PRODIGE 81-FFCD 2101-TRIPLET: Randomized, open-label, phase II-III study evaluating the benefit of adding Ipilimumab to the combination of Atezolizumab and Bevacizumab in patients with hepatocellular carcinoma receiving first-line systemic therapy

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501217-31-00

Acronym

PRODIGE81-TRIPLET

Enrollment

574

Registered

2022-10-27

Start date

2023-03-09

Completion date

Unknown

Last updated

2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Brief summary

Phase II : objective response (complete response or partial response)within the first 24 weeks (9 cycles) for both arms treatment, Phase III : overall survival between the two arms

Detailed description

Radiation progression-free survival (PFS), Objective response rate (OR) under treatment, Rate of disease control (complete response or partial response or stability), Response time, Median time to progression, Median time to WHO degradation>2, Time to objective response, Tolerance (NCI CTC v4.0 assessed treatment and non-treatment related adverse events (bevacizumab and immunotherapy), Rate of permanent discontinuation of protocol treatment due to a study treatment-related effect., Quality of life according to the EORTC QLQ-C30 and its HCC supplement EORTC QLQ-HCC18, time to deterioration of the quality of life score., Overall survival (median) - Phase II patients

Interventions

DRUGATEZOLIZUMAB

DRUGYERVOY 5 mg/ml concentrate for solution for infusion

DRUGTecentriq 1

DRUG200 mg concentrate for solution for infusion

DRUGBEVACIZUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase II : objective response (complete response or partial response)within the first 24 weeks (9 cycles) for both arms treatment, Phase III : overall survival between the two arms	—

Secondary

Measure	Time frame
Radiation progression-free survival (PFS), Objective response rate (OR) under treatment, Rate of disease control (complete response or partial response or stability), Response time, Median time to progression, Median time to WHO degradation>2, Time to objective response, Tolerance (NCI CTC v4.0 assessed treatment and non-treatment related adverse events (bevacizumab and immunotherapy), Rate of permanent discontinuation of protocol treatment due to a study treatment-related effect., Quality of life according to the EORTC QLQ-C30 and its HCC supplement EORTC QLQ-HCC18, time to deterioration of the quality of life score., Overall survival (median) - Phase II patients	—

Measure

Time frame

—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026