A Phase 2/3, Randomized Study to Evaluate the Optimized dose, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab in Subjects with Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) who have not previously received systemic treatment

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504600-28-00

Acronym

M24-052

Enrollment

Registered

2024-04-24

Start date

2024-05-09

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Metastatic Hepatocellular Carcinoma (HCC)

Brief summary

The primary endpoint for Stage 1 is the BOR of CR/PR per RECIST 1.1 by investigator., The primary endpoint for Stage 2 is OS.

Detailed description

The secondary endpoints for Stage 1 are PFS, DoR per RECIST 1.1 by investigator, OS, safety and tolerability, and PK assessments., The secondary endpoints for Stage 2 are PFS, BOR of CR/PR, and DOR per RECIST 1.1 by BICR and by investigator, PFS, BOR of CR/PR and DoR per iRECIST by BICR and by investigator; and PROs.

Interventions

DRUGTREMELIMUMAB

DRUGBudigalimab

DRUGBEVACIZUMAB

DRUGATEZOLIZUMAB

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

DRUGLivmoniplimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint for Stage 1 is the BOR of CR/PR per RECIST 1.1 by investigator., The primary endpoint for Stage 2 is OS.	—

Secondary

Measure	Time frame
The secondary endpoints for Stage 1 are PFS, DoR per RECIST 1.1 by investigator, OS, safety and tolerability, and PK assessments., The secondary endpoints for Stage 2 are PFS, BOR of CR/PR, and DOR per RECIST 1.1 by BICR and by investigator, PFS, BOR of CR/PR and DoR per iRECIST by BICR and by investigator; and PROs.	—

Countries

France, Italy, Spain

Outcome results

None listed

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