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)

Phase 2

Active, not recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Lenvatinib; Drug: Budigalimab; Drug: Livmoniplimab; Drug: Sorafenib

• Registration Number: NCT05822752
• Lead Sponsor: AbbVie

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-04-10
• Study First Posted: 2023-04-21
• Study Start: 2023-09-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Livmoniplimab Dose A + Budigalimab	Livmoniplimab	Participants will receive Livmoniplimab Dose A in combination with budigalimab, as part of an approximately 2 year treatment period.
Arm 3: Livmoniplimab Dose B + Budigalimab	Livmoniplimab	Participants will receive Livmoniplimab Dose B in combination with budigalimab, as part of an approximately 2 year treatment period.
Arm 1: Lenvatinib or Sorafenib	Lenvatinib	Participants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period.
Arm 1: Lenvatinib or Sorafenib	Sorafenib	Participants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period.
Arm 3: Livmoniplimab Dose B + Budigalimab	Budigalimab	Participants will receive Livmoniplimab Dose B in combination with budigalimab, as part of an approximately 2 year treatment period.
Arm 2: Livmoniplimab Dose A + Budigalimab	Budigalimab	Participants will receive Livmoniplimab Dose A in combination with budigalimab, as part of an approximately 2 year treatment period.

Primary Outcome Measures

Name	Time	Method
Best Overall Response (BOR) per Investigator	Through Study Completion, Up to Approximately 27 Months	BOR is defined as a subject achieving confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by investigators at any time prior to subsequent anticancer therapy.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Through Study Completion, Up to Approximately 27 Months	OS is defined as the time from randomization until death from any cause.
Duration of response (DOR) per Investigator	Through Study Completion, Up to Approximately 27 Months	DOR is defined as the time from first confirmed CR or PR until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.
Number of Participants with Progression-free Survival (PFS)	Through Study Completion, Up to Approximately 27 Months	PFS is defined as the time from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.

Trial Locations

Locations (59)

Rocky Mountain Cancer Centers - Denver Midtwon /ID# 254163; 🇺🇸 Denver, Colorado, United States

IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 253247; 🇮🇹 Bologna, Emilia-Romagna, Italy

Arizona Oncology Associates, PC - NAHOA Prescott Valley /ID# 254313; 🇺🇸 Prescott Valley, Arizona, United States

Highlands Oncology Group, PA /ID# 253158; 🇺🇸 Springdale, Arkansas, United States

University of California, Los Angeles /ID# 253292; 🇺🇸 Los Angeles, California, United States

UC Irvine /ID# 252707; 🇺🇸 Orange, California, United States

California Pacific Medical Center - San Francisco - Webster Street /ID# 253291; 🇺🇸 San Francisco, California, United States

AdventHealth Orlando /ID# 252865; 🇺🇸 Orlando, Florida, United States

The University of Chicago Medical Center /ID# 252870; 🇺🇸 Chicago, Illinois, United States

Hematology/Oncology Clinic /ID# 253851; 🇺🇸 Baton Rouge, Louisiana, United States

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