Clinical trial NCT05822752: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Lenvatinib
Sorafenib
Livmoniplimab
Budigalimab
ABBV-181
ABBV-151
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-04-21
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Best Overall Response (BOR) per Investigator
timeFrame: Through Study Completion, Up to Approximately 27 Months
Secondary outcomes:
measure: Duration of response (DOR) per Investigator
timeFrame: Through Study Completion, Up to Approximately 27 Months
measure: Number of Participants with Progression-free Survival (PFS)
timeFrame: Through Study Completion, Up to Approximately 27 Months
measure: Overall Survival (OS)
timeFrame: Through Study Completion, Up to Approximately 27 Months
Other outcomes:
Locations:
city: Prescott Valley
country: United States
facility: Arizona Oncology Associates, PC - NAHOA Prescott Valley /ID# 254313
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group, PA /ID# 253158
state: Arkansas
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 253292
state: California
city: Orange
country: United States
facility: UC Irvine /ID# 252707
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - San Francisco - Webster Street /ID# 253291
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers - Denver Midtwon /ID# 254163
state: Colorado
city: Orlando
country: United States
facility: AdventHealth Orlando /ID# 252865
state: Florida
city: Chicago
country: United States
facility: The University of Chicago Medical Center /ID# 252870
state: Illinois
city: Baton Rouge
country: United States
facility: Hematology/Oncology Clinic /ID# 253851
state: Louisiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute /ID# 252696
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital /ID# 253342
state: Michigan
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 252698
state: Missouri
city: New York
country: United States
facility: NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 252708
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252705
state: New York
city: Asheville
country: United States
facility: Messino Cancer Center - Asheville /ID# 253888
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina /ID# 252739
state: North Carolina
city: Providence
country: United States
facility: Lifespan Cancer Institute at Rhode Island Hospital /ID# 252699
state: Rhode Island
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas /ID# 254164
state: Texas
city: Dallas
country: United States
facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 252770
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Northeast Texas /ID# 254184
state: Texas
city: Pessac CEDEX
country: France
facility: Centre Hospitalier Universitaire de Bordeaux /ID# 252749
state: Gironde
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hopital Saint Eloi /ID# 252760
state: Herault
city: Clichy
country: France
facility: Hopital Beaujon /ID# 252758
state: Ile-de-France
city: La Tronche
country: France
facility: CHU Grenoble - Hopital Michallon /ID# 252755
state: Isere
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez /ID# 252748
state: Nord
city: Villejuif
country: France
facility: AP-HP - Hopital Paul-Brousse /ID# 253646
city: Bologna
country: Italy
facility: IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 253247
state: Emilia-Romagna
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi /ID# 254444
state: Firenze
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele /ID# 252910
state: Milano
city: Naples
country: Italy
facility: P.O. Ospedale del Mare /ID# 253140
state: Napoli
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 253142
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico /ID# 253141
city: Chiba-shi
country: Japan
facility: Chiba University Hospital /ID# 255190
state: Chiba
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 253419
state: Chiba
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital /ID# 254861
state: Ishikawa
city: Yokohama shi
country: Japan
facility: Yokohama City University Medical Center /ID# 255790
state: Kanagawa
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 255106
state: Osaka
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital /ID# 253412
state: Gyeonggido
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center /ID# 253054
state: Gyeonggido
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital /ID# 253133
state: Jeonranamdo
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 253044
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 253411
state: Seoul Teugbyeolsi
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla /ID# 253059
state: Cantabria
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia /ID# 253083
state: Cordoba
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253078
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra - Pamplona /ID# 253073
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 253063
city: Madrid
country: Spain
facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 254840
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 253074
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet /ID# 253071
city: Kaohsiung City
country: Taiwan
facility: E-DA Cancer Hospital /ID# 260881
state: Kaohsiung
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital /ID# 253675
state: Kaohsiung
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 253449
state: Taipei
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 253451
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 253453
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital /ID# 253452
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 253676
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hosp /ID# 253450
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 253674
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: