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)

Hepatocellular Carcinoma Clinical Trial

— LIVIGNO-1  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05822752
• Other study ID #: M24-147
• Secondary ID: 2022-502948-13-0
• Status: Recruiting
• Phase: Phase 2
• Start date: September 21, 2023
• Est. completion date: February 16, 2027

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 16, 2027
• Est. primary completion date: December 23, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Budigalimab
Intravenous (IV) Infusion
• Livmoniplimab
Intravenous (IV) Infusion
• Lenvatinib
Oral: Capsule
• Sorafenib
Oral: Tablet

Locations

Country	Name	City	State
France	Hopital Beaujon /ID# 252758	Clichy	Ile-de-France
France	CHU Grenoble - Hopital Michallon /ID# 252755	La Tronche	Isere
France	CHRU Lille - Hopital Claude Huriez /ID# 252748	Lille	Nord
France	CHU Montpellier - Hopital Saint Eloi /ID# 252760	Montpellier Cedex 5	Herault
France	Centre Hospitalier Universitaire de Bordeaux /ID# 252749	Pessac CEDEX	Gironde
Italy	Azienda Ospedaliero Universitaria Careggi /ID# 254444	Florence
Italy	Ospedale San Raffaele IRCCS /ID# 252910	Milan	Milano
Italy	Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 253142	Palermo
Italy	Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 253141	Rome	Roma
Japan	Chiba University Hospital /ID# 255190	Chiba-shi	Chiba
Japan	Kanazawa University Hospital /ID# 254861	Kanazawa-shi	Ishikawa
Japan	National Cancer Center Hospital East /ID# 253419	Kashiwa-shi	Chiba
Japan	Kindai University Hospital /ID# 255106	Osakasayama-shi	Osaka
Japan	Yokohama City University Medical Center /ID# 255790	Yokohama shi	Kanagawa
Korea, Republic of	Chonnam National University Hwasun Hospital /ID# 253133	Hwasun-gun	Jeonranamdo
Korea, Republic of	CHA Bundang Medical Center /ID# 253054	Seongnam	Gyeonggido
Korea, Republic of	Seoul National University Bundang Hospital /ID# 253412	Seongnam-si	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 253044	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 253411	Seoul
Spain	Hospital Universitario Vall d'Hebron /ID# 253063	Barcelona
Spain	Hospital Universitario Reina Sofia /ID# 253083	Córdoba	Cordoba
Spain	CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 254840	Madrid
Spain	Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253078	Majadahonda	Madrid
Spain	Clinica Universidad de Navarra - Pamplona /ID# 253073	Pamplona	Navarra
Spain	Hospital Universitario Marques de Valdecilla /ID# 253059	Santander	Cantabria
Spain	Hospital Universitario Virgen del Rocio /ID# 253074	Sevilla
Spain	Hospital Universitario Miguel Servet /ID# 253071	Zaragoza
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 253451	Kaohsiung
Taiwan	E-DA Cancer Hospital /ID# 260881	Kaohsiung City
Taiwan	Kaohsiung Chang Gung Memorial Hospital /ID# 253675	Kaohsiung City	Kaohsiung
Taiwan	China Medical University Hospital /ID# 253453	Taichung
Taiwan	Taichung Veterans General Hospital /ID# 253452	Taichung
Taiwan	National Cheng Kung University Hospital /ID# 253676	Tainan
Taiwan	Taipei Veterans General Hosp /ID# 253450	Taipei
Taiwan	National Taiwan University Hospital /ID# 253449	Taipei City	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 253674	Taoyuan City
United States	Messino Cancer Center - Asheville /ID# 253888	Asheville	North Carolina
United States	Hematology/Oncology Clinic /ID# 253851	Baton Rouge	Louisiana
United States	Dana-Farber Cancer Institute /ID# 252696	Boston	Massachusetts
United States	The University of Chicago Medical Center /ID# 252870	Chicago	Illinois
United States	Texas Oncology - Medical City Dallas /ID# 254164	Dallas	Texas
United States	Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 252770	Dallas	Texas
United States	Rocky Mountain Cancer Centers - Denver Midtown /ID# 254163	Denver	Colorado
United States	Henry Ford Hospital /ID# 253342	Detroit	Michigan
United States	University of California, Los Angeles /ID# 253292	Los Angeles	California
United States	Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252705	New York	New York
United States	NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 252708	New York	New York
United States	UC Irvine /ID# 252707	Orange	California
United States	AdventHealth Orlando /ID# 252865	Orlando	Florida
United States	Arizona Oncology Associates, PC - NAHOA Prescott Valley /ID# 254313	Prescott Valley	Arizona
United States	Lifespan Cancer Institute at Rhode Island Hospital /ID# 252699	Providence	Rhode Island
United States	Washington University-School of Medicine /ID# 252698	Saint Louis	Missouri
United States	California Pacific Medical Center - San Francisco - Webster Street /ID# 253291	San Francisco	California
United States	Highlands Oncology Group, PA /ID# 253158	Springdale	Arkansas
United States	Texas Oncology - Northeast Texas /ID# 254184	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  France,  Italy,  Japan,  Korea, Republic of,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Overall Response (BOR) per Investigator	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.	Through Study Completion, Up to Approximately 27 Months
Secondary	Duration of response (DOR) per Investigator	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.	Through Study Completion, Up to Approximately 27 Months
Secondary	Number of Participants with Progression-free Survival (PFS)	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.	Through Study Completion, Up to Approximately 27 Months
Secondary	Overall Survival (OS)	OS is defined as the time from randomization until death from any cause.	Through Study Completion, Up to Approximately 27 Months

External Links

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