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NCT Number: NCT05822752

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 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Universitaire de Bordeaux /ID# 252749, Pessac, Gironde, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child-Pugh A classification.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  • Received an immune checkpoint inhibitor in first-line (1L) hepatocellular carcinoma (HCC) treatment regimen.
  • Adequate hematologic and end-organ function.
  • Tissue biopsy at screening.
  • Disease that is not amenable to surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies.

Exclusion criteria

  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
  • Prior treatment with an approved tyrosine kinase inhibitor (for example sorafenib or Lenvatinib) in 1L HCC treatment regimen.
  • History of malignancy other than hepatocellular carcinoma (HCC) within 5 years prior to screening.
  • Hepatic encephalopathy or requirement for medications to prevent or control encephalopathy.
  • Moderate or severe ascites requiring recurrent non-pharmacologic intervention to maintain symptomatic control.
  • Coinfection with active HBV infection and active HCV infection.
  • Prior history of grade 3 or higher immune-mediated adverse event or discontinuation due to immune-mediated adverse events.
  • Prior history of recurrent grade 2 or higher interstitial lung disease/pneumonitis.

Treatment and study plan

Budigalimab

Drug

Intravenous (IV) Infusion

Other names: ABBV-181

Livmoniplimab

Drug

Intravenous (IV) Infusion

Other names: ABBV-151

Lenvatinib

Drug

Oral: Capsule

Sorafenib

Drug

Oral: Tablet

Primary outcomes

  1. Best Overall Response (BOR) per Investigator

    Time frame: Through Study Completion, Up to Approximately 27 Months

    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.

Secondary outcomes

  1. Duration of response (DOR) per Investigator

    Time frame: Through Study Completion, Up to Approximately 27 Months

    DOR is defined as the time from first confirmed CR or PR until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.

  2. Number of Participants with Progression-free Survival (PFS)

    Time frame: Through Study Completion, Up to Approximately 27 Months

    PFS is defined as the time from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.

  3. Overall Survival (OS)

    Time frame: Through Study Completion, Up to Approximately 27 Months

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

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 2, Randomized Study to Evaluate the Optimized Dose, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab for Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Patients Who Have Progressed After an Immune Checkpoint Inhibitor Containing Regimen in First-Line HCC

Acronym: LIVIGNO-1

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2023
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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