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) (LIVIGNO-1)

August 11, 2025 updated by: AbbVie

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Villejuif, France, 94800
        • AP-HP - Hopital Paul-Brousse /ID# 253646
    • Gironde
      • Pessac CEDEX, Gironde, France, 33604
        • Centre Hospitalier Universitaire de Bordeaux /ID# 252749
    • Herault
      • Montpellier Cedex 5, Herault, France, 34295
        • CHU Montpellier - Hopital Saint Eloi /ID# 252760
    • Ile-de-France
      • Clichy, Ile-de-France, France, 92110
        • Hopital Beaujon /ID# 252758
    • Isere
      • La Tronche, Isere, France, 38700
        • CHU Grenoble - Hopital Michallon /ID# 252755
    • Nord
      • Lille, Nord, France, 59037
        • CHRU Lille - Hopital Claude Huriez /ID# 252748
  • Italy
      • Bologna, Italy, 40138
        • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 253247
      • Palermo, Italy, 90127
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 253142
      • Roma, Italy, 00128
        • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 253141
    • Firenze
      • Florence, Firenze, Italy, 50134
        • Azienda Ospedaliero Universitaria Careggi /ID# 254444
    • Milano
      • Milan, Milano, Italy, 20132
        • IRCCS Ospedale San Raffaele /ID# 252910
    • Napoli
      • Naples, Napoli, Italy, 80147
        • P.O. Ospedale del Mare /ID# 253140
  • Japan
    • Chiba
      • Chiba-shi, Chiba, Japan, 260-8677
        • Chiba University Hospital /ID# 255190
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East /ID# 253419
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 920-8641
        • Kanazawa University Hospital /ID# 254861
    • Kanagawa
      • Yokohama shi, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center /ID# 255790
    • Osaka
      • Osakasayama-shi, Osaka, Japan, 589-8511
        • Kindai University Hospital /ID# 255106
  • Korea, Republic of
    • Gyeonggido
      • Seongnam, Gyeonggido, Korea, Republic of, 13496
        • CHA Bundang Medical Center /ID# 253054
      • Seongnam-si, Gyeonggido, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital /ID# 253412
    • Jeonranamdo
      • Hwasun-gun, Jeonranamdo, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital /ID# 253133
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
        • Asan Medical Center /ID# 253044
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
        • Samsung Medical Center /ID# 253411
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron /ID# 253063
      • Madrid, Spain, 28027
        • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 254840
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio /ID# 253074
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet /ID# 253071
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla /ID# 253059
    • Cordoba
      • Córdoba, Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia /ID# 253083
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253078
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra - Pamplona /ID# 253073
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 253451
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital /ID# 253452
      • Taichung, Taiwan, 40447
        • China Medical University Hospital /ID# 253453
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital /ID# 253676
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hosp /ID# 253450
      • Taoyuan City, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital /ID# 253674
    • Kaohsiung
      • Kaohsiung City, Kaohsiung, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital /ID# 253675
      • Kaohsiung City, Kaohsiung, Taiwan, 82445
        • E-DA Cancer Hospital /ID# 260881
    • Taipei
      • Taipei City, Taipei, Taiwan, 100
        • National Taiwan University Hospital /ID# 253449
  • United States
    • Arizona
      • Prescott Valley, Arizona, United States, 86314
        • Arizona Oncology Associates, PC - NAHOA Prescott Valley /ID# 254313
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Highlands Oncology Group, PA /ID# 253158
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles /ID# 253292
      • Orange, California, United States, 92868
        • UC Irvine /ID# 252707
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center - San Francisco - Webster Street /ID# 253291
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers - Denver Midtwon /ID# 254163
    • Florida
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando /ID# 252865
    • Illinois
      • Chicago, Illinois, United States, 60637-1443
        • The University of Chicago Medical Center /ID# 252870
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Hematology/Oncology Clinic /ID# 253851
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute /ID# 252696
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital /ID# 253342
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University-School of Medicine /ID# 252698
    • New York
      • New York, New York, United States, 10016-4744
        • NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 252708
      • New York, New York, United States, 10065-6007
        • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252705
    • North Carolina
      • Asheville, North Carolina, United States, 28806-2316
        • Messino Cancer Center - Asheville /ID# 253888
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina /ID# 252739
    • Rhode Island
      • Providence, Rhode Island, United States, 02903-4923
        • Lifespan Cancer Institute at Rhode Island Hospital /ID# 252699
    • Texas
      • Dallas, Texas, United States, 75246-2003
        • Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 252770
      • Dallas, Texas, United States, 75230
        • Duplicate_Texas Oncology - Medical City Dallas /ID# 254164
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Northeast Texas /ID# 254184

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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 2 or higher interstitial lung disease/pneumonitis.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm 1: Lenvatinib or Sorafenib
Participants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period.
Drug: Lenvatinib
Oral: Capsule
Drug: Sorafenib
Oral: Tablet
Experimental: Arm 2: Livmoniplimab Dose A + Budigalimab
Participants will receive Livmoniplimab Dose A in combination with budigalimab, as part of an approximately 2 year treatment period.
Drug: Budigalimab
Intravenous (IV) Infusion
Other Names:
  • ABBV-181
Drug: Livmoniplimab
Intravenous (IV) Infusion
Other Names:
  • ABBV-151
Experimental: Arm 3: Livmoniplimab Dose B + Budigalimab
Participants will receive Livmoniplimab Dose B in combination with budigalimab, as part of an approximately 2 year treatment period.
Drug: Budigalimab
Intravenous (IV) Infusion
Other Names:
  • ABBV-181
Drug: Livmoniplimab
Intravenous (IV) Infusion
Other Names:
  • ABBV-151

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Best Overall Response (BOR) per Investigator
Time Frame: Through Study Completion, Up to Approximately 27 Months
BOR is defined as a subject 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 27 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of response (DOR) per Investigator
Time Frame: Through Study Completion, Up to Approximately 27 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 27 Months
Number of Participants with Progression-free Survival (PFS)
Time Frame: Through Study Completion, Up to Approximately 27 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 27 Months
Overall Survival (OS)
Time Frame: Through Study Completion, Up to Approximately 27 Months
OS is defined as the time from randomization until death from any cause.
Through Study Completion, Up to Approximately 27 Months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M24-147
  • 2022-502948-13-00 (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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