Study Evaluating the Benefit of Adding Ipilimumab to the Combination of Atezolizumab and Bevacizumab in Patients With Hepatocellular Carcinoma Receiving First-line Systemic Therapy

Sponsor
Federation Francophone de Cancerologie Digestive
Study ID
NCT05665348
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • HCC - Hepatocellular Carcinoma
  • Metastatic Cancer
  • Metastatic Tumor

Eligibility Criteria

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

Interventions

  • Ipilimumab Injection — DRUG
    Administration of a combine treatment by atezolizumab and bevacizumab, with addition of ipilimumab for patients enrolled in the experimental arm
  • Atezolizumab Injection — DRUG
    One of the standard treatment's product for HCC management
  • Bevacizumab — DRUG
    One of the standard treatment's product for HCC management

Study Details

TRIPLET HCC is a phase II-III trial that assess the effectivness of addition of ipilimumab to the combination atezolizumab-bevacizumab, on global survival and response to the treatment, for patients with advanced or metastatic hepatocellular carcinoma. The theoretical duration of the study is 5 years. In the scope of this study, each patient will have 2 years of treatment and 2 years of follow-up from their enrollment date.

Key Dates

Start date
Mar 9, 2023
Status verified
Sep 2024
Primary completion
May 12, 2025
Completion
May 12, 2025

Study Design

Enrollment
229 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: DOULET ATEZOLIZUMAB-BEVACIZUMAB
    Standard treatment of HCC by the combination atezolizumab-bevacizumab, 1 cure each 3 weeks during 24 months
  • Experimental: TRIPLET ATEZOLIZUMAB BEVACIZUMAB IPILIMUMAB
    Standard treatment of HCC by the combination atezolizumab-bevacizumab with addition of ipilimumab for the 4 firsts cures of treatment each 3 weeks, then only treatment by the doublet atezolizumab-bevacizumab each 3 weeks. The total duration of treatment is 24 months.

Primary Outcome Measure

Objective response of treatment (Phase II) [ Time Frame: 24 months after beginning of treatment ]

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