A Study to Assess the Dose, Adverse Events, and Change in Disease Activity of Livmoniplimab as an Intravenous (IV) Solution in Combination With Budigalimab as an IV Solution in Adult Participants With Hepatocellular Carcinoma (HCC)

Recruiting now · Phase 2/Phase 3

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 2 stages to this study. In Stage 1, there are 3 treatment arms 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), atezolizumab in combination with bevacizumab, or tremelimumab in combination with durvalumab. In Stage 2, there are 2 treatments arms and participants will be randomized in a 1:1 ratio. Participants will either receive livmoniplimab (optimized dose) in combination with budigalimab or tremelimumab in combination with durvalumab. Approximately 660 adult participants will be enrolled in the study across 185 sites worldwide. Stage 1: In arm 1, participants will receive intravenously (IV) infused livmoniplimab (Dose 1) in combination with IV infused budigalimab, every 3 weeks. In arm 2, participants will receive IV infused livmoniplimab (Dose 2) in combination with IV infused budigalimab, every 3 weeks. In Arm 3 (control), participants will receive the investigator's choice: IV atezolizumab in combination with IV bevacizumab every 3 weeks or single dose IV tremelimumab in combination with IV durvalumab every 4 weeks. Stage 2: In arm 1, participants will receive IV infused livmoniplimab (optimized dose) in combination with IV infused budigalimab, every 3 weeks. In Arm 2 (control), participants will receive single dose IV tremelimumab in combination with IV durvalumab every 4 weeks. All participants will continue treatment until disease progression or discontinuation criteria are met, whichever occurs first. The estimated duration of this study is about 56 months. 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

NCT06109272

Run by

AbbVie

People needed

660

Starts

2024-01-11

Expected to finish

2030-09-01

Last updated by the study team

2025-08-15

Who can join

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

You may qualify if…

• Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology or cytology or clinically by American Association for the Study of Liver Diseases criteria for participants with cirrhosis.
• Barcelona Clinic Liver Cancer (BCLC) Stage B or C.
• Child-Pugh A or B7 classification (i.e., total Child-Pugh score of 5, 6, or 7).
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

You may not qualify if…

• Prior systemic therapy for HCC.
• Symptomatic, untreated, or actively progressing CNS metastases.
• History of malignancy other than HCC.

Where it is running

• Taipei Veterans General Hosp /ID# 256169 — Taipei, Taiwan (enrolling)
• City of Hope at Orange County Lennar Foundation Cancer Center /ID# 261669 — Irvine, California, United States (enrolling)
• UC Irvine /ID# 255673 — Orange, California, United States (enrolling)
• The University of Chicago Medical Center /ID# 255674 — Chicago, Illinois, United States (enrolling)
• National Taiwan University Hospital /ID# 256168 — Taipei City, Taipei, Taiwan (enrolling)
• National Cheng Kung University Hospital /ID# 256766 — Tainan, Taiwan (enrolling)
• City of Hope /ID# 261468 — Duarte, California, United States (enrolling)
• Norton Cancer Institute /ID# 260775 — Louisville, Kentucky, United States (enrolling)
• Henry Ford Hospital /ID# 255803 — Detroit, Michigan, United States (enrolling)
• Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 256041 — Saint Louis Park, Minnesota, United States (enrolling)
• Washington University-School of Medicine /ID# 255720 — St Louis, Missouri, United States (enrolling)
• Texas Oncology - Abilene - Antilley Road /ID# 265820 — Abilene, Texas, United States (enrolling)
• Texas Oncology - Dallas - Worth Street /ID# 265806 — Dallas, Texas, United States (enrolling)
• Baylor Scott and White Research Institute /ID# 260853 — Dallas, Texas, United States (enrolling)
• Oncology and Hematology Associates of Southwest Virginia /ID# 265834 — Roanoke, Virginia, United States (enrolling)
• CHU Grenoble - Hopital Michallon /ID# 256627 — La Tronche, Isere, France (enrolling)
• Institut Gustave Roussy /ID# 258460 — Villejuif, Val-de-Marne, France (enrolling)
• Hôpital Avicenne /ID# 266005 — Bobigny, Île-de-France Region, France (enrolling)
• Hopital Beaujon /ID# 256551 — Clichy, Île-de-France Region, France (enrolling)
• IRCCS Istituto Clinico Humanitas /ID# 256684 — Rozzano, Lombardy, Italy (enrolling)
• IRCCS Ospedale San Raffaele /ID# 256404 — Milan, Milano, Italy (enrolling)
• P.O. Ospedale del Mare /ID# 256410 — Naples, Napoli, Italy (enrolling)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 265506 — Rome, Roma, Italy (enrolling)
• IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 256412 — Bologna, Italy (enrolling)
• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 256681 — Palermo, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.