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)

Part of paid clinical trials in Duarte, California.

Sponsor
AbbVie
Study ID
NCT06109272
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 11, 2024
Status verified
Aug 2025
Primary completion
Sep 30, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
660 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Active Comparator: 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.
  • Active Comparator: 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.
  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Stage 1: Best Overall Response (BOR) per Investigator [ Time Frame: Through Study Completion, Up to Approximately 56 Months ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
City of Hope /ID# 261468DuarteCalifornia91010-
City of Hope at Orange County Lennar Foundation Cancer Center /ID# 261669IrvineCalifornia92618-
UC Irvine /ID# 255673OrangeCalifornia92868-
The University of Chicago Medical Center /ID# 255674ChicagoIllinois60637-1443-
Alliance for Multispecialty Research LLC Kansas City Oncology /ID# 256830MerriamKansas66204-
Norton Cancer Institute /ID# 260775LouisvilleKentucky40217-1395-
Henry Ford Hospital /ID# 255803DetroitMichigan48202
Site Coordinator
(313) 916-8423
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 256041Saint Louis ParkMinnesota55416-
Washington University-School of Medicine /ID# 255720St LouisMissouri63110-
Texas Oncology - Abilene - Antilley Road /ID# 265820AbileneTexas79606-
Baylor Scott and White Research Institute /ID# 260853DallasTexas76508-0001
Site Coordinator
254-724-1054
Texas Oncology - Dallas - Worth Street /ID# 265806DallasTexas75246-
Oncology and Hematology Associates of Southwest Virginia /ID# 265834RoanokeVirginia98684-

Find similar trials in Duarte, CA

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By specialty
OncologyGI oncologyHepatology
By research site
City of Hope· Duarte, CACity of Hope at Orange County Lennar Foundation Cancer Center· Irvine, CAUC Irvine· Orange, CAThe University of Chicago Medical Center· Chicago, ILAlliance for Multispecialty Research LLC Kansas City Oncology· Merriam, KSNorton Cancer Institute· Louisville, KY

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