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)

Sponsor

AbbVie (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05822752

Collaborator

(none)

120

Enrollment

Locations

Arms

40.8

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: Budigalimab Drug: Livmoniplimab Drug: Lenvatinib Drug: Sorafenib	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jul 29, 2023

Anticipated Primary Completion Date :

Dec 23, 2026

Anticipated Study Completion Date :

Dec 23, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1: Lenvatinib or Sorafenib Participants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period.	Drug: Lenvatinib Oral: Capsule Drug: Sorafenib Oral: Tablet
Experimental: Arm 2: Livmoniplimab Dose A + Budigalimab Participants will receive Livmoniplimab Dose A in combination with budigalimab, as part of an approximately 2 year treatment period.	Drug: Budigalimab Intravenous (IV) Infusion Other Names: ABBV-181 Drug: Livmoniplimab Intravenous (IV) Infusion Other Names: ABBV-151
Experimental: Arm 3: Livmoniplimab Dose B + Budigalimab Participants will receive Livmoniplimab Dose B in combination with budigalimab, as part of an approximately 2 year treatment period.	Drug: Budigalimab Intravenous (IV) Infusion Other Names: ABBV-181 Drug: Livmoniplimab Intravenous (IV) Infusion Other Names: ABBV-151

Arm

Intervention/Treatment

Active Comparator: Arm 1: Lenvatinib or Sorafenib

Participants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period.

Drug: Lenvatinib

Oral: Capsule

Drug: Sorafenib

Oral: Tablet

Experimental: Arm 2: Livmoniplimab Dose A + Budigalimab

Participants will receive Livmoniplimab Dose A in combination with budigalimab, as part of an approximately 2 year treatment period.

Drug: Budigalimab

Intravenous (IV) Infusion

Other Names:

ABBV-181

Drug: Livmoniplimab

Intravenous (IV) Infusion

Other Names:

ABBV-151

Experimental: Arm 3: Livmoniplimab Dose B + Budigalimab

Participants will receive Livmoniplimab Dose B in combination with budigalimab, as part of an approximately 2 year treatment period.

Drug: Budigalimab

Intravenous (IV) Infusion

Other Names:

ABBV-181

Drug: Livmoniplimab

Intravenous (IV) Infusion

Other Names:

ABBV-151

Outcome Measures

Primary Outcome Measures

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 antineoplastic therapy.

Secondary Outcome Measures

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.
Overall Survival (OS) [Through Study Completion, Up to Approximately 27 Months]
OS is defined as the time from randomization until death from any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 curative 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 3 or higher interstitial lung disease/pneumonitis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Oncology Associates, PC - NAHOA Prescott Valley /ID# 254313	Prescott Valley	Arizona	United States	86314
2	Highlands Oncology Group, PA /ID# 253158	Springdale	Arkansas	United States	72762
3	University of California, Los Angeles /ID# 253292	Los Angeles	California	United States	90095
4	UC Irvine /ID# 252707	Orange	California	United States	92868
5	California Pacific Medical Center /ID# 253291	San Francisco	California	United States	94115
6	UCHSC Anschultz Cancer Pavilion /ID# 253130	Aurora	Colorado	United States	80045-2517
7	Rocky Mountain Cancer Centers - Denver Midtown /ID# 254163	Denver	Colorado	United States	80218
8	AdventHealth Cancer Institute - Orlando /ID# 252865	Orlando	Florida	United States	32804
9	The University of Chicago Medical Center /ID# 252870	Chicago	Illinois	United States	60637-1443
10	Hematology/Oncology Clinic /ID# 253851	Baton Rouge	Louisiana	United States	70809
11	Dana-Farber Cancer Institute /ID# 252696	Boston	Massachusetts	United States	02215
12	Henry Ford Hospital /ID# 253342	Detroit	Michigan	United States	48202
13	Washington University-School of Medicine /ID# 252698	Saint Louis	Missouri	United States	63110
14	NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 252708	New York	New York	United States	10016-4744
15	Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252705	New York	New York	United States	10065-6007
16	Messino Cancer Center - Asheville /ID# 253888	Asheville	North Carolina	United States	28806-2316
17	University of North Carolina /ID# 252739	Chapel Hill	North Carolina	United States	27514
18	Lifespan Cancer Institute at Rhode Island Hospital /ID# 252699	Providence	Rhode Island	United States	02903-4923
19	Texas Oncology - Medical City Dallas /ID# 254164	Dallas	Texas	United States	75230
20	Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 252770	Dallas	Texas	United States	75246-2003
21	Texas Oncology - Tyler /ID# 254184	Tyler	Texas	United States	75702
22	CHU Bordeaux - Hopital Haut Leveque /ID# 252749	Pessac	Gironde	France	33604
23	CHRU Lille - Hopital Claude Huriez /ID# 252748	Lille	Hauts-de-France	France	59037
24	CHU Montpellier - Hôpital Saint Eloi /ID# 252760	Montpellier Cedex 5	Herault	France	34295
25	Hopital Beaujon /ID# 252758	Clichy	Ile-de-France	France	92110
26	CHU Grenoble - Hopital Michallon /ID# 252755	La Tronche		France	38700
27	AP-HP - Hopital Paul-Brousse /ID# 253646	Villejuif		France	94800
28	Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 253141	Rome	Lazio	Italy	00128
29	Ospedale San Raffaele IRCCS /ID# 252910	Milan	Milano	Italy	20132
30	P.O. Ospedale del Mare /ID# 253140	Naples	Napoli	Italy	80147
31	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 253247	Bologna		Italy	40138
32	Azienda Ospedaliero Universitaria Careggi /ID# 254444	Florence		Italy	50134
33	Istituto Oncologico Veneto /ID# 254382	Padova		Italy	35128
34	Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 253142	Palermo		Italy	90127
35	Chiba University Hospital /ID# 255190	Chiba-shi	Chiba	Japan	260-8677
36	National Cancer Center Hospital East /ID# 253419	Kashiwa-shi	Chiba	Japan	277-8577
37	Kanazawa University Hospital /ID# 254861	Kanazawa-shi	Ishikawa	Japan	920-8641
38	Kindai University Hospital /ID# 255106	Osakasayama-shi	Osaka	Japan	589-8511
39	CHA University Bundang Medical Center /ID# 253054	Seongnam si	Gyeonggido	Korea, Republic of	13496
40	Seoul National University Bundang Hospital /ID# 253412	Seongnam	Gyeonggido	Korea, Republic of	13620
41	Chonnam National University Hwasun Hospital /ID# 253133	Jeonnam		Korea, Republic of	58128
42	Asan Medical Center /ID# 253044	Seoul		Korea, Republic of	05505
43	Samsung Medical Center /ID# 253411	Seoul		Korea, Republic of	06351
44	Hospital Unversitario Marques de Valdecilla /ID# 253059	Santander	Cantabria	Spain	39008
45	Hospital Universitario Puerta de Hierro, Majadahonda /ID# 253078	Majadahonda	Madrid	Spain	28222
46	CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 253073	Pamplona	Navarra	Spain	31008
47	Hospital Universitario Vall d'Hebron /ID# 253063	Barcelona		Spain	08035
48	Hospital Universitario Reina Sofia /ID# 253083	Cordoba		Spain	14004
49	CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 254840	Madrid		Spain	28027
50	Hospital Universitario Virgen del Rocio /ID# 253074	Sevilla		Spain	41013
51	Hospital Universitario Miguel Servet /ID# 253071	Zaragoza		Spain	50009
52	Kaohsiung Chang Gung Memorial Hospital /ID# 253675	Kaohsiung City	Kaohsiung	Taiwan	833
53	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 253451	Kaohsiung		Taiwan	807
54	China Medical University Hospital /ID# 253453	Taichung City		Taiwan	40447
55	Taichung Veterans General Hospital /ID# 253452	Taichung		Taiwan	40705
56	National Cheng Kung University Hospital /ID# 253676	Tainan		Taiwan	704
57	National Taiwan University Hospital /ID# 253449	Taipei City		Taiwan	100
58	Taipei Veterans General Hosp /ID# 253450	Taipei City		Taiwan	11217
59	Linkou Chang Gung Memorial Hospital /ID# 253674	Taoyuan City		Taiwan	333