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[M24-147] 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

[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)

Yamagishi Chika

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Patients and HCP Contact

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Not Recruiting

July. 29, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- 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.

- 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.

Both

Hepatocellular Carcinoma

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.

Best Overall Response (BOR) per Investigator

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

+81-3-3542-2511

Yes

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing.html

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