Recruiting
Phase 2
Phase 3

Livmoniplimab & Budigalimab

Sponsor:

AbbVie

Code:

NCT06109272

Conditions

Hepatocellular Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Livmoniplimab

Budigalimab

Durvalumab

Atezolizumab

Bevacizumab

Study Details

Brief summary:

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.

Conditions

Hepatocellular Carcinoma

Study ID

NCT06109272

Start date

Jan 11, 2024

Status verified date

Aug, 2025

Completion date

Sep, 2030

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Design

Enrollment

660 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stage 1: Cohort 1

Participants will receive livmoniplimab Dose 1 in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met.

experimental: Stage 1: Cohort 2

Participants will receive livmoniplimab Dose 2 in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met.

active comparator: Stage 1: Cohort 3 - Group 1 (Control)

Participants will receive atezolizumab in combination with bevacizumab every 3 weeks until disease progression or until discontinuation criteria are met.

active comparator: Stage 1: Cohort 3 - Group 2 (Control)

Participants will receive a single dose of tremelimumab in combination with durvalumab every four weeks until disease progression or until discontinuation criteria are met.

experimental: Stage 2: Arm 1

Participants will receive livmoniplimab (optimized dose) in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met.

active comparator: Stage 2: Arm 2 (Control)

Participants will receive a single dose of tremelimumab in combination with durvalumab every 4 weeks until disease progression or until discontinuation criteria are met.

Interventions

Livmoniplimab

Intravenous (IV) Solution

Budigalimab

Intravenous (IV) Solution

Durvalumab

Intravenous (IV) Solution

Atezolizumab

Intravenous (IV) Solution

Bevacizumab

Intravenous (IV) Solution

Tremelimumab

Intravenous (IV) Solution

Primary outcome measure

  • Stage 1: Best Overall Response (BOR) per Investigator [ Time Frame: Through Study Completion, Up to Approximately 56 Months ]
  • Stage 2: Overall Survival (OS) [ Time Frame: Through Study Completion, Up to Approximately 56 Months ]

Central Contacts and Locations

Central contacts

Locations

City of Hope /ID# 261468

Recruiting

Duarte, California, United States, 91010

City of Hope at Orange County Lennar Foundation Cancer Center /ID# 261669

Recruiting

Irvine, California, United States, 92618

UC Irvine /ID# 255673

Recruiting

Orange, California, United States, 92868

The University of Chicago Medical Center /ID# 255674

Recruiting

Chicago, Illinois, United States, 60637-1443

Norton Cancer Institute /ID# 260775

Recruiting

Louisville, Kentucky, United States, 40217-1395

Henry Ford Hospital /ID# 255803

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Site Coordinator

(313) 916-8423

Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 256041

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Washington University-School of Medicine /ID# 255720

Recruiting

St Louis, Missouri, United States, 63110

Texas Oncology - Abilene - Antilley Road /ID# 265820

Recruiting

Abilene, Texas, United States, 79606

Texas Oncology - Dallas - Worth Street /ID# 265806

Recruiting

Dallas, Texas, United States, 75246

Baylor Scott and White Research Institute /ID# 260853

Recruiting

Dallas, Texas, United States, 76508-0001

Contacts

Site Coordinator

254-724-1054

Oncology and Hematology Associates of Southwest Virginia /ID# 265834

Recruiting

Roanoke, Virginia, United States, 98684

More Information

Sponsor

AbbVie

Last update posted

Aug 15, 2025

Last verified

Aug, 2025

Keywords

  • Hepatocellular Carcinoma
  • Livmoniplimab
  • ABBV-151
  • budigalimab
  • ABBV-181

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2025-08-15.