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) (LIVIGNO-2)

August 12, 2025 updated by: AbbVie

A Phase 2/3, Randomized Study to Evaluate the Dose Optimization, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab in Subjects With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Treatment

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

660

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Ile-de-France
      • Bobigny, Ile-de-France, France, 93000
        • Recruiting
        • Hôpital Avicenne /ID# 266005
      • Clichy, Ile-de-France, France, 92110
        • Recruiting
        • Hopital Beaujon /ID# 256551
    • Isere
      • La Tronche, Isere, France, 38700
        • Recruiting
        • CHU Grenoble - Hopital Michallon /ID# 256627
    • Val-de-Marne
      • Villejuif Cedex, Val-de-Marne, France, 94805
        • Recruiting
        • Institut Gustave Roussy /ID# 258460
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 256412
      • Palermo, Italy, 90127
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 256681
      • Roma, Italy, 00128
        • Recruiting
        • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 256895
    • Lombardia
      • Rozzano, Lombardia, Italy, 20089
        • Recruiting
        • IRCCS Istituto Clinico Humanitas /ID# 256684
    • Milano
      • Milan, Milano, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele /ID# 256404
    • Napoli
      • Naples, Napoli, Italy, 80147
        • Recruiting
        • P.O. Ospedale del Mare /ID# 256410
    • Roma
      • Rome, Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 265506
  • Puerto Rico
      • Hato Rey, Puerto Rico, 00917
        • Recruiting
        • Puerto Rico Medical Research Center /ID# 262362
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron /ID# 255771
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Maranon /ID# 255772
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio /ID# 255776
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet /ID# 255774
        • Contact:
          • Site Coordinator
          • Phone Number: 976 76 55 00
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla /ID# 255769
    • Cordoba
      • Córdoba, Cordoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia /ID# 255779
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 255778
  • Taiwan
      • Taichung, Taiwan, 40447
        • Active, not recruiting
        • China Medical University Hospital /ID# 256764
      • Taichung, Taiwan, 40705
        • Active, not recruiting
        • Taichung Veterans General Hospital /ID# 259405
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital /ID# 256766
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hosp /ID# 256169
    • Taipei
      • Taipei City, Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital /ID# 256168
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope /ID# 261468
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope at Orange County Lennar Foundation Cancer Center /ID# 261669
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine /ID# 255673
    • Illinois
      • Chicago, Illinois, United States, 60637-1443
        • Recruiting
        • The University of Chicago Medical Center /ID# 255674
    • Kansas
      • Merriam, Kansas, United States, 66204
        • Completed
        • Alliance for Multispecialty Research LLC Kansas City Oncology /ID# 256830
    • Kentucky
      • Louisville, Kentucky, United States, 40217-1395
        • Recruiting
        • Norton Cancer Institute /ID# 260775
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital /ID# 255803
        • Contact:
          • Site Coordinator
          • Phone Number: (313) 916-8423
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 256041
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University-School of Medicine /ID# 255720
    • Texas
      • Abilene, Texas, United States, 79606
        • Recruiting
        • Texas Oncology - Abilene - Antilley Road /ID# 265820
      • Dallas, Texas, United States, 76508-0001
        • Recruiting
        • Baylor Scott and White Research Institute /ID# 260853
        • Contact:
          • Site Coordinator
          • Phone Number: 254-724-1054
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology - Dallas - Worth Street /ID# 265806
    • Virginia
      • Roanoke, Virginia, United States, 98684
        • Recruiting
        • Oncology and Hematology Associates of Southwest Virginia /ID# 265834

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Livmoniplimab
Intravenous (IV) Solution
Other Names:
  • ABBV-151
Drug: Budigalimab
Intravenous (IV) Solution
Other Names:
  • ABBV-181
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.
Drug: Livmoniplimab
Intravenous (IV) Solution
Other Names:
  • ABBV-151
Drug: Budigalimab
Intravenous (IV) Solution
Other Names:
  • ABBV-181
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.
Drug: Atezolizumab
Intravenous (IV) Solution
Drug: Bevacizumab
Intravenous (IV) Solution
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.
Drug: Durvalumab
Intravenous (IV) Solution
Drug: Tremelimumab
Intravenous (IV) Solution
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.
Drug: Livmoniplimab
Intravenous (IV) Solution
Other Names:
  • ABBV-151
Drug: Budigalimab
Intravenous (IV) Solution
Other Names:
  • ABBV-181
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.
Drug: Durvalumab
Intravenous (IV) Solution
Drug: Tremelimumab
Intravenous (IV) Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage 1: Best Overall Response (BOR) per Investigator
Time Frame: Through Study Completion, Up to Approximately 56 Months
BOR is defined as a participant achieving confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by investigators at any time prior to subsequent anticancer therapy.
Through Study Completion, Up to Approximately 56 Months
Stage 2: Overall Survival (OS)
Time Frame: Through Study Completion, Up to Approximately 56 Months
OS is defined as the time from randomization until death from any cause
Through Study Completion, Up to Approximately 56 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage 1: Number of Participants with Progression-Free Survival (PFS)
Time Frame: Through Study Completion, Up to Approximately 56 Months
PFS is defined as 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.
Through Study Completion, Up to Approximately 56 Months
Stage 1: Duration of Response (DOR) per Investigator
Time Frame: Through Study Completion, Up to Approximately 56 Months
DOR is defined as the time from first confirmed CR or PR until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.
Through Study Completion, Up to Approximately 56 Months
Stage 1: Overall Survival (OS)
Time Frame: Through Study Completion, Up to Approximately 56 Months
OS is defined as the time from randomization until death from any cause.
Through Study Completion, Up to Approximately 56 Months
Stage 1: Number of Participants with Adverse Events (AEs)
Time Frame: Through Study Completion, Up to Approximately 56 Months
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Through Study Completion, Up to Approximately 56 Months
Stage 1: Maximum Plasma Concentration (Cmax) of Livmoniplimab and Budigalimab
Time Frame: Through Study Completion, Up to Approximately 56 Months
Cmax of livmoniplimab and budigalimab.
Through Study Completion, Up to Approximately 56 Months
Stage 1: Time to Cmax (Tmax) of Livmoniplimab and Budigalimab
Time Frame: Through Study Completion, Up to Approximately 56 Months
Tmax of livmoniplimab and budigalimab.
Through Study Completion, Up to Approximately 56 Months
Stage 1: Area Under the Serum Concentration Versus Time Curve (AUC) of Livmoniplimab and Budigalimab
Time Frame: Through Study Completion, Up to Approximately 56 Months
AUC of livmoniplimab and budigalimab.
Through Study Completion, Up to Approximately 56 Months
Stage 2: Number of Participants with Progression-Free Survival (PFS)
Time Frame: Through Study Completion, Up to Approximately 56 Months
PFS is defined as the time from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined blinded independent central review (BICR) or death from any cause, whichever occurs first.
Through Study Completion, Up to Approximately 56 Months
Stage 2: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) per BICR
Time Frame: Through Study Completion, Up to Approximately 56 Months
BOR is defined as a participant achieving confirmed CR/PR per RECIST 1.1 as determined by BICR at any time prior to subsequent anticancer therapy.
Through Study Completion, Up to Approximately 56 Months
Change from Baseline in the Pain Domain of the European Organization for Research Treatment of Cancer Quality of Life Questionnaire Hepatocellular Carcinoma 18-Question Module (EORTC QLQ-HCC18)
Time Frame: Baseline to Week 12
The EORTC QLQ-HCC18 is an 18-item scale that measures hepatocellular carcinoma (HCC)-specific symptoms and health-related quality of life (HRQoL). The Pain Domain contains 2 items where scores are based on a 4-point Likert scale (with 1 = 'not at all' to 4 = 'very much'); scaled scores for each domain ranged from 0-100 with a higher score indicating worse symptoms.
Baseline to Week 12
Change from Baseline in the Fatigue Domain of the EORTC QLQ-HCC18
Time Frame: Baseline to Week 12
The EORTC QLQ-HCC18 is an 18-item scale that measures HCC-specific symptoms and HRQoL. The Fatigue Domain contains 3 items where scores are based on a 4-point Likert scale (with 1 = 'not at all' to 4 = 'very much'); scaled scores for each domain ranged from 0-100 with a higher score indicating worse symptoms.
Baseline to Week 12
Change from Baseline in Physical Function (PF) Domain of the European Organization for Research Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)
Time Frame: Baseline to Week 12
The EORTC QLQ-C30 is an 30-item patient-reported questionnaire that measures symptoms and HRQoL. The PF Domain is a functional scale where participants rate items on a 4-point scale (with 1 = 'not at all' to 4 = 'very much'). A change of 5 to 10 points is considered a small change and the lower bound (5) will be used to define the minimum important difference. A change of >= 10 to < 20 points is considered a moderate change.
Baseline to Week 12
Change from Baseline in Global Health Status (GHS)/Quality of Life (QoL) Domain as Measured by the GHS/QoL Domain of the EORTC QLQ-C30
Time Frame: Baseline to Week 12
The EORTC QLQ-C30 is an 30-item patient-reported questionnaire that measures symptoms and HRQoL. The GHS/QoL Domain is a scale where participants rate items on a 4-point scale (with 1 = 'not at all' to 4 = 'very much'). A change of 5 to 10 points is considered a small change and the lower bound (5) will be used to define the minimum important difference. A change of ≥ 10 to < 20 points is considered a moderate change.
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2024

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M24-052
  • 2023-504600-28-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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