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Livmoniplimab plus budigalimab for adults with hepatocellular carcinoma

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

Phase2; Phase3 Interventional AbbVie · NCT06109272

We will test whether giving livmoniplimab together with budigalimab is safe and can reduce disease activity in adults with advanced or unresectable hepatocellular carcinoma.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment660 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionslivmoniplimab, budigalimab, atezolizumab, bevacizumab, tremelimumab, durvalumab
Locations37 sites (Duarte, California and 36 other locations)
Trial IDNCT06109272 on ClinicalTrials.gov

What this trial studies

This interventional Phase 2/3 program uses a two-stage randomized design to find an optimized dose and measure safety and effectiveness of livmoniplimab combined with budigalimab. In Stage 1 participants are randomized 1:1:1 to one of three arms (two different livmoniplimab doses plus budigalimab, atezolizumab plus bevacizumab, or tremelimumab plus durvalumab) to select a preferred dose and gather safety data. In Stage 2 participants are randomized 1:1 to receive the chosen livmoniplimab dose with budigalimab or tremelimumab plus durvalumab for comparative efficacy and longer-term safety. Regular IV infusions and scheduled tumor and safety assessments will be used to measure adverse events and changes in disease activity.

Who should consider this trial

Good fit: Adults with locally advanced, unresectable, or metastatic hepatocellular carcinoma who have not had prior systemic therapy and who are Child-Pugh A or B7 with ECOG 0–1 are appropriate candidates.

Not a fit: People who have already had systemic therapy for HCC, have symptomatic or untreated brain metastases, or a recent other malignancy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could slow tumor growth or improve outcomes for people with advanced HCC.

How similar studies have performed: Other immune checkpoint combinations such as atezolizumab plus bevacizumab have shown benefit in HCC, but the livmoniplimab plus budigalimab combination is newer and less tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* Prior systemic therapy for HCC.
* Symptomatic, untreated, or actively progressing CNS metastases.
* History of malignancy other than HCC.

Where this trial is running

Duarte, California and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hepatocellular CarcinomaLivmoniplimabABBV-151budigalimabABBV-181
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.