Safety and Bioactivity of Ipilimumab and Nivolumab Combination Prior to Liver Resection in Hepatocellular Carcinoma — PRIME-HCC  

Hepatocellular Carcinoma Clinical Trial

Official title: PRIME-HCC: Preliminary Assessment of Safety and Bioactivity of the Ipilimumab and Nivolumab Combination Prior to Liver Resection (LR) in Hepatocellular Carcinoma (HCC)

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

• NCT number: NCT03682276
• Study type: Interventional
• Source: Imperial College London
• Contact: David J Pinato
• Phone: 02033131151
• Email: d.pinato@imperial.ac.uk
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 1, 2019
• Completion date: December 1, 2023