NCT04268888

Nivolumab in Combination With TACE/TAE for Patients With Intermediate Stage HCC

A Two-arm Multi-stage (TAMS) Seamless Phase II/III Randomised Trial of Nivolumab in Combination With TACE/TAE for Patients With Intermediate Stage HCC

• Status: Suspended
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 522 (estimated)
• Sponsor: The Clatterbridge Cancer Centre NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the addition of nivolumab to TACE/TAE in the treatment of patients with intermediate stage hepatocellular carcinoma. All patients will receive TACE/TAE and half will receive nivolumab.

Detailed description

A significant proportion of HCC patients present with, or progress to, intermediate stage disease and these patients are typically treated with transarterial chemo-embolisation (TACE) or transarterial embolisation (TAE). However, since TACE/TAE is generally a palliative therapy, it provides a potential backbone for the addition of effective systemic therapies with the aim of improving survival outcomes. Since TACE may liberate an abundance of tumour antigens and 'danger' signals, it may lend itself to combination with immunotherapeutic strategies. Nivolumab is a human monoclonal antibody. Nivolumab targets the programmed death-1 PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab and TACE/TAE	Immunotherapy and TACE/TAE
PROCEDURE	TACE/TAE	TACE/TAE (as per local practice)

Timeline

• Start date: 2019-05-08
• Primary completion: 2025-08-01
• Completion: 2026-06-30
• First posted: 2020-02-13
• Last updated: 2025-02-26

Locations

2 sites across 2 countries: France, United Kingdom

Regulatory

• FDA-regulated drug study