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NCT06109272 · ClinicalTrials.gov registry record · Phase 2

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)

A Phase 2 study of Hepatocellular Carcinoma, sponsored by AbbVie.

Recruiting
Registry status
Phase 2
Development phase
660
Enrollment target
20
Study locations

NCT06109272 is a Phase 2 study of Hepatocellular Carcinoma that is actively recruiting participants, run by AbbVie. The registered enrollment target is 660 participants, above the 253-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (161% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT06109272, a Phase 2 study of Hepatocellular Carcinoma, is actively recruiting participants, sponsored by AbbVie.

RECRUITING
Registry status
Phase 2
Development phase
660 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 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, whichev

Conditions Studied

Hepatocellular Carcinoma

Interventions

  • DRUG Bevacizumab
  • DRUG Atezolizumab
  • DRUG Budigalimab
  • DRUG Durvalumab
  • DRUG Livmoniplimab

Study Locations (20)

California

  • City of Hope /ID# 261468 - Duarte
  • City of Hope at Orange County Lennar Foundation Cancer Center /ID# 261669 - Irvine
  • UC Irvine /ID# 255673 - Orange

Texas

  • Texas Oncology - Abilene - Antilley Road /ID# 265820 - Abilene
  • Texas Oncology - Dallas - Worth Street /ID# 265806 - Dallas
  • Baylor Scott and White Research Institute /ID# 260853 - Dallas

Île-de-France Region

  • Hôpital Avicenne /ID# 266005 - Bobigny
  • Hopital Beaujon /ID# 256551 - Clichy

Illinois

  • The University of Chicago Medical Center /ID# 255674 - Chicago

Kansas

  • Alliance for Multispecialty Research LLC Kansas City Oncology /ID# 256830 - Merriam

Kentucky

  • Norton Cancer Institute /ID# 260775 - Louisville

Michigan

  • Henry Ford Hospital /ID# 255803 - Detroit

Minnesota

  • Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 256041 - Saint Louis Park

Trial Details

FieldValue
Enrollment Target 660 participants
Start Date 2024-01-11
Est. Completion 2030-09
Phase Phase 2

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06109272

The ClinicalTrials.gov registry entry for NCT06109272 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 660 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 253-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (161% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Bevacizumab is the first listed.

NCT06109272 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Texas, Île-de-France Region.

Frequently Asked Questions

What is clinical trial NCT06109272 about?

NCT06109272 is a clinical study titled "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)". 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 NCT06109272?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 660 participants. The study started on 2024-01-11. Estimated completion is 2030-09.

What conditions does trial NCT06109272 study?

This clinical trial studies the following conditions: Hepatocellular Carcinoma.

What interventions are being tested in trial NCT06109272?

The interventions under investigation include: Bevacizumab (DRUG), Atezolizumab (DRUG), Budigalimab (DRUG), Durvalumab (DRUG), Livmoniplimab (DRUG).

Who is sponsoring clinical trial NCT06109272?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06109272 being conducted?

This trial has 20 study locations across California, Illinois, Kansas, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.