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

Sponsor
Imperial College London
Study ID
NCT03682276
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — BIOLOGICAL
    Ipilimumab is a monoclonal antibody given as an immunotherapy
  • Nivolumab — BIOLOGICAL
    Nivolumab is a monoclonal antibody given as an immunotherapy

Study Details

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.

Key Dates

First listed
Sep 24, 2018
Start date
Mar 1, 2019
Status verified
Jun 2026
Primary completion
Mar 12, 2026
Completion
Mar 12, 2026

Study Design

Enrollment
33 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group
    Ipilimumab, solution for infusion, 1 milligram per kilogram body weight, once every 3 weeks, for 3 weeks; Nivolumab, solution for infusion, 3 milligrams per kilogram body weight, once every 3 weeks, for 6 weeks

Primary Outcome Measure

Delay to Surgery [ Time Frame: Up to Day 89 ]

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