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
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
3 other identifiers
interventional
89
6 countries
37
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.
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 Jan 2024
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2023
CompletedFirst Posted
Study publicly available on registry
October 31, 2023
CompletedStudy Start
First participant enrolled
January 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
September 22, 2026
September 1, 2026
3 years
October 26, 2023
September 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Stage 1: Best Overall Response (BOR) per Investigator
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)
OS is defined as the time from randomization until death from any cause
Through Study Completion, Up to Approximately 56 Months
Secondary Outcomes (13)
Stage 1: Number of Participants with Progression-Free Survival (PFS)
Through Study Completion, Up to Approximately 56 Months
Stage 1: Duration of Response (DOR) per Investigator
Through Study Completion, Up to Approximately 56 Months
Stage 1: Overall Survival (OS)
Through Study Completion, Up to Approximately 56 Months
Stage 1: Number of Participants with Adverse Events (AEs)
Through Study Completion, Up to Approximately 56 Months
Stage 1: Maximum Plasma Concentration (Cmax) of Livmoniplimab and Budigalimab
Through Study Completion, Up to Approximately 56 Months
- +8 more secondary outcomes
Study Arms (6)
Stage 1: Cohort 1
EXPERIMENTALParticipants will receive livmoniplimab Dose 1 in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met.
Stage 1: Cohort 2
EXPERIMENTALParticipants will receive livmoniplimab Dose 2 in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met.
Stage 1: Cohort 3 - Group 1 (Control)
ACTIVE COMPARATORParticipants will receive atezolizumab in combination with bevacizumab every 3 weeks until disease progression or until discontinuation criteria are met.
Stage 1: Cohort 3 - Group 2 (Control)
ACTIVE COMPARATORParticipants will receive a single dose of tremelimumab in combination with durvalumab every four weeks until disease progression or until discontinuation criteria are met.
Stage 2: Arm 1
EXPERIMENTALParticipants will receive livmoniplimab (optimized dose) in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met.
Stage 2: Arm 2 (Control)
ACTIVE COMPARATORParticipants will receive a single dose of tremelimumab in combination with durvalumab every 4 weeks until disease progression or until discontinuation criteria are met.
Interventions
Intravenous (IV) Solution
Intravenous (IV) Solution
Intravenous (IV) Solution
Intravenous (IV) Solution
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Prior systemic therapy for HCC.
- Symptomatic, untreated, or actively progressing CNS metastases.
- History of malignancy other than HCC.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (37)
City of Hope /ID# 261468
Duarte, California, 91010, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 261669
Irvine, California, 92618, United States
UC Irvine /ID# 255673
Orange, California, 92868, United States
The University of Chicago Medical Center /ID# 255674
Chicago, Illinois, 60637-1443, United States
Alliance for Multispecialty Research LLC Kansas City Oncology /ID# 256830
Merriam, Kansas, 66204, United States
Norton Cancer Institute /ID# 260775
Louisville, Kentucky, 40217-1395, United States
Henry Ford Hospital - Detroit /ID# 255803
Detroit, Michigan, 48202, United States
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 256041
Saint Louis Park, Minnesota, 55416, United States
Washington University-School of Medicine /ID# 255720
St Louis, Missouri, 63110, United States
Texas Oncology - Abilene - Antilley Road /ID# 265820
Abilene, Texas, 79606, United States
Texas Oncology - Dallas - Worth Street /ID# 265806
Dallas, Texas, 75246, United States
Baylor Scott and White Research Institute /ID# 260853
Dallas, Texas, 76508-0001, United States
Oncology and Hematology Associates of Southwest Virginia /ID# 265834
Roanoke, Virginia, 98684, United States
CHU Grenoble - Hopital Michallon /ID# 256627
La Tronche, Isere, 38700, France
Institut Gustave Roussy /ID# 258460
Villejuif, Val-de-Marne, 94805, France
Hopital Avicenne /ID# 266005
Bobigny, Île-de-France Region, 93000, France
Hopital Beaujon /ID# 256551
Clichy, Île-de-France Region, 92110, France
IRCCS Istituto Clinico Humanitas /ID# 256684
Rozzano, Lombardy, 20089, Italy
IRCCS Ospedale San Raffaele /ID# 256404
Milan, Milano, 20132, Italy
P.O. Ospedale del Mare /ID# 256410
Naples, Napoli, 80147, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 265506
Rome, Roma, 00168, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 256412
Bologna, 40138, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 256681
Palermo, 90127, Italy
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 256895
Roma, 00128, Italy
Puerto Rico Medical Research Center /ID# 262362
Hato Rey, Puerto Rico, 00917, Puerto Rico
Hospital Universitario Marques de Valdecilla /ID# 255769
Santander, Cantabria, 39008, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 255778
Majadahonda, Madrid, 28222, Spain
Hospital Universitario Vall de Hebron /ID# 255771
Barcelona, 08035, Spain
Hospital Universitario Reina Sofia /ID# 255779
Córdoba, 14004, Spain
Hospital General Universitario Gregorio Maranon /ID# 255772
Madrid, 28007, Spain
Hospital Universitario Virgen del Rocio /ID# 255776
Seville, 41013, Spain
Hospital Universitario Miguel Servet /ID# 255774
Zaragoza, 50009, Spain
China Medical University Hospital /ID# 256764
Taichung, 40447, Taiwan
Taichung Veterans General Hospital /ID# 259405
Taichung, 40705, Taiwan
National Cheng Kung University Hospital /ID# 256766
Tainan, 704, Taiwan
National Taiwan University Hospital /ID# 256168
Taipei, 100, Taiwan
Taipei Veterans General Hosp /ID# 256169
Taipei, 11217, Taiwan
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
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2023
First Posted
October 31, 2023
Study Start
January 11, 2024
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
September 22, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.