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

Phase 2

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Biological: durvalumab, tremelimumab, bevacizumab

• 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

Arm && Interventions

Group	Intervention	Description
Arm A	durvalumab, tremelimumab, bevacizumab	Durvalumab (1500 mg q4w) plus tremelimumab (300 mg x 1) followed by addition of bevacizumab (15mg/kg) upon detection of radiological progression or in the absence of objective response after the second staging.
Arm B	durvalumab, tremelimumab, bevacizumab	Durvalumab plus tremelimumab followed by maintenance treatment with durvalumab and bevacizumab.

Primary Outcome Measures

Name	Time	Method
ORR	24 months	overall response rate

Secondary Outcome Measures

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

Trial Locations

Locations (3)

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

Würzburg University Hospital; 🇩🇪 Würzburg, Germany

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