[M24-147] Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Budigalimab in Adult Participants With Hepatocellular Carcinoma (HCC)

[M24-147] 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 (HCC) Patients who Have Progressed After an Immune Checkpoint Inhibitor Containing Regimen in First-Line HCC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230144

Enrollment

120

Registered

2023-06-16

Start date

2023-07-29

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Hepatocellular Carcinoma

Interventions

Arm 1: Participants will receive Lenvatinib (oral, capsule) or or Sorafenib (oral, tablet), as part of an approximately 2 year treatment period. Arm 2: Participants will receive Livmoniplimab Dose A (

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Child-Pugh A classification. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. - Received an immune checkpoint inhibitor in first-line (1L) hepatocellular carcinoma (HCC) treatment regimen. - Adequate hematologic and end-organ function. - Tissue biopsy at screening. - Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies.

Exclusion criteria

Exclusion criteria: - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. - Prior treatment with an approved tyrosine kinase inhibitor (for example sorafenib or Lenvatinib) in 1L HCC treatment regimen. - History of malignancy other than hepatocellular carcinoma (HCC) within 5 years prior to screening. - Hepatic encephalopathy or requirement for medications to prevent or control encephalopathy. - Moderate or severe ascites requiring recurrent non-pharmacologic intervention to maintain symptomatic control. - Coinfection with active HBV infection and active HCV infection. - Prior history of grade 3 or higher immune-mediated adverse event or discontinuation due to immune-mediated adverse events. - Prior history of recurrent grade 3 or higher interstitial lung disease/pneumonitis.

Design outcomes

Primary

Measure	Time frame
Best Overall Response (BOR) per Investigator	—

Secondary

Measure	Time frame
Duration of response (DOR) per Investigator Number of Participants with Progression-free Survival (PFS) Overall Survival (OS)	—

Countries

France, Italy, Japan, Korea, Spain, Taiwan, United States

Contacts

Public ContactPatients and HCP Contact

AbbVie GK

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026