose of trial treatment. You can have the approved COVID-19 vaccines as these aren’t live. 
• have had a herbal medication for liver cancer within 14 days of trial treatment 
• are pregnant or breastfeeding or you plan to become pregnant