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)

NCT05822752 — Phase 2, Active not recruiting, 130 participants, AbbVie

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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

RegistryNCT05822752, acronym LIVIGNO-1
StatusActive not recruiting
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment130 (Actual)
SponsorAbbVie (Industry)
ConditionsHepatocellular Carcinoma
InterventionsBudigalimab, Livmoniplimab, Lenvatinib, Sorafenib (Drug)
Datesstart 2023-09-21, primary completion 2026-11-01 (estimated), completion 2026-11-01 (estimated), first posted 2023-04-21, last updated 2025-08-14
Locations59 sites in United States, France, Italy, Japan, South Korea, Spain, Taiwan

Related Papers Related Patents Related Grants Related Experts
All trials for Hepatocellular Carcinoma All trials of Budigalimab All trials of Livmoniplimab

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Arm 1: Lenvatinib or SorafenibActive comparatorDrug: Lenvatinib; Drug: SorafenibParticipants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period.
Arm 2: Livmoniplimab Dose A + BudigalimabExperimentalDrug: Budigalimab; Drug: LivmoniplimabParticipants will receive Livmoniplimab Dose A in combination with budigalimab, as part of an approximately 2 year treatment period.
Arm 3: Livmoniplimab Dose B + BudigalimabExperimentalDrug: Budigalimab; Drug: LivmoniplimabParticipants will receive Livmoniplimab Dose B in combination with budigalimab, as part of an approximately 2 year treatment period.
  • Budigalimab (Drug), also known as ABBV-181: Intravenous (IV) Infusion
  • Livmoniplimab (Drug), also known as ABBV-151: Intravenous (IV) Infusion
  • Lenvatinib (Drug): Oral: Capsule
  • Sorafenib (Drug): Oral: Tablet

+Outcome measures

Primary outcomes

  • Best Overall Response (BOR) per Investigator [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.

Secondary outcomes

  • Duration of response (DOR) per Investigator [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.
  • Number of Participants with Progression-free Survival (PFS) [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.
  • Overall Survival (OS) [Through Study Completion, Up to Approximately 27 Months]: OS is defined as the time from randomization until death from any cause.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (59)

FacilityCityCountryStatus
Arizona Oncology Associates, PC - NAHOA Prescott Valley /ID# 254313Prescott Valley, ArizonaUnited States
Highlands Oncology Group, PA /ID# 253158Springdale, ArkansasUnited States
University of California, Los Angeles /ID# 253292Los Angeles, CaliforniaUnited States
UC Irvine /ID# 252707Orange, CaliforniaUnited States
California Pacific Medical Center - San Francisco - Webster Street /ID# 253291San Francisco, CaliforniaUnited States
Rocky Mountain Cancer Centers - Denver Midtwon /ID# 254163Denver, ColoradoUnited States
AdventHealth Orlando /ID# 252865Orlando, FloridaUnited States
The University of Chicago Medical Center /ID# 252870Chicago, IllinoisUnited States
Hematology/Oncology Clinic /ID# 253851Baton Rouge, LouisianaUnited States
Dana-Farber Cancer Institute /ID# 252696Boston, MassachusettsUnited States
Henry Ford Hospital /ID# 253342Detroit, MichiganUnited States
Washington University-School of Medicine /ID# 252698St Louis, MissouriUnited States
NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 252708New York, New YorkUnited States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252705New York, New YorkUnited States
Messino Cancer Center - Asheville /ID# 253888Asheville, North CarolinaUnited States
University of North Carolina /ID# 252739Chapel Hill, North CarolinaUnited States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 252699Providence, Rhode IslandUnited States
Duplicate_Texas Oncology - Medical City Dallas /ID# 254164Dallas, TexasUnited States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 252770Dallas, TexasUnited States
Texas Oncology - Northeast Texas /ID# 254184Tyler, TexasUnited States
Centre Hospitalier Universitaire de Bordeaux /ID# 252749Pessac, GirondeFrance
CHU Montpellier - Hopital Saint Eloi /ID# 252760Montpellier, HeraultFrance
CHU Grenoble - Hopital Michallon /ID# 252755La Tronche, IsereFrance
CHRU Lille - Hopital Claude Huriez /ID# 252748Lille, NordFrance
AP-HP - Hopital Paul-Brousse /ID# 253646VillejuifFrance
Hopital Beaujon /ID# 252758Clichy, Île-de-France RegionFrance
Azienda Ospedaliero Universitaria Careggi /ID# 254444Florence, FirenzeItaly
IRCCS Ospedale San Raffaele /ID# 252910Milan, MilanoItaly
P.O. Ospedale del Mare /ID# 253140Naples, NapoliItaly
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 253247BolognaItaly
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 253142PalermoItaly
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 253141RomaItaly
Chiba University Hospital /ID# 255190Chiba, ChibaJapan
National Cancer Center Hospital East /ID# 253419Kashiwa-shi, ChibaJapan
Kanazawa University Hospital /ID# 254861Kanazawa, Ishikawa-kenJapan
Yokohama City University Medical Center /ID# 255790Yokohama, KanagawaJapan
Kindai University Hospital /ID# 255106Osakasayama-shi, OsakaJapan
CHA Bundang Medical Center /ID# 253054Seongnam, GyeonggidoSouth Korea
Seoul National University Bundang Hospital /ID# 253412Seongnam-si, GyeonggidoSouth Korea
Chonnam National University Hwasun Hospital /ID# 253133Hwasun-gun, JeonranamdoSouth Korea
Asan Medical Center /ID# 253044Seoul, Seoul TeugbyeolsiSouth Korea
Samsung Medical Center /ID# 253411Seoul, Seoul TeugbyeolsiSouth Korea
Hospital Universitario Marques de Valdecilla /ID# 253059Santander, CantabriaSpain
Hospital Universitario Reina Sofia /ID# 253083Córdoba, CordobaSpain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253078Majadahonda, MadridSpain
Clinica Universidad de Navarra - Pamplona /ID# 253073Pamplona, NavarreSpain
Hospital Universitario Vall d'Hebron /ID# 253063BarcelonaSpain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 254840MadridSpain
Hospital Universitario Virgen del Rocio /ID# 253074SevilleSpain
Hospital Universitario Miguel Servet /ID# 253071ZaragozaSpain
E-DA Cancer Hospital /ID# 260881Kaohsiung City, KaohsiungTaiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 253675Kaohsiung City, KaohsiungTaiwan
National Taiwan University Hospital /ID# 253449Taipei City, TaipeiTaiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 253451Kaohsiung CityTaiwan
China Medical University Hospital /ID# 253453TaichungTaiwan
Taichung Veterans General Hospital /ID# 253452TaichungTaiwan
National Cheng Kung University Hospital /ID# 253676TainanTaiwan
Taipei Veterans General Hosp /ID# 253450TaipeiTaiwan
Linkou Chang Gung Memorial Hospital /ID# 253674Taoyuan CityTaiwan

+Investigators

  • ABBVIE INC., Study director, AbbVie