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)

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified July 2025 by AbbVie
Sponsor
AbbVie
Information Provided by (Responsible Party)
AbbVie
Clinicaltrials.gov Identifier
NCT06109272
Other Study ID Numbers:
M24-052
First Submitted
October 25, 2023
First Posted
October 30, 2023
Last Update Posted
August 14, 2025
Last Verified
July 2025

ClinicalTrials.gov processed this data on August 2025Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Hepatocellular Carcinoma
Drug: LivmoniplimabDrug: LivmoniplimabDrug: AtezolizumabDrug: DurvalumabDrug: LivmoniplimabDrug: Durvalumab

Study Design

Study TypeInterventional
Actual Enrollment660 participants
Design AllocationRandomized
Interventional ModelSequential Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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
Study Start DateJanuary 10, 2024
Actual Primary Completion Date4yrs 3mos from now
Actual Study Completion Date4yrs 3mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
Drug: Livmoniplimab
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.
Drug: Livmoniplimab
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.
Drug: Atezolizumab
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.
Drug: Durvalumab
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.
Drug: Livmoniplimab
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.
Drug: Durvalumab
Intravenous (IV) Solution

Outcome Measures

Primary Outcome Measures
  1. 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.
  2. Stage 2: Overall Survival (OS)
    OS is defined as the time from randomization until death from any cause
Secondary Outcome Measures
  1. Stage 1: Number of Participants with Progression-Free Survival (PFS)
    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.
  2. Stage 1: Duration of Response (DOR) per Investigator
    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.
  3. Stage 1: Overall Survival (OS)
    OS is defined as the time from randomization until death from any cause.
  4. Stage 1: Number of Participants with Adverse Events (AEs)
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
  5. Stage 1: Maximum Plasma Concentration (Cmax) of Livmoniplimab and Budigalimab
    Cmax of livmoniplimab and budigalimab.
  6. Stage 1: Time to Cmax (Tmax) of Livmoniplimab and Budigalimab
    Tmax of livmoniplimab and budigalimab.
  7. Stage 1: Area Under the Serum Concentration Versus Time Curve (AUC) of Livmoniplimab and Budigalimab
    AUC of livmoniplimab and budigalimab.
  8. Stage 2: Number of Participants with Progression-Free Survival (PFS)
    PFS is defined as the time from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined blinded independent central review (BICR) or death from any cause, whichever occurs first.
  9. Stage 2: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) per BICR
    BOR is defined as a participant achieving confirmed CR/PR per RECIST 1.1 as determined by BICR at any time prior to subsequent anticancer therapy.
  10. Change from Baseline in the Pain Domain of the European Organization for Research Treatment of Cancer Quality of Life Questionnaire Hepatocellular Carcinoma 18-Question Module (EORTC QLQ-HCC18)
    The EORTC QLQ-HCC18 is an 18-item scale that measures hepatocellular carcinoma (HCC)-specific symptoms and health-related quality of life (HRQoL). The Pain Domain contains 2 items where scores are based on a 4-point Likert scale (with 1 = 'not at all' to 4 = 'very much'); scaled scores for each domain ranged from 0-100 with a higher score indicating worse symptoms.
  11. Change from Baseline in the Fatigue Domain of the EORTC QLQ-HCC18
    The EORTC QLQ-HCC18 is an 18-item scale that measures HCC-specific symptoms and HRQoL. The Fatigue Domain contains 3 items where scores are based on a 4-point Likert scale (with 1 = 'not at all' to 4 = 'very much'); scaled scores for each domain ranged from 0-100 with a higher score indicating worse symptoms.
  12. Change from Baseline in Physical Function (PF) Domain of the European Organization for Research Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)
    The EORTC QLQ-C30 is an 30-item patient-reported questionnaire that measures symptoms and HRQoL. The PF Domain is a functional scale where participants rate items on a 4-point scale (with 1 = 'not at all' to 4 = 'very much'). A change of 5 to 10 points is considered a small change and the lower bound (5) will be used to define the minimum important difference. A change of \>= 10 to \< 20 points is considered a moderate change.
  13. Change from Baseline in Global Health Status (GHS)/Quality of Life (QoL) Domain as Measured by the GHS/QoL Domain of the EORTC QLQ-C30
    The EORTC QLQ-C30 is an 30-item patient-reported questionnaire that measures symptoms and HRQoL. The GHS/QoL Domain is a scale where participants rate items on a 4-point scale (with 1 = 'not at all' to 4 = 'very much'). A change of 5 to 10 points is considered a small change and the lower bound (5) will be used to define the minimum important difference. A change of ≥ 10 to \< 20 points is considered a moderate change.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
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.
Exclusion Criteria
Prior systemic therapy for HCC.
Symptomatic, untreated, or actively progressing CNS metastases.
History of malignancy other than HCC.

Contacts and Locations

Sponsors and CollaboratorsAbbVie
Locations
City of Hope /ID# 261468 | Duarte California, United States, 91010City of Hope at Orange County Lennar Foundation Cancer Center /ID# 261669 | Irvine California, United States, 92618UC Irvine /ID# 255673 | Orange California, United States, 92868The University of Chicago Medical Center /ID# 255674 | Chicago Illinois, United States, 60637-1443Alliance for Multispecialty Research LLC Kansas City Oncology /ID# 256830 | Merriam Kansas, United States, 66204Norton Cancer Institute /ID# 260775 | Louisville Kentucky, United States, 40217-1395Henry Ford Hospital /ID# 255803 | Detroit Michigan, United States, 48202Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 256041 | Saint Louis Park Minnesota, United States, 55416Washington University-School of Medicine /ID# 255720 | St Louis Missouri, United States, 63110Texas Oncology - Abilene - Antilley Road /ID# 265820 | Abilene Texas, United States, 79606Texas Oncology - Dallas - Worth Street /ID# 265806 | Dallas Texas, United States, 75246Baylor Scott and White Research Institute /ID# 260853 | Dallas Texas, United States, 76508-0001Oncology and Hematology Associates of Southwest Virginia /ID# 265834 | Roanoke Virginia, United States, 98684CHU Grenoble - Hopital Michallon /ID# 256627 | La Tronche Isere, France, 38700Institut Gustave Roussy /ID# 258460 | Villejuif Val-de-Marne, France, 94805Hôpital Avicenne /ID# 266005 | Bobigny Île-de-France Region, France, 93000Hopital Beaujon /ID# 256551 | Clichy Île-de-France Region, France, 92110IRCCS Istituto Clinico Humanitas /ID# 256684 | Rozzano Lombardy, Italy, 20089IRCCS Ospedale San Raffaele /ID# 256404 | Milan Milano, Italy, 20132P.O. Ospedale del Mare /ID# 256410 | Naples Napoli, Italy, 80147Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 265506 | Rome Roma, Italy, 00168IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 256412 | Bologna , Italy, 40138Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 256681 | Palermo , Italy, 90127Fondazione Policlinico Universitario Campus Bio-Medico /ID# 256895 | Roma , Italy, 00128Puerto Rico Medical Research Center /ID# 262362 | Hato Rey Puerto Rico, Puerto Rico, 00917Hospital Universitario Marques de Valdecilla /ID# 255769 | Santander Cantabria, Spain, 39008Hospital Universitario Reina Sofia /ID# 255779 | Córdoba Cordoba, Spain, 14004Hospital Universitario Puerta de Hierro - Majadahonda /ID# 255778 | Majadahonda Madrid, Spain, 28222Hospital Universitario Vall d'Hebron /ID# 255771 | Barcelona , Spain, 08035Hospital General Universitario Gregorio Maranon /ID# 255772 | Madrid , Spain, 28007Hospital Universitario Virgen del Rocio /ID# 255776 | Seville , Spain, 41013Hospital Universitario Miguel Servet /ID# 255774 | Zaragoza , Spain, 50009National Taiwan University Hospital /ID# 256168 | Taipei City Taipei, Taiwan, 100China Medical University Hospital /ID# 256764 | Taichung , Taiwan, 40447Taichung Veterans General Hospital /ID# 259405 | Taichung , Taiwan, 40705National Cheng Kung University Hospital /ID# 256766 | Tainan , Taiwan, 704Taipei Veterans General Hosp /ID# 256169 | Taipei , Taiwan, 11217
Investigators
Study Director: ABBVIE INC., AbbVie