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)

Trial Title: 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)

NCT ID: NCT05822752

Condition: Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Sorafenib
Lenvatinib

Conditions: Keywords:
Hepatocellular Carcinoma
Lenvatinib
Sorafenib
Livmoniplimab
Budigalimab
ABBV-181
ABBV-151
Cancer

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Budigalimab
Description: Intravenous (IV) Infusion
Arm group label: Arm 2: Livmoniplimab Dose A + Budigalimab
Arm group label: Arm 3: Livmoniplimab Dose B + Budigalimab

Other name: ABBV-181

Intervention type: Drug
Intervention name: Livmoniplimab
Description: Intravenous (IV) Infusion
Arm group label: Arm 2: Livmoniplimab Dose A + Budigalimab
Arm group label: Arm 3: Livmoniplimab Dose B + Budigalimab

Other name: ABBV-151

Intervention type: Drug
Intervention name: Lenvatinib
Description: Oral: Capsule
Arm group label: Arm 1: Lenvatinib or Sorafenib

Intervention type: Drug
Intervention name: Sorafenib
Description: Oral: Tablet
Arm group label: Arm 1: Lenvatinib or Sorafenib

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.

Criteria for eligibility:
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: - 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Arizona Oncology Associates, PC - NAHOA Prescott Valley /ID# 254313

Address:
City: Prescott Valley
Zip: 86314
Country: United States

Facility:
Name: Highlands Oncology Group, PA /ID# 253158

Address:
City: Springdale
Zip: 72762
Country: United States

Facility:
Name: University of California, Los Angeles /ID# 253292

Address:
City: Los Angeles
Zip: 90095
Country: United States

Facility:
Name: UC Irvine /ID# 252707

Address:
City: Orange
Zip: 92868
Country: United States

Facility:
Name: California Pacific Medical Center - San Francisco - Webster Street /ID# 253291

Address:
City: San Francisco
Zip: 94115
Country: United States

Facility:
Name: Rocky Mountain Cancer Centers - Denver Midtown /ID# 254163

Address:
City: Denver
Zip: 80218
Country: United States

Facility:
Name: AdventHealth Orlando /ID# 252865

Address:
City: Orlando
Zip: 32803
Country: United States

Facility:
Name: The University of Chicago Medical Center /ID# 252870

Address:
City: Chicago
Zip: 60637-1443
Country: United States

Facility:
Name: Hematology/Oncology Clinic /ID# 253851

Address:
City: Baton Rouge
Zip: 70809
Country: United States

Facility:
Name: Dana-Farber Cancer Institute /ID# 252696

Address:
City: Boston
Zip: 02215
Country: United States

Facility:
Name: Henry Ford Hospital /ID# 253342

Address:
City: Detroit
Zip: 48202
Country: United States

Facility:
Name: Washington University-School of Medicine /ID# 252698

Address:
City: Saint Louis
Zip: 63110
Country: United States

Facility:
Name: NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 252708

Address:
City: New York
Zip: 10016-4744
Country: United States

Facility:
Name: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252705

Address:
City: New York
Zip: 10065-6007
Country: United States

Facility:
Name: Messino Cancer Center - Asheville /ID# 253888

Address:
City: Asheville
Zip: 28806-2316
Country: United States

Facility:
Name: University of North Carolina /ID# 252739

Address:
City: Chapel Hill
Zip: 27514
Country: United States

Facility:
Name: Lifespan Cancer Institute at Rhode Island Hospital /ID# 252699

Address:
City: Providence
Zip: 02903-4923
Country: United States

Facility:
Name: Texas Oncology - Medical City Dallas /ID# 254164

Address:
City: Dallas
Zip: 75230
Country: United States

Facility:
Name: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 252770

Address:
City: Dallas
Zip: 75246-2003
Country: United States

Facility:
Name: Texas Oncology - Northeast Texas /ID# 254184

Address:
City: Tyler
Zip: 75702
Country: United States

Facility:
Name: Centre Hospitalier Universitaire de Bordeaux /ID# 252749

Address:
City: Pessac CEDEX
Zip: 33604
Country: France

Facility:
Name: CHU Montpellier - Hopital Saint Eloi /ID# 252760

Address:
City: Montpellier Cedex 5
Zip: 34295
Country: France

Facility:
Name: Hopital Beaujon /ID# 252758

Address:
City: Clichy
Zip: 92110
Country: France

Facility:
Name: CHU Grenoble - Hopital Michallon /ID# 252755

Address:
City: La Tronche
Zip: 38700
Country: France

Facility:
Name: CHRU Lille - Hopital Claude Huriez /ID# 252748

Address:
City: Lille
Zip: 59037
Country: France

Facility:
Name: AP-HP - Hopital Paul-Brousse /ID# 253646

Address:
City: Villejuif
Zip: 94800
Country: France

Facility:
Name: Azienda Ospedaliero Universitaria Careggi /ID# 254444

Address:
City: Florence
Zip: 50134
Country: Italy

Facility:
Name: IRCCS Ospedale San Raffaele /ID# 252910

Address:
City: Milan
Zip: 20132
Country: Italy

Facility:
Name: P.O. Ospedale del Mare /ID# 253140

Address:
City: Naples
Zip: 80147
Country: Italy

Facility:
Name: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 253247

Address:
City: Bologna
Zip: 40138
Country: Italy

Facility:
Name: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 253142

Address:
City: Palermo
Zip: 90127
Country: Italy

Facility:
Name: Fondazione Policlinico Universitario Campus Bio-Medico /ID# 253141

Address:
City: Roma
Zip: 00128
Country: Italy

Facility:
Name: Chiba University Hospital /ID# 255190

Address:
City: Chiba-shi
Zip: 260-8677
Country: Japan

Facility:
Name: National Cancer Center Hospital East /ID# 253419

Address:
City: Kashiwa-shi
Zip: 277-8577
Country: Japan

Facility:
Name: Kanazawa University Hospital /ID# 254861

Address:
City: Kanazawa-shi
Zip: 920-8641
Country: Japan

Facility:
Name: Yokohama City University Medical Center /ID# 255790

Address:
City: Yokohama shi
Zip: 232-0024
Country: Japan

Facility:
Name: Kindai University Hospital /ID# 255106

Address:
City: Osakasayama-shi
Zip: 589-8511
Country: Japan

Facility:
Name: Seoul National University Bundang Hospital /ID# 253412

Address:
City: Seongnam-si
Zip: 13620
Country: Korea, Republic of

Facility:
Name: CHA Bundang Medical Center /ID# 253054

Address:
City: Seongnam
Zip: 13496
Country: Korea, Republic of

Facility:
Name: Chonnam National University Hwasun Hospital /ID# 253133

Address:
City: Hwasun-gun
Zip: 58128
Country: Korea, Republic of

Facility:
Name: Asan Medical Center /ID# 253044

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center /ID# 253411

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: Hospital Universitario Marques de Valdecilla /ID# 253059

Address:
City: Santander
Zip: 39008
Country: Spain

Facility:
Name: Hospital Universitario Reina Sofia /ID# 253083

Address:
City: Córdoba
Zip: 14004
Country: Spain

Facility:
Name: Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253078

Address:
City: Majadahonda
Zip: 28222
Country: Spain

Facility:
Name: Clinica Universidad de Navarra - Pamplona /ID# 253073

Address:
City: Pamplona
Zip: 31008
Country: Spain

Facility:
Name: Hospital Universitario Vall d'Hebron /ID# 253063

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 254840

Address:
City: Madrid
Zip: 28027
Country: Spain

Facility:
Name: Hospital Universitario Virgen del Rocio /ID# 253074

Address:
City: Sevilla
Zip: 41013
Country: Spain

Facility:
Name: Hospital Universitario Miguel Servet /ID# 253071

Address:
City: Zaragoza
Zip: 50009
Country: Spain

Facility:
Name: E-DA Cancer Hospital /ID# 260881

Address:
City: Kaohsiung City
Zip: 82445
Country: Taiwan

Facility:
Name: Kaohsiung Chang Gung Memorial Hospital /ID# 253675

Address:
City: Kaohsiung City
Zip: 833
Country: Taiwan

Facility:
Name: National Taiwan University Hospital /ID# 253449

Address:
City: Taipei City
Zip: 100
Country: Taiwan

Facility:
Name: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 253451

Address:
City: Kaohsiung
Zip: 807
Country: Taiwan

Facility:
Name: China Medical University Hospital /ID# 253453

Address:
City: Taichung
Zip: 40447
Country: Taiwan

Facility:
Name: Taichung Veterans General Hospital /ID# 253452

Address:
City: Taichung
Zip: 40705
Country: Taiwan

Facility:
Name: National Cheng Kung University Hospital /ID# 253676

Address:
City: Tainan
Zip: 704
Country: Taiwan

Facility:
Name: Taipei Veterans General Hosp /ID# 253450

Address:
City: Taipei
Zip: 11217
Country: Taiwan

Facility:
Name: Linkou Chang Gung Memorial Hospital /ID# 253674

Address:
City: Taoyuan City
Zip: 333
Country: Taiwan

Start date: September 21, 2023

Completion date: November 26, 2026

Lead sponsor:
Agency: AbbVie
Agency class: Industry

Source: AbbVie

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05822752
https://www.abbvieclinicaltrials.com/study/?id=M24-147