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

Sponsor
Enrico De Toni
Study ID
NCT05844046
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • durvalumab, tremelimumab, bevacizumab — BIOLOGICAL
    durvalumab, tremelimumab and bevacizumab will be administered in the respective arms either as up-front triple treatment or as combined treatment with durvalumab and tremelimumab followed by the addition of bevacizumab

Study Details

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).

Key Dates

Start date
Apr 6, 2023
Status verified
Jul 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
83 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    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.
  • Experimental: Arm B
    Durvalumab plus tremelimumab followed by maintenance treatment with durvalumab and bevacizumab.

Primary Outcome Measure

ORR [ Time Frame: 24 months ]

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