Study of Livmoniplimab and Budigalimab for Liver Cancer (HCC)

This study is looking at new ways to treat hepatocellular carcinoma (HCC), a type of liver cancer. Researchers are testing an investigational drug called livmoniplimab in combination with another investigational drug, budigalimab. They want to find the best dose, understand any side effects, and see how well this combination works to shrink tumors or slow the cancer's growth. You might receive livmoniplimab plus budigalimab, or other approved drug combinations like atezolizumab with bevacizumab, or tremelimumab with durvalumab. The study is open to adults aged 18 and older who have advanced or unresectable HCC. The main goals are to see how many participants respond to treatment and how long they live. This study is currently recruiting 660 participants.

Study design
This interventional study has two stages and involves 660 participants. In Stage 1, participants will be randomly assigned to one of three treatment groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 56 months (about 4 years and 8 months) to assess treatment response and overall survival.

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NCT06109272

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)

Recruiting
PHASE2Ages 18+InterventionalTreatment
AbbVie
~660 participants
Updated 2025-08-15 on ClinicalTrials.gov
What's tested:LivmoniplimabBudigalimabDurvalumabAtezolizumabBevacizumabTremelimumab

At a glance

Recruiting sites
34 of 37 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stage 1: Best Overall Response (BOR) per Investigator
Measured over Through Study Completion, Up to Approximately 56 Months
+1 more outcome measured
Hepatocellular Carcinoma

NCT06109272

Where you'd take part

This study runs at 37 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baylor Scott and White Research Institute /ID# 260853

    Dallas, Texasstudy coordinator listed

    Recruiting

  • Henry Ford Hospital /ID# 255803

    Detroit, Michiganstudy coordinator listed

    Recruiting

  • Hospital Universitario Miguel Servet /ID# 255774

    Zaragoza, Spainstudy coordinator listed

    Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 256681

    Palermo, Italyno site contact published

    Recruiting

  • CHU Grenoble - Hopital Michallon /ID# 256627

    La Tronche, Isere, Franceno site contact published

    Recruiting

  • City of Hope /ID# 261468

    Duarte, Californiano site contact published

    Recruiting

  • City of Hope at Orange County Lennar Foundation Cancer Center /ID# 261669

    Irvine, Californiano site contact published

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 265506

    Rome, Roma, Italyno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

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Eligibility criteria

Inclusion

Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology or cytology or clinically by American Association for the Study of Liver Diseases criteria for participants with cirrhosis.
Barcelona Clinic Liver Cancer (BCLC) Stage B or C.
Child-Pugh A or B7 classification (i.e., total Child-Pugh score of 5, 6, or 7).
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

Exclusion

Prior systemic therapy for HCC.
Symptomatic, untreated, or actively progressing CNS metastases.
History of malignancy other than HCC.
  • Stage 1: Best Overall Response (BOR) per InvestigatorThrough Study Completion, Up to Approximately 56 Months

    BOR is defined as a participant 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.

  • Stage 2: Overall Survival (OS)Through Study Completion, Up to Approximately 56 Months

    OS is defined as the time from randomization until death from any cause