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Clinical Trials List

Protocol NumberM24-147
NCT Number(ClinicalTrials.gov Identfier)NCT05822752
Active

2023-09-01 - 2027-04-30

Phase II

Not yet recruiting3

Recruiting6

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

  • Trial Applicant

    AbbVie

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/06/30

Investigators and Locations

Principal Investigator Sheng-Shun Yang Digestive System Department
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator TSUNG-HAO LIU Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Hsiang Huang Division of Family Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Lung Yu 無
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chang-Fang Chiu Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 盧勝男 Digestive System Department
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 饒坤銘 Division of Hematology & Oncology
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Hepatocellular Carcinoma

Objectives

Primary Objectives: 1. To optimize the dose of livmoniplimab and budigalimab in combination therapy and identify a recommended phase 3 dose in patients with locally advanced or metastatic Child-Pugh A HCC who have progressed after a 1L course of HCC treatment containing an immune CPI. 2. To evaluate the efficacy of livmoniplimab and budigalimab combination therapy, measured by the best overall response (BOR) rate of confirmed complete response (CR)/partial response (PR) as determined by the trial administrator. Secondary Objectives: 1. To evaluate the efficacy of livmoniplimab and budigalimab combination therapy, measured by the duration of response (DoR) as determined by the trial administrator, progression-free survival (PFS) as determined by the trial administrator, and overall survival (OS). 2. To evaluate the safety, tolerability, immunogenicity, and pharmacokinetics (PK) of livmoniplimab and budigalimab combination therapy.

Test Drug

N/A
N/A
N/A
N/A

Active Ingredient

Livmoniplimab
Budigalimab
Lenvatinib
Sorafenib

Dosage Form

N/A
N/A
N/A
N/A

Dosage

N/A

Endpoints

The primary endpoint is the best overall response (BOR) at any time point prior to subsequent anticancer treatment, as determined by the trial administrator according to RECIST 1.1, whether it is a confirmed complete response (CR) or a confirmed partial response (PR).

Inclution Criteria

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

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.

The Estimated Number of Participants

  • Taiwan

    24 participants

  • Global

    120 participants

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