Status:
RECRUITING
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)
Lead Sponsor:
AbbVie
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- Prior systemic therapy for HCC.
- Symptomatic, untreated, or actively progressing CNS metastases.
- History of malignancy other than HCC.
Key Trial Info
Start Date :
January 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT06109272
Start Date
January 11 2024
End Date
September 1 2030
Last Update
August 15 2025
Active Locations (37)
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1
City of Hope /ID# 261468
Duarte, California, United States, 91010
2
City of Hope at Orange County Lennar Foundation Cancer Center /ID# 261669
Irvine, California, United States, 92618
3
UC Irvine /ID# 255673
Orange, California, United States, 92868
4
The University of Chicago Medical Center /ID# 255674
Chicago, Illinois, United States, 60637-1443