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)
NCT ID: NCT06109272
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
660 participants
INTERVENTIONAL
2024-01-11
2030-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
Livmoniplimab
Intravenous (IV) Solution
Budigalimab
Intravenous (IV) Solution
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.
Livmoniplimab
Intravenous (IV) Solution
Budigalimab
Intravenous (IV) Solution
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.
Atezolizumab
Intravenous (IV) Solution
Bevacizumab
Intravenous (IV) Solution
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.
Durvalumab
Intravenous (IV) Solution
Tremelimumab
Intravenous (IV) Solution
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.
Livmoniplimab
Intravenous (IV) Solution
Budigalimab
Intravenous (IV) Solution
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.
Durvalumab
Intravenous (IV) Solution
Tremelimumab
Intravenous (IV) Solution
Interventions
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Livmoniplimab
Intravenous (IV) Solution
Budigalimab
Intravenous (IV) Solution
Durvalumab
Intravenous (IV) Solution
Atezolizumab
Intravenous (IV) Solution
Bevacizumab
Intravenous (IV) Solution
Tremelimumab
Intravenous (IV) Solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Symptomatic, untreated, or actively progressing CNS metastases.
* History of malignancy other than HCC.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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City of Hope /ID# 261468
Duarte, California, United States
City of Hope at Orange County Lennar Foundation Cancer Center /ID# 261669
Irvine, California, United States
UC Irvine /ID# 255673
Orange, California, United States
The University of Chicago Medical Center /ID# 255674
Chicago, Illinois, United States
Alliance for Multispecialty Research LLC Kansas City Oncology /ID# 256830
Merriam, Kansas, United States
Norton Cancer Institute /ID# 260775
Louisville, Kentucky, United States
Henry Ford Hospital /ID# 255803
Detroit, Michigan, United States
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 256041
Saint Louis Park, Minnesota, United States
Washington University-School of Medicine /ID# 255720
St Louis, Missouri, United States
Texas Oncology - Abilene - Antilley Road /ID# 265820
Abilene, Texas, United States
Texas Oncology - Dallas - Worth Street /ID# 265806
Dallas, Texas, United States
Baylor Scott and White Research Institute /ID# 260853
Dallas, Texas, United States
Oncology and Hematology Associates of Southwest Virginia /ID# 265834
Roanoke, Virginia, United States
CHU Grenoble - Hopital Michallon /ID# 256627
La Tronche, Isere, France
Institut Gustave Roussy /ID# 258460
Villejuif, Val-de-Marne, France
Hôpital Avicenne /ID# 266005
Bobigny, Île-de-France Region, France
Hopital Beaujon /ID# 256551
Clichy, Île-de-France Region, France
IRCCS Istituto Clinico Humanitas /ID# 256684
Rozzano, Lombardy, Italy
IRCCS Ospedale San Raffaele /ID# 256404
Milan, Milano, Italy
P.O. Ospedale del Mare /ID# 256410
Naples, Napoli, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 265506
Rome, Roma, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 256412
Bologna, , Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 256681
Palermo, , Italy
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 256895
Roma, , Italy
Puerto Rico Medical Research Center /ID# 262362
Hato Rey, Puerto Rico, Puerto Rico
Hospital Universitario Marques de Valdecilla /ID# 255769
Santander, Cantabria, Spain
Hospital Universitario Reina Sofia /ID# 255779
Córdoba, Cordoba, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 255778
Majadahonda, Madrid, Spain
Hospital Universitario Vall d'Hebron /ID# 255771
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon /ID# 255772
Madrid, , Spain
Hospital Universitario Virgen del Rocio /ID# 255776
Seville, , Spain
Hospital Universitario Miguel Servet /ID# 255774
Zaragoza, , Spain
National Taiwan University Hospital /ID# 256168
Taipei City, Taipei, Taiwan
China Medical University Hospital /ID# 256764
Taichung, , Taiwan
Taichung Veterans General Hospital /ID# 259405
Taichung, , Taiwan
National Cheng Kung University Hospital /ID# 256766
Tainan City, , Taiwan
Taipei Veterans General Hosp /ID# 256169
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Related Links
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Other Identifiers
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2023-504600-28-00
Identifier Type: OTHER
Identifier Source: secondary_id
M24-052
Identifier Type: -
Identifier Source: org_study_id
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