NCT03682276

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Ipilimumab	Ipilimumab is a monoclonal antibody given as an immunotherapy
BIOLOGICAL	Nivolumab	Nivolumab is a monoclonal antibody given as an immunotherapy

Timeline

• Start date: 2019-03-01
• Primary completion: 2023-09-01
• Completion: 2023-12-01
• First posted: 2018-09-24
• Last updated: 2022-12-13

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study