[M24-147] 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)

JRCT ID: jRCT2031230144

Registered date:16/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular Carcinoma
• Date of first enrollment: 29/07/2023
• Target sample size: 120
• Countries of recruitment: United States,Japan,France,Japan,Italy,Japan,Korea,Japan,Spain,Japan,Taiwan,Japan
• Study type: Interventional

Intervention(s)

Arm 1: Participants will receive Lenvatinib (oral, capsule) or or Sorafenib (oral, tablet), as part of an approximately 2 year treatment period.
Arm 2: Participants will receive Livmoniplimab Dose A (intravenous infusion) in combination with budigalimab (intravenous infusion), as part of an approximately 2 year treatment period.
Arm 3:Participants will receive Livmoniplimab Dose B (intravenous infusion) in combination with budigalimab (intravenous infusion), as part of an approximately 2 year treatment period.

Outcome(s)

• Primary Outcome: Best Overall Response (BOR) per Investigator

Secondary Outcome

Duration of response (DOR) per Investigator
Number of Participants with Progression-free Survival (PFS)
Overall Survival (OS)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies.

Exclude 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 3 or higher interstitial lung disease/pneumonitis.

Related Information

• Primary Sponsor: Yamagishi Chika
• Secondary ID(s): NCT05822752