Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05844046

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

Led by Enrico De Toni · Updated on 2024-07-16

83

Participants Needed

3

Research Sites

195 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at study entry
  • Confirmed hepatocellular carcinoma based on tumor tissue findings
  • No prior systemic therapy for hepatocellular carcinoma
  • Not eligible for locoregional therapy for unresectable hepatocellular carcinoma
  • If progressed after locoregional therapy, it must have been completed at least 28 days before baseline scan
  • Barcelona Clinic Liver Cancer (BCLC) stage B (not eligible for locoregional therapy) or stage C
  • Child-Pugh Score class A
  • ECOG performance status of 0 or 1 at enrollment
  • At least one measurable lesion suitable for repeated measurement by CT or MRI per RECIST 1.1
  • Adequate organ and marrow function
Not Eligible

You will not qualify if you...

  • Prior study drug assignment in this study
  • Radiotherapy to more than 30% of bone marrow or wide-field radiation within 28 days before first study drug dose
  • Major surgery or significant trauma within 28 days before first study drug dose; abdominal surgery or trauma within 60 days before randomization
  • History of allogeneic organ transplantation
  • History of hepatic encephalopathy within 12 months or needing medications for it
  • Clinically meaningful ascites
  • Main portal vein thrombosis on baseline imaging
  • Symptomatic or uncontrolled hypertension
  • Active or prior autoimmune/inflammatory disorders or diverticulitis unless inactive for 5 years and approved by study physician
  • Co-infection with HBV and HCV or HBV and HDV
  • History of another primary malignancy except as allowed by protocol
  • QTcF interval 470 ms or longer on ECG
  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • History of active primary immunodeficiency
  • Live attenuated vaccine within 30 days before first study drug dose
  • Major gastrointestinal bleeding within 4 weeks before randomization
  • Untreated or incompletely treated esophageal varices at high risk of bleeding
  • Significant vascular disease requiring surgery or arterial thrombosis within 6 months before randomization
  • History of abdominal or tracheoesophageal fistula, gastrointestinal perforation, or abscess within 6 months before randomization
  • Evidence of bleeding disorders or significant coagulopathy
  • Severe nonhealing wounds, active ulcers, or untreated fractures
  • Recent use of certain antiplatelet or anticoagulant medications within 10 days before randomization
  • Pregnant or breastfeeding females, or those unwilling to use effective birth control during and after treatment
  • Prior participation in durvalumab and/or tremelimumab clinical studies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Hospital of the University of Munich

Munich, Germany, 81377

Actively Recruiting

2

Klinikum Rechts der Isar of the Technical University Munich

Munich, Germany, 81675

Actively Recruiting

3

Würzburg University Hospital

Würzburg, Germany

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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