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NCT05822752 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of Hepatocellular Carcinoma, sponsored by AbbVie.
- Active
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
- 20
- Study locations
NCT05822752: Active Phase 2 study of Hepatocellular Carcinoma, sponsored by AbbVie.
NCT05822752 is a Phase 2 study of Hepatocellular Carcinoma that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 130 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05822752, a Phase 2 study of Hepatocellular Carcinoma, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
BOR is defined as a subject achieving confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by investigators at any time prior to subsequent anticancer therapy.
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 |
What the registry record for NCT05822752 still lists
NCT05822752 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (49% lower).
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.
NCT05822752 names 20 study sites across 14 states, led by California, Texas, New York.
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.
What interventions are being tested in trial NCT05822752?
The interventions under investigation include: Budigalimab (DRUG), Lenvatinib (DRUG), Sorafenib (DRUG), Livmoniplimab (DRUG).
Who is sponsoring clinical trial NCT05822752?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05822752's enrollment target sits among peer trials
130 48th of 145 higher than 98 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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