Safety and Bioactivity of Ipilimumab and Nivolumab Combination Prior to Liver Resection in Hepatocellular Carcinoma

Summary

Participation Requirements

Description

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...

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.

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