Condition: Hepatocellular Carcinoma · Sponsor: AbbVie
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 combin…
This description comes directly from the study's public registry record.
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| City of Hope /ID# 261468 | Duarte, California, United States | Recruiting |
| City of Hope at Orange County Lennar Foundation Cancer Center /ID# 261669 | Irvine, California, United States | Recruiting |
| UC Irvine /ID# 255673 | Orange, California, United States | Recruiting |
| The University of Chicago Medical Center /ID# 255674 | Chicago, Illinois, United States | Recruiting |
| Alliance for Multispecialty Research LLC Kansas City Oncology /ID# 256830 | Merriam, Kansas, United States | Completed |
| Norton Cancer Institute /ID# 260775 | Louisville, Kentucky, United States | Recruiting |
| Henry Ford Hospital /ID# 255803 | Detroit, Michigan, United States | Recruiting |
| Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 256041 | Saint Louis Park, Minnesota, United States | Recruiting |
| Washington University-School of Medicine /ID# 255720 | St Louis, Missouri, United States | Recruiting |
| Texas Oncology - Abilene - Antilley Road /ID# 265820 | Abilene, Texas, United States | Recruiting |
| Texas Oncology - Dallas - Worth Street /ID# 265806 | Dallas, Texas, United States | Recruiting |
| Baylor Scott and White Research Institute /ID# 260853 | Dallas, Texas, United States | Recruiting |
+ 25 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06109272