Study on the Effects and Safety of Livmoniplimab and Budigalimab for Liver Cancer
Sponsor: AbbVie
ClinicalTrials ID:NCT06109272
This clinical trial is testing a new treatment using two investigational drugs, Livmoniplimab and Budigalimab, for adults with advanced liver cancer. The study aims to find the best dose, check for side effects, and see how well the treatment works.
Patient Parameters
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Program Overview
Liver cancer, specifically hepatocellular carcinoma (HCC), is a common and serious type of cancer. This study is exploring a new treatment using Livmoniplimab and Budigalimab to see if it can help people with advanced liver cancer. The study has two stages. In the first stage, participants will be randomly assigned to one of three groups to receive different treatments. In the second stage, participants will be assigned to one of two groups. The study will involve about 660 adults from around the world and will last approximately 56 months. Participants will receive their treatments through an IV every few weeks and will continue until the cancer progresses or they need to stop for other reasons. Regular hospital or clinic visits will be required for check-ups, tests, and scans.
Eligibility Criteria
Inclusion Criteria
- Have advanced liver cancer that cannot be removed by surgery, confirmed by medical tests.
- Be in Stage B or C of liver cancer according to the Barcelona Clinic Liver Cancer (BCLC) staging system.
- Have a Child-Pugh score of 5, 6, or 7, indicating liver function.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Have received previous treatment for liver cancer.
- Have untreated or worsening cancer that has spread to the brain.
- Have a history of other types of cancer besides liver cancer.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope /ID# 261468 | 91010 | Duarte | California |
| City of Hope at Orange County Lennar Foundation Cancer Center /ID# 261669 | 92618 | Irvine | California |
| UC Irvine /ID# 255673 | 92868 | Orange | California |
| The University of Chicago Medical Center /ID# 255674 | 60637-1443 | Chicago | Illinois |
| Alliance for Multispecialty Research LLC Kansas City Oncology /ID# 256830 | 66204 | Merriam | Kansas |
| Norton Cancer Institute /ID# 260775 | 40217-1395 | Louisville | Kentucky |
| Henry Ford Hospital /ID# 255803 | 48202 | Detroit | Michigan |
| Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 256041 | 55416 | Saint Louis Park | Minnesota |
| Washington University-School of Medicine /ID# 255720 | 63110 | Saint Louis | Missouri |
| Texas Oncology - Abilene - Antilley Road /ID# 265820 | 79606 | Abilene | Texas |
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