A study of MIV-818 for liver cancer

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study 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 study if all of the following apply. 

• You have a type of liver cancer called hepatocellular carcinoma that has spread and cannot be removed by surgery. Or that cannot be treated with thermal ablation (RFA or MWA) and trans arterial chemoembolisation (TACE).
• Your doctor is considering treating you with lenvatinib or pembrolizumab.
• Your liver is working normally.
• You are able to look after yourself but might not be able to do heavy physical work (performance status 0 or 1). 
• You have an area of cancer the doctor can measure.
• You have satisfactory blood test results.
• You are willing to use contraception during treatment and for a time after. This is if 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 study if any of these apply. You have:

• another type of liver cancer that isn’t hepatocellular carcinoma. This includes if it is a mixed type. 
• have had more than 2 courses of treatment  for your advanced liver cancer
• cancer in more than half (50%) of the liver 
• cancer spread to the brain or spinal cord. You might be able to join if it has been treated and stable for at least 3 months. 
• had another cancer within the past 2 years. This is apart from non melanoma skin cancer  and a carcinoma in situ. 
• another cancer treatment within 4 weeks of starting the trial treatment 
• ongoing moderate to severe side effects of previous treatment. This is apart from hair loss. 

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

• have had an organ transplant  or a bone marrow transplant
• are taking medication that damps down the immune system . This is apart from a small dose of steroids. Your doctor will know how much this is.
• have HIV, hepatitis B, hepatitis C or tuberculosis (TB). You have another active infection that needs systemic treatment  such as antibiotics.
• have fluid around the abdomen (ascites) that is not well controlled or that needs to be drained often. Your doctor will know how often this is. 
• have problems with your brain such as confusion and drowsiness (encephalopathy) within 6 months before joining the trial. You cannot join if you are taking medication for encephalopathy. 
• have bleeding from your food pipe (oesophagus) within 2 weeks of joining the trial. If you are having pembrolizumab it is 12 weeks.
• are taking an experimental drug or have taken an experimental drug within 4 weeks of joining the trial
• are taking medication including herbal products that affect the CYP3A4 enzymes. This unless your medication can be changed for another that doesn’t affect these enzymes. Your doctor will know what medications affect these enzymes and if they can be changed. 
• have high blood pressure
• have a problem with bleeding or are taking medication that thins the blood
• are willing to have a heart trace (ECG ) and the results show a long QTc wave. Your doctor will arrange the ECG and will tell you the results.
• have an active autoimmune disease  and you have had systemic treatment for it in the past 2 years. This is apart from treatment that replaces something the body makes. An example is hormone replacement . 
• have inflammation of the lungs that isn’t caused by an infection or you have had treatment for this in the past
• have an increased amount of protein in your urine. Your doctor will test for this. 
• have any other medical condition or mental health problem that could affect you taking part

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

• are allergic or sensitive to any of the treatments used 
• have a live vaccine  within 30 days of starting treatment. The COVID-19 vaccines aren’t live vaccines. 
• are pregnant or breastfeeding