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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

September 21, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

April 10, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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