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)

Running, not enrolling · Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

Hepatocellular carcinoma (HCC) is a common cancer worldwide and a leading cause of cancer-related death. The majority of participants first presenting with HCC have advanced unresectable or metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab. Livmoniplimab is an investigational drug being developed for the treatment of HCC. There are 3 treatment arms in this study and participants will be randomized in a 1:1:1 ratio. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug), lenvatinib, or sorafenib. Approximately 120 adult participants will be enrolled in the study across 60 sites worldwide. In arm 1 (control), participants will receive the investigator's choice: lenvatinib as an oral capsule or sorafenib as an oral tablet, once daily. In arm 2, participants will receive intravenously (IV) infused livmoniplimab (dose A) in combination with IV infused budigalimab, every 3 weeks. In arm 3, participants will receive intravenously (IV) infused livmoniplimab (dose B) in combination with IV infused budigalimab, every 3 weeks. The estimated duration of the study is up to 2 years There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.

Key facts

Study ID

NCT05822752

Run by

AbbVie

People needed

130

Starts

2023-09-21

Expected to finish

2026-11-01

Last updated by the study team

2025-08-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies.

You may not qualify if…

• 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 2 or higher interstitial lung disease/pneumonitis.

Where it is running

• Highlands Oncology Group, PA /ID# 253158 — Springdale, Arkansas, United States
• University of California, Los Angeles /ID# 253292 — Los Angeles, California, United States
• UC Irvine /ID# 252707 — Orange, California, United States
• California Pacific Medical Center - San Francisco - Webster Street /ID# 253291 — San Francisco, California, United States
• Rocky Mountain Cancer Centers - Denver Midtwon /ID# 254163 — Denver, Colorado, United States
• AdventHealth Orlando /ID# 252865 — Orlando, Florida, United States
• The University of Chicago Medical Center /ID# 252870 — Chicago, Illinois, United States
• Hematology/Oncology Clinic /ID# 253851 — Baton Rouge, Louisiana, United States
• Dana-Farber Cancer Institute /ID# 252696 — Boston, Massachusetts, United States
• Henry Ford Hospital /ID# 253342 — Detroit, Michigan, United States
• Washington University-School of Medicine /ID# 252698 — St Louis, Missouri, United States
• NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 252708 — New York, New York, United States
• Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252705 — New York, New York, United States
• Messino Cancer Center - Asheville /ID# 253888 — Asheville, North Carolina, United States
• University of North Carolina /ID# 252739 — Chapel Hill, North Carolina, United States
• Lifespan Cancer Institute at Rhode Island Hospital /ID# 252699 — Providence, Rhode Island, United States
• Duplicate_Texas Oncology - Medical City Dallas /ID# 254164 — Dallas, Texas, United States
• Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 252770 — Dallas, Texas, United States
• Texas Oncology - Northeast Texas /ID# 254184 — Tyler, Texas, United States
• Centre Hospitalier Universitaire de Bordeaux /ID# 252749 — Pessac, Gironde, France
• CHU Montpellier - Hopital Saint Eloi /ID# 252760 — Montpellier, Herault, France
• CHU Grenoble - Hopital Michallon /ID# 252755 — La Tronche, Isere, France
• CHRU Lille - Hopital Claude Huriez /ID# 252748 — Lille, Nord, France
• AP-HP - Hopital Paul-Brousse /ID# 253646 — Villejuif, France
• Arizona Oncology Associates, PC - NAHOA Prescott Valley /ID# 254313 — Prescott Valley, Arizona, United States

Full record on ClinicalTrials.gov

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