This is a single-arm, open-label study to be conducted in 32 patients at a small number of UK hospitals. The study is in 2 parts: Part 1 will confirm, in a small number of patients, that the treatment regimen is safe and doesn't result in unacceptable delay to liver resection. Part 2 will expand the number of patients studied, and provide the opportunity to assess survival over about 2 years after liver resection. The decision to proceed to Part 2 will be taken with advice from an independent, expert committee.~Patients with early-stage HCC will first undergo screening procedures during a 28-day time window between giving consent and starting drug treatment. Screening procedures will include:~Medical interview and physical exam~ECG~Tumour biopsy~Tumour imaging by MRI~Tumour imaging by CT~Blood and urine samples~Stool sample (optional)~Patients meeting the protocol-specified criteria will be enrolled and on Day 1 will have the following:~Medical interview, and physical exam (if required)~Blood and urine samples~Intravenous dose of ipilimumab ('YERVOY') 1 milligram per kilogram body weight~Intravenous dose of nivolumab ('OPDIVO') 3 milligrams per kilogram body weight~On Day 22 the participants will have the following:~Medical interview, and physical exam (if required)~Blood and urine samples~Intravenous dose of nivolumab ('OPDIVO') 3 milligrams per kilogram body weight~On Day 43 the participants will have the following:~Medical interview, and physical exam (if required)~ECG~Tumour imaging by MRI~Blood and urine samples~Stool sample (optional)~Patients who remain eligible for liver resection will likely undergo surgery within a few days of the Day 43 visit.~On Day 127 the participants will have the following:~Medical interview, and physical exam (if required)~Tumour imaging by MRI~Blood and urine samples~Every 4 months thereafter until 2 years later, or until starting another anti-cancer treatment, participants will have tumour imaging by MRI.
The PRIME-HCC trial will assess the effects of combination treatment with nivolumab (OPDIVO) and ipilimumab (YERVOY) pre-operatively in hepatocellular carcinoma patients for whom liver resection is planned. The trial will be conducted at a small number of National Health Service hospitals in the UK. Participants will receive two doses of nivolumab and a single dose of ipilimumab in the weeks before their planned surgery.