A trial looking at nivolumab for people with advanced liver cancer (CA209459)

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 hepatocellular carcinoma that has got worse and cannot be cured by surgery (or by any other treatments given directly to the liver such as radiofrequency ablation, chemoembolization or alcohol injections into the liver)
• You are willing to have a sample of your cancer taken (a biopsy ) if there is no suitable sample available
• You have at least 1 area of cancer that hasn’t been treated, can be seen on a scan and measures at least 10 mm
• You have satisfactory blood tests results
• Your heart is working well
• Your liver is working normally (Child-Pugh grade A)
• You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1) 
• You are able to swallow tablets
• You are at least 18 years old
• You are willing to use reliable contraception during treatment and for 23 weeks after the final dose of nivolumab if you are a women, or 31 weeks if you are a man, if there is any possibility you or your partner could become pregnant. If you have sorafenib, the trial team will advise you how long you should use reliable contraception for

You cannot join this trial if any of these apply

• You have a type of liver cancer called fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
• Your cancer has spread to your brain, tissues surrounding your brain or your spinal cord . You might still be able to take part if you have had surgery or radiotherapy more than 28 days ago, it has not got worse in the past 4 weeks and you are no longer taking steroids
• You have had another cancer in the last 3 years apart from successfully treated early cancers (carcinoma in situ ) of the prostate, cervix or breast or successfully treated basal or squamous cell skin cancer 
• You have had treatment that reached the whole body (systemic treatment)  
• You have had treatment given directly into the liver such as radiofrequency ablation, chemoembolization or alcohol injections in the past 4 weeks
• You have had radiotherapy in the last 4 weeks (2 weeks if this was to control symptoms - palliative radiotherapy)   
• You have moderate to severe side effects from previous anti cancer treatments
• You have had major surgery in the last 4 weeks or a minor surgery such as biopsy or FNA in the past week
• You have had an organ transplant (including liver or bone marrow  transplant)
• You have problems with your thyroid that are not controlled by medication
• You have lung problems such as interstitial lung disease
• You have heart problems such as congestive heart failure, high blood pressure that is not controlled by medication, valvular heart disease, angina that is not controlled or a heart attack in the past 6 months 
• You have problems with your digestive system such as malabsorption syndrome or an active lesion (peptic ulcer) in the lining of the stomach or the food pipe (oesophagus)
• You have an autoimmune disease unless it is vitiligo, type 1 diabetes, childhood asthma that has been resolved, thyroid problems that are controlled by medications or a skin condition called psoriasis that doesn’t need treatment
• Your liver doesn’t work well and has made you confused as a result (hepatic encephalopathy) – the doctor will check for this
• You have a build up of fluid in the abdomen (ascites) that isn’t controlled by treatment
• You have had bleeding from swollen veins (varices) in the stomach or food pipe (oesophagus) in the last 6 months
• You have taken drugs that affect some enzymes called CYP3A4 (such as rifampin and St. John’s wort) in the past 7 days  
• You are taking drugs that thin your blood such as aspirin and clopidogrel 
• You have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the past 2 weeks (unless this was either a cream or an inhaler)  
• You have had severe side effects to immunotherapy treatments in the past 
• You are known to be sensitive to sorafenib, nivolumab (or any other monoclonal antibody) and anything it contains
• You have had a blood clot in the past 6 months
• You have a wound or a ulcer that is not healed or you have broken a bone in the past 3 months
• You have had severe bleeding in the past 8 weeks
• You have HIV
• You have hepatitis B, hepatitis C or hepatitis D
• You have an infection that needed treatment with antibiotics in the last 7 days
• You have any other medical condition that the trial team thinks could affect you taking part in this study
• You are pregnant or breastfeeding