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Clinical Trials List

Protocol NumberM24-052

NCT Number(ClinicalTrials.gov Identfier)NCT06109272

2024-01-01 - 2030-11-30

Phase II/III

Recruiting5

A Phase 2/3, Randomized Study to Evaluate the Dose Optimization, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab in Subjects with Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Treatment –LIVIGNO-2

Trial Applicant

AbbVie
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2024/04/19

Investigators and Locations

Principal Investigator Chang-Fang Chiu 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ann-Lii Cheng 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Sheng-Shun Yang 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Hsiang Huang 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen Division of General Internal Medicine

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Hepatocellular Carcinoma

Objectives

main target Phase 1 - Selection of the optimal livmoniplimab dose from the Phase 3 trial plus budigalimab in subjects with locally advanced or metastatic HCC who have not received prior systemic therapy for hepatocellular carcinoma (HCC). Phase 2 - To evaluate the efficacy of the combination of livmoniplimab and budigalimab in terms of overall survival (OS) in subjects with locally advanced or metastatic HCC who have not received prior systemic therapy for HCC. secondary goals Phase 1 and 2 - Evaluate the safety, tolerability, immunogenicity, and pharmacokinetics (PK) of livmoniplimab concurrently with budigalimab. Phase 2 - To evaluate the efficacy of livmoniplimab plus budigalimab based on progression-free survival (PFS), best overall response (BOR) of complete response (CR)/partial response (PR), and duration of response (DoR). Phase 2 - Evaluate the impact of livmoniplimab concomitantly with budigalimab on patient-reported outcomes (PROs).

Test Drug

Livmoniplimab (ABBV-151)；Budigalimab (ABBV-181)

Active Ingredient

Livmoniplimab (ABBV-151)
Budigalimab (ABBV-181)

Dosage Form

Solution for Infusion
Powder for Solution for Infusion

Dosage

NA

Endpoints

The primary indicator for Phase 1 is BOR of CR/PR as assessed by the trial moderator based on RECIST 1.1.
The primary metric for Phase 2 is OS.

Inclution Criteria

1.Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology or cytology or clinically by American Association for the Study of Liver Diseases criteria for participants with cirrhosis.
2.Barcelona Clinic Liver Cancer (BCLC) Stage B or C.
3.Child-Pugh A or B7 classification (i.e., total Child-Pugh score of 5, 6, or 7).
4.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

Exclusion Criteria

1.Prior systemic therapy for HCC.
2.Symptomatic, untreated, or actively progressing CNS metastases.
3.History of malignancy other than HCC.

The Estimated Number of Participants

Taiwan

26 participants
Global

660 participants