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)
Public ClinicalTrials.gov record NCT06109272. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06109272
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 89 participants
Conditions and interventions
Conditions
Interventions
- Livmoniplimab Drug
- Budigalimab Drug
- Durvalumab Drug
- Atezolizumab Drug
- Bevacizumab Drug
- Tremelimumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 11, 2024 (Actual)
- Primary completion
- Jan 2027 (Estimated)
- Completion
- Jan 2027 (Estimated)
- Last update posted
- Sep 22, 2026
2024 – 2027
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope /ID# 261468 | Duarte | California | 91010 | — |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 261669 | Irvine | California | 92618 | — |
| UC Irvine /ID# 255673 | Orange | California | 92868 | — |
| The University of Chicago Medical Center /ID# 255674 | Chicago | Illinois | 60637-1443 | — |
| Alliance for Multispecialty Research LLC Kansas City Oncology /ID# 256830 | Merriam | Kansas | 66204 | — |
| Norton Cancer Institute /ID# 260775 | Louisville | Kentucky | 40217-1395 | — |
| Henry Ford Hospital - Detroit /ID# 255803 | Detroit | Michigan | 48202 | — |
| Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 256041 | Saint Louis Park | Minnesota | 55416 | — |
| Washington University-School of Medicine /ID# 255720 | St Louis | Missouri | 63110 | — |
| Texas Oncology - Abilene - Antilley Road /ID# 265820 | Abilene | Texas | 79606 | — |
| Texas Oncology - Dallas - Worth Street /ID# 265806 | Dallas | Texas | 75246 | — |
| Baylor Scott and White Research Institute /ID# 260853 | Dallas | Texas | 76508-0001 | — |
| Oncology and Hematology Associates of Southwest Virginia /ID# 265834 | Roanoke | Virginia | 98684 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06109272, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 22, 2026 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06109272 live on ClinicalTrials.gov.