Sequential or Up-front Triple Treatment With Durvalumab, Tremelimumab and Bevacizumab for Non-resectable Hepatocellular Carcinoma (HCC) Patients

Phase 2

Recruiting

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT05844046
• Lead Sponsor: Enrico De Toni

Brief Summary

This is a randomized, open-label, multi-center, international, Phase II study to assess the efficacy and safety of sequential or up-front triple treatment with durvalumab, tremelimumab and bevacizumab for non-resectable hepatocellular carcinoma.

Patients will be randomized in a 1:1 ratio to one of the following arms:

Arm A: initial treatment with durvalumab plus tremelimumab followed by treatment escalation with the addition of bevacizumab upon radiological progression or in the absence of objective response

Arm B: up-front treatment with durvalumab, tremelimumab and bevacizumab

Patients will be stratified according to macrovascular invasion and etiology of liver disease (viral etiologies versus others).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-06
• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-05-03
• Study First Posted: 2023-05-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-13
• Last Update Posted: 2024-07-16
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ORR	24 months	overall response rate

Secondary Outcome Measures

Name	Time	Method
PFS	24 months	Progression-free survival
TTP	24 months	Time to progression
ORR-BICR	24 months	Objective response rate acc. to BICR
mOS	24 months	median overall survival

Trial Locations

Locations (3)

Hospital of the University of Munich; 🇩🇪 Munich, Germany

Klinikum Rechts der Isar of the Technical University Munich; 🇩🇪 Munich, Germany

Würzburg University Hospital; 🇩🇪 Würzburg, Germany