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A Phase 2, Randomized Study to Evaluate the Optimized Dose, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab for locally advanced or Metastatic Hepatocellular Carcinoma patients who have progressed after an approved immune checkpoint inhibitor containing regimen in First-Line HCC

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502948-13-00
Acronym
M24-147
Enrollment
63
Registered
2023-11-15
Start date
2024-03-01
Completion date
Unknown
Last updated
2025-12-04

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

Conditions

Hepatocellular Carcinoma

Brief summary

The primary endpoint is the BOR of confirmed CR or confirmed PR per RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy.

Detailed description

The secondary endpoints are DoR by investigators, PFS by investigators, and OS., PFS by investigators: The time from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first., OS: The time from randomization until death from any cause.

Interventions

DRUGBudigalimab
DRUGSorafenib STADA 200 mg Filmtabletten

Sponsors

Abbvie Deutschland GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the BOR of confirmed CR or confirmed PR per RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy.

Secondary

MeasureTime frame
The secondary endpoints are DoR by investigators, PFS by investigators, and OS., PFS by investigators: The time from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first., OS: The time from randomization until death from any cause.

Countries

France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 6, 2026