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)
- Conditions
- Hepatocellular Carcinoma
- Registration Number
- NCT06109272
- Lead Sponsor
- AbbVie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 660
Inclusion Criteria:<br><br> - Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC)<br> with diagnosis confirmed by histology or cytology or clinically by American<br> Association for the Study of Liver Diseases criteria for participants with<br> cirrhosis.<br><br> - Barcelona Clinic Liver Cancer (BCLC) Stage B or C.<br><br> - Child-Pugh A or B7 classification (i.e., total Child-Pugh score of 5, 6, or 7).<br><br> - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.<br><br>Exclusion Criteria:<br><br> - Prior systemic therapy for HCC.<br><br> - Symptomatic, untreated, or actively progressing CNS metastases.<br><br> - History of malignancy other than HCC.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stage 1: Best Overall Response (BOR) per Investigator;Stage 2: Overall Survival (OS)
- Secondary Outcome Measures
Name Time Method