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)

Study Identifier
M24-147
CT.gov Identifier
NCT05822752
EudraCT Identifier
Not available
EUCTIS ID
2022-502948-13-00
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Liver Cancer
    • Study Drug
  • Budigalimab
  • Livmoniplimab
  • Lenvatinib
  • Sorafenib
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Arizona Oncology Associates, PC - NAHOA Prescott Valley /ID# 254313
    Prescott Valley, Arizona, United States, 86314
    Status
    Not applicable
    Location
    Highlands Oncology Group, PA /ID# 253158
    Springdale, Arkansas, United States, 72762
    Status
    Not applicable
    Location
    University of California, Los Angeles /ID# 253292
    Los Angeles, California, United States, 90095
    Status
    Not applicable
    Location
    UC Irvine /ID# 252707
    Orange, California, United States, 92868
    Status
    Not applicable
    Location
    California Pacific Medical Center - San Francisco - Webster Street /ID# 253291
    San Francisco, California, United States, 94115
    Status
    Not applicable
    Location
    Rocky Mountain Cancer Centers - Denver Midtwon /ID# 254163
    Denver, Colorado, United States, 80218
    Status
    Not applicable
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