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) (LIVIGNO-1)

AbbVie

Status and phase: Active, not recruiting; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Sorafenib; Drug: Livmoniplimab; Drug: Budigalimab; Drug: Lenvatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05822752

2022-502948-13-00 (Other Identifier)

M24-147

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 3 patient groups

Arm 1: Lenvatinib or Sorafenib

Active Comparator group

Description:

Participants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period.

Treatment:

Drug: Lenvatinib

Drug: Sorafenib

Arm 2: Livmoniplimab Dose A + Budigalimab

Experimental group

Description:

Participants will receive Livmoniplimab Dose A in combination with budigalimab, as part of an approximately 2 year treatment period.

Treatment:

Drug: Budigalimab

Drug: Livmoniplimab

Arm 3: Livmoniplimab Dose B + Budigalimab

Experimental group

Description:

Participants will receive Livmoniplimab Dose B in combination with budigalimab, as part of an approximately 2 year treatment period.

Treatment:

Drug: Budigalimab

Drug: Livmoniplimab