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) (NCT05822752)
A Phase 2, Randomized Study to Evaluate the Optimized Dose, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab for Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Patients Who Have Progressed After an Immune Checkpoint Inhibitor Containing Regimen in First-Line HCC
🩺 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 3 treatment arms in this study 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), lenvatinib, or sorafenib. Approximately 120 adult participants will be enrolled in the study across 60 sites worldwide. In arm 1 (control), participants will receive the investigator's choice: lenvatinib as an oral capsule or sorafenib as an oral tablet, once daily. In arm 2, participants will receive intravenously (IV) infused livmoniplimab (dose A) in combination with IV infused budigalimab, every 3 weeks. In arm 3, participants will receive intravenously (IV) infused livmoniplimab (dose B) in combination with IV infused budigalimab, every 3 weeks. The estimated duration of the study is up to 2 years 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: Arizona Oncology Associates, PC - NAHOA Prescott Valley /ID# 254313 — Prescott Valley, Arizona
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 (59 Sites)
Showing the first 25 of 59 sites.
- Arizona Oncology Associates, PC - NAHOA Prescott Valley /ID# 254313 — Prescott Valley, Arizona
- Highlands Oncology Group, PA /ID# 253158 — Springdale, Arkansas
- University of California, Los Angeles /ID# 253292 — Los Angeles, California
- UC Irvine /ID# 252707 — Orange, California
- California Pacific Medical Center - San Francisco - Webster Street /ID# 253291 — San Francisco, California
- Rocky Mountain Cancer Centers - Denver Midtwon /ID# 254163 — Denver, Colorado
- AdventHealth Orlando /ID# 252865 — Orlando, Florida
- The University of Chicago Medical Center /ID# 252870 — Chicago, Illinois
- Hematology/Oncology Clinic /ID# 253851 — Baton Rouge, Louisiana
- Dana-Farber Cancer Institute /ID# 252696 — Boston, Massachusetts
- Henry Ford Hospital /ID# 253342 — Detroit, Michigan
- Washington University-School of Medicine /ID# 252698 — St Louis, Missouri
- NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 252708 — New York, New York
- Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252705 — New York, New York
- Messino Cancer Center - Asheville /ID# 253888 — Asheville, North Carolina
- University of North Carolina /ID# 252739 — Chapel Hill, North Carolina
- Lifespan Cancer Institute at Rhode Island Hospital /ID# 252699 — Providence, Rhode Island
- Duplicate_Texas Oncology - Medical City Dallas /ID# 254164 — Dallas, Texas
- Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 252770 — Dallas, Texas
- Texas Oncology - Northeast Texas /ID# 254184 — Tyler, Texas
- Centre Hospitalier Universitaire de Bordeaux /ID# 252749 — Pessac, Gironde
- CHU Montpellier - Hopital Saint Eloi /ID# 252760 — Montpellier, Herault
- CHU Grenoble - Hopital Michallon /ID# 252755 — La Tronche, Isere
- CHRU Lille - Hopital Claude Huriez /ID# 252748 — Lille, Nord
- AP-HP - Hopital Paul-Brousse /ID# 253646 — Villejuif,
💰 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.
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Explore by condition: All Hepatocellular Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.