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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 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Budigalimab
- DRUG Lenvatinib
- DRUG Sorafenib
- DRUG Livmoniplimab
Study Locations (20)
California
- University of California, Los Angeles /ID# 253292 — Los Angeles
- UC Irvine /ID# 252707 — Orange
- California Pacific Medical Center - San Francisco - Webster Street /ID# 253291 — San Francisco
Texas
- Duplicate_Texas Oncology - Medical City Dallas /ID# 254164 — Dallas
- Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 252770 — Dallas
- Texas Oncology - Northeast Texas /ID# 254184 — Tyler
New York
- NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 252708 — New York
- Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252705 — New York
North Carolina
- Messino Cancer Center - Asheville /ID# 253888 — Asheville
- University of North Carolina /ID# 252739 — Chapel Hill
Arizona
- Arizona Oncology Associates, PC - NAHOA Prescott Valley /ID# 254313 — Prescott Valley
Arkansas
- Highlands Oncology Group, PA /ID# 253158 — Springdale
Colorado
- Rocky Mountain Cancer Centers - Denver Midtwon /ID# 254163 — Denver
Florida
- AdventHealth Orlando /ID# 252865 — Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2023-09-21 |
| Est. Completion | 2026-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05822752
The ClinicalTrials.gov registry entry for NCT05822752 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 4 interventions — of which Budigalimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05822752 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Texas, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05822752 about?
NCT05822752 is a clinical study titled "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)". 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 ...
What is the current status of trial NCT05822752?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2023-09-21. Estimated completion is 2026-11.
What conditions does trial NCT05822752 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05822752?
The interventions under investigation include: Budigalimab (DRUG), Lenvatinib (DRUG), Sorafenib (DRUG), Livmoniplimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05822752?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05822752 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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