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)
NCT ID: NCT05822752
Last Updated: 2025-08-14
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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ACTIVE_NOT_RECRUITING
PHASE2
130 participants
INTERVENTIONAL
2023-09-21
2026-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: Lenvatinib or Sorafenib
Participants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period.
Lenvatinib
Oral: Capsule
Sorafenib
Oral: Tablet
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.
Budigalimab
Intravenous (IV) Infusion
Livmoniplimab
Intravenous (IV) Infusion
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.
Budigalimab
Intravenous (IV) Infusion
Livmoniplimab
Intravenous (IV) Infusion
Interventions
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Budigalimab
Intravenous (IV) Infusion
Livmoniplimab
Intravenous (IV) Infusion
Lenvatinib
Oral: Capsule
Sorafenib
Oral: Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
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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Arizona Oncology Associates, PC - NAHOA Prescott Valley /ID# 254313
Prescott Valley, Arizona, United States
Highlands Oncology Group, PA /ID# 253158
Springdale, Arkansas, United States
University of California, Los Angeles /ID# 253292
Los Angeles, California, United States
UC Irvine /ID# 252707
Orange, California, United States
California Pacific Medical Center - San Francisco - Webster Street /ID# 253291
San Francisco, California, United States
Rocky Mountain Cancer Centers - Denver Midtwon /ID# 254163
Denver, Colorado, United States
AdventHealth Orlando /ID# 252865
Orlando, Florida, United States
The University of Chicago Medical Center /ID# 252870
Chicago, Illinois, United States
Hematology/Oncology Clinic /ID# 253851
Baton Rouge, Louisiana, United States
Dana-Farber Cancer Institute /ID# 252696
Boston, Massachusetts, United States
Henry Ford Hospital /ID# 253342
Detroit, Michigan, United States
Washington University-School of Medicine /ID# 252698
St Louis, Missouri, United States
NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 252708
New York, New York, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252705
New York, New York, United States
Messino Cancer Center - Asheville /ID# 253888
Asheville, North Carolina, United States
University of North Carolina /ID# 252739
Chapel Hill, North Carolina, United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 252699
Providence, Rhode Island, United States
Duplicate_Texas Oncology - Medical City Dallas /ID# 254164
Dallas, Texas, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 252770
Dallas, Texas, United States
Texas Oncology - Northeast Texas /ID# 254184
Tyler, Texas, United States
Centre Hospitalier Universitaire de Bordeaux /ID# 252749
Pessac, Gironde, France
CHU Montpellier - Hopital Saint Eloi /ID# 252760
Montpellier, Herault, France
CHU Grenoble - Hopital Michallon /ID# 252755
La Tronche, Isere, France
CHRU Lille - Hopital Claude Huriez /ID# 252748
Lille, Nord, France
AP-HP - Hopital Paul-Brousse /ID# 253646
Villejuif, , France
Hopital Beaujon /ID# 252758
Clichy, Île-de-France Region, France
Azienda Ospedaliero Universitaria Careggi /ID# 254444
Florence, Firenze, Italy
IRCCS Ospedale San Raffaele /ID# 252910
Milan, Milano, Italy
P.O. Ospedale del Mare /ID# 253140
Naples, Napoli, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 253247
Bologna, , Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 253142
Palermo, , Italy
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 253141
Roma, , Italy
Chiba University Hospital /ID# 255190
Chiba, Chiba, Japan
National Cancer Center Hospital East /ID# 253419
Kashiwa-shi, Chiba, Japan
Kanazawa University Hospital /ID# 254861
Kanazawa, Ishikawa-ken, Japan
Yokohama City University Medical Center /ID# 255790
Yokohama, Kanagawa, Japan
Kindai University Hospital /ID# 255106
Osakasayama-shi, Osaka, Japan
CHA Bundang Medical Center /ID# 253054
Seongnam, Gyeonggido, South Korea
Seoul National University Bundang Hospital /ID# 253412
Seongnam-si, Gyeonggido, South Korea
Chonnam National University Hwasun Hospital /ID# 253133
Hwasun-gun, Jeonranamdo, South Korea
Asan Medical Center /ID# 253044
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 253411
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Universitario Marques de Valdecilla /ID# 253059
Santander, Cantabria, Spain
Hospital Universitario Reina Sofia /ID# 253083
Córdoba, Cordoba, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253078
Majadahonda, Madrid, Spain
Clinica Universidad de Navarra - Pamplona /ID# 253073
Pamplona, Navarre, Spain
Hospital Universitario Vall d'Hebron /ID# 253063
Barcelona, , Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 254840
Madrid, , Spain
Hospital Universitario Virgen del Rocio /ID# 253074
Seville, , Spain
Hospital Universitario Miguel Servet /ID# 253071
Zaragoza, , Spain
E-DA Cancer Hospital /ID# 260881
Kaohsiung City, Kaohsiung, Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 253675
Kaohsiung City, Kaohsiung, Taiwan
National Taiwan University Hospital /ID# 253449
Taipei City, Taipei, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 253451
Kaohsiung City, , Taiwan
China Medical University Hospital /ID# 253453
Taichung, , Taiwan
Taichung Veterans General Hospital /ID# 253452
Taichung, , Taiwan
National Cheng Kung University Hospital /ID# 253676
Tainan City, , Taiwan
Taipei Veterans General Hosp /ID# 253450
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 253674
Taoyuan, , Taiwan
Countries
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Related Links
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Related Info.
Other Identifiers
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2022-502948-13-00
Identifier Type: OTHER
Identifier Source: secondary_id
M24-147
Identifier Type: -
Identifier Source: org_study_id
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