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
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
2 other identifiers
interventional
130
7 countries
59
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hepatocellular-carcinoma
Started Sep 2023
Typical duration for phase_2 hepatocellular-carcinoma
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2023
CompletedFirst Posted
Study publicly available on registry
April 21, 2023
CompletedStudy Start
First participant enrolled
September 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
August 14, 2025
August 1, 2025
3.1 years
April 10, 2023
August 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Overall Response (BOR) per Investigator
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 Outcomes (3)
Duration of response (DOR) per Investigator
Through Study Completion, Up to Approximately 27 Months
Number of Participants with Progression-free Survival (PFS)
Through Study Completion, Up to Approximately 27 Months
Overall Survival (OS)
Through Study Completion, Up to Approximately 27 Months
Study Arms (3)
Arm 1: Lenvatinib or Sorafenib
ACTIVE COMPARATORParticipants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period.
Arm 2: Livmoniplimab Dose A + Budigalimab
EXPERIMENTALParticipants will receive Livmoniplimab Dose A in combination with budigalimab, as part of an approximately 2 year treatment period.
Arm 3: Livmoniplimab Dose B + Budigalimab
EXPERIMENTALParticipants will receive Livmoniplimab Dose B in combination with budigalimab, as part of an approximately 2 year treatment period.
Interventions
Intravenous (IV) Infusion
Intravenous (IV) Infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (59)
Arizona Oncology Associates, PC - NAHOA Prescott Valley /ID# 254313
Prescott Valley, Arizona, 86314, United States
Highlands Oncology Group, PA /ID# 253158
Springdale, Arkansas, 72762, United States
University of California, Los Angeles /ID# 253292
Los Angeles, California, 90095, United States
UC Irvine /ID# 252707
Orange, California, 92868, United States
California Pacific Medical Center - San Francisco - Webster Street /ID# 253291
San Francisco, California, 94115, United States
Rocky Mountain Cancer Centers - Denver Midtwon /ID# 254163
Denver, Colorado, 80218, United States
AdventHealth Orlando /ID# 252865
Orlando, Florida, 32803, United States
The University of Chicago Medical Center /ID# 252870
Chicago, Illinois, 60637-1443, United States
Hematology/Oncology Clinic /ID# 253851
Baton Rouge, Louisiana, 70809, United States
Dana-Farber Cancer Institute /ID# 252696
Boston, Massachusetts, 02215, United States
Henry Ford Hospital /ID# 253342
Detroit, Michigan, 48202, United States
Washington University-School of Medicine /ID# 252698
St Louis, Missouri, 63110, United States
NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 252708
New York, New York, 10016-4744, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252705
New York, New York, 10065-6007, United States
Messino Cancer Center - Asheville /ID# 253888
Asheville, North Carolina, 28806-2316, United States
University of North Carolina /ID# 252739
Chapel Hill, North Carolina, 27514, United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 252699
Providence, Rhode Island, 02903-4923, United States
Duplicate_Texas Oncology - Medical City Dallas /ID# 254164
Dallas, Texas, 75230, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 252770
Dallas, Texas, 75246-2003, United States
Texas Oncology - Northeast Texas /ID# 254184
Tyler, Texas, 75702, United States
Centre Hospitalier Universitaire de Bordeaux /ID# 252749
Pessac, Gironde, 33604, France
CHU Montpellier - Hopital Saint Eloi /ID# 252760
Montpellier, Herault, 34295, France
CHU Grenoble - Hopital Michallon /ID# 252755
La Tronche, Isere, 38700, France
CHRU Lille - Hopital Claude Huriez /ID# 252748
Lille, Nord, 59037, France
AP-HP - Hopital Paul-Brousse /ID# 253646
Villejuif, 94800, France
Hopital Beaujon /ID# 252758
Clichy, Île-de-France Region, 92110, France
Azienda Ospedaliero Universitaria Careggi /ID# 254444
Florence, Firenze, 50134, Italy
IRCCS Ospedale San Raffaele /ID# 252910
Milan, Milano, 20132, Italy
P.O. Ospedale del Mare /ID# 253140
Naples, Napoli, 80147, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 253247
Bologna, 40138, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 253142
Palermo, 90127, Italy
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 253141
Roma, 00128, Italy
Chiba University Hospital /ID# 255190
Chiba, Chiba, 260-8677, Japan
National Cancer Center Hospital East /ID# 253419
Kashiwa-shi, Chiba, 277-8577, Japan
Kanazawa University Hospital /ID# 254861
Kanazawa, Ishikawa-ken, 920-8641, Japan
Yokohama City University Medical Center /ID# 255790
Yokohama, Kanagawa, 232-0024, Japan
Kindai University Hospital /ID# 255106
Osakasayama-shi, Osaka, 589-8511, Japan
CHA Bundang Medical Center /ID# 253054
Seongnam, Gyeonggido, 13496, South Korea
Seoul National University Bundang Hospital /ID# 253412
Seongnam-si, Gyeonggido, 13620, South Korea
Chonnam National University Hwasun Hospital /ID# 253133
Hwasun-gun, Jeonranamdo, 58128, South Korea
Asan Medical Center /ID# 253044
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Samsung Medical Center /ID# 253411
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Hospital Universitario Marques de Valdecilla /ID# 253059
Santander, Cantabria, 39008, Spain
Hospital Universitario Reina Sofia /ID# 253083
Córdoba, Cordoba, 14004, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253078
Majadahonda, Madrid, 28222, Spain
Clinica Universidad de Navarra - Pamplona /ID# 253073
Pamplona, Navarre, 31008, Spain
Hospital Universitario Vall d'Hebron /ID# 253063
Barcelona, 08035, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 254840
Madrid, 28027, Spain
Hospital Universitario Virgen del Rocio /ID# 253074
Seville, 41013, Spain
Hospital Universitario Miguel Servet /ID# 253071
Zaragoza, 50009, Spain
E-DA Cancer Hospital /ID# 260881
Kaohsiung City, Kaohsiung, 82445, Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 253675
Kaohsiung City, Kaohsiung, 833, Taiwan
National Taiwan University Hospital /ID# 253449
Taipei City, Taipei, 100, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 253451
Kaohsiung City, 807, Taiwan
China Medical University Hospital /ID# 253453
Taichung, 40447, Taiwan
Taichung Veterans General Hospital /ID# 253452
Taichung, 40705, Taiwan
National Cheng Kung University Hospital /ID# 253676
Tainan, 704, Taiwan
Taipei Veterans General Hosp /ID# 253450
Taipei, 11217, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 253674
Taoyuan, 333, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2023
First Posted
April 21, 2023
Study Start
September 21, 2023
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
August 14, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.