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) (NCT06109272)
A Phase 2/3, Randomized Study to Evaluate the Dose Optimization, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab in Subjects With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Treatment
🩺 Plain-English Summary (8th-Grade Level)
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 combination with IV bevacizumab every 3 weeks or single dose IV tremelimumab in combination with IV durvalumab every 4 weeks. Stage 2: In arm 1, participants will receive IV infused livmoniplimab (optimized dose) in combination with IV infused budigalimab, every 3 weeks. In Arm 2 (control), participants will receive single dose IV tremelimumab in combination with IV durvalumab every 4 weeks. All participants will continue treatment until disease progression or discontinuation criteria are met, whichever occurs first. The estimated duration of this study is about 56 months. 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.
Who can join: Review the eligibility criteria below.
Location: City of Hope /ID# 261468 — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (37 Sites)
Showing the first 25 of 37 sites.
- City of Hope /ID# 261468 — Duarte, California
- City of Hope at Orange County Lennar Foundation Cancer Center /ID# 261669 — Irvine, California
- UC Irvine /ID# 255673 — Orange, California
- The University of Chicago Medical Center /ID# 255674 — Chicago, Illinois
- Alliance for Multispecialty Research LLC Kansas City Oncology /ID# 256830 — Merriam, Kansas
- Norton Cancer Institute /ID# 260775 — Louisville, Kentucky
- Henry Ford Hospital /ID# 255803 — Detroit, Michigan
- Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 256041 — Saint Louis Park, Minnesota
- Washington University-School of Medicine /ID# 255720 — St Louis, Missouri
- Texas Oncology - Abilene - Antilley Road /ID# 265820 — Abilene, Texas
- Texas Oncology - Dallas - Worth Street /ID# 265806 — Dallas, Texas
- Baylor Scott and White Research Institute /ID# 260853 — Dallas, Texas
- Oncology and Hematology Associates of Southwest Virginia /ID# 265834 — Roanoke, Virginia
- CHU Grenoble - Hopital Michallon /ID# 256627 — La Tronche, Isere
- Institut Gustave Roussy /ID# 258460 — Villejuif, Val-de-Marne
- Hôpital Avicenne /ID# 266005 — Bobigny, Île-de-France Region
- Hopital Beaujon /ID# 256551 — Clichy, Île-de-France Region
- IRCCS Istituto Clinico Humanitas /ID# 256684 — Rozzano, Lombardy
- IRCCS Ospedale San Raffaele /ID# 256404 — Milan, Milano
- P.O. Ospedale del Mare /ID# 256410 — Naples, Napoli
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 265506 — Rome, Roma
- IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 256412 — Bologna,
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 256681 — Palermo,
- Fondazione Policlinico Universitario Campus Bio-Medico /ID# 256895 — Roma,
- Puerto Rico Medical Research Center /ID# 262362 — Hato Rey, Puerto Rico
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hepatocellular Carcinoma
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- Cryoablation and Arterial Infusion of SD-101 in Combination With Durvalumab and Tremelimumab — San Diego, California
- Feasibility and Efficacy of Perioperative Nivolumab With or Without Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma (HCC) — Baltimore, Maryland
- TheraSphere With Durvalumab and Tremelimumab for HCC — San Diego, California
- Blood Salvage in Orthotopic Liver Transplantation With HCC — Toronto, Ontario
- 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) — Prescott Valley, Arizona
Explore by condition: All Hepatocellular Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.