Trial Title:
A Study to Assess the Dose, Adverse Events, and Change in Disease Activity of Livmoniplimab as an Intravenous (IV) Solution in Combination With Budigalimab as an IV Solution in Adult Participants With Hepatocellular Carcinoma (HCC)
NCT ID:
NCT06109272
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab
Atezolizumab
Durvalumab
Tremelimumab
Conditions: Keywords:
Hepatocellular Carcinoma
Livmoniplimab
ABBV-151
budigalimab
ABBV-181
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Livmoniplimab
Description:
Intravenous (IV) Solution
Arm group label:
Stage 1: Cohort 1
Arm group label:
Stage 1: Cohort 2
Arm group label:
Stage 2: Arm 1
Other name:
ABBV-151
Intervention type:
Drug
Intervention name:
Budigalimab
Description:
Intravenous (IV) Solution
Arm group label:
Stage 1: Cohort 1
Arm group label:
Stage 1: Cohort 2
Arm group label:
Stage 2: Arm 1
Other name:
ABBV-181
Intervention type:
Drug
Intervention name:
Durvalumab
Description:
Intravenous (IV) Solution
Arm group label:
Stage 1: Cohort 3 - Group 2 (Control)
Arm group label:
Stage 2: Arm 2 (Control)
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
Intravenous (IV) Solution
Arm group label:
Stage 1: Cohort 3 - Group 1 (Control)
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
Intravenous (IV) Solution
Arm group label:
Stage 1: Cohort 3 - Group 1 (Control)
Intervention type:
Drug
Intervention name:
Tremelimumab
Description:
Intravenous (IV) Solution
Arm group label:
Stage 1: Cohort 3 - Group 2 (Control)
Arm group label:
Stage 2: Arm 2 (Control)
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 2 stages to this study. In Stage 1, there are 3 treatment arms 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),
atezolizumab in combination with bevacizumab, or tremelimumab in combination with
durvalumab. In Stage 2, there are 2 treatments arms and participants will be randomized
in a 1:1 ratio. Participants will either receive livmoniplimab (optimized dose) in
combination with budigalimab or tremelimumab in combination with durvalumab.
Approximately 660 adult participants will be enrolled in the study across 185 sites
worldwide.
Stage 1: In arm 1, participants will receive intravenously (IV) infused livmoniplimab
(Dose 1) in combination with IV infused budigalimab, every 3 weeks. In arm 2,
participants will receive IV infused livmoniplimab (Dose 2) in combination with IV
infused budigalimab, every 3 weeks. In Arm 3 (control), participants will receive the
investigator's choice: IV atezolizumab in combination with IV bevacizumab every 3 weeks
or single dose IV tremelimumab in combination with IV durvalumab every 4 weeks. Stage 2:
In arm 1, participants will receive IV infused livmoniplimab (optimized dose) in
combination with IV infused budigalimab, every 3 weeks. In Arm 2 (control), participants
will receive single dose IV tremelimumab in combination with IV durvalumab every 4 weeks.
All participants will continue treatment until disease progression or discontinuation
criteria are met, whichever occurs first. The estimated duration of this study is about
56 months.
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:
- Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC)
with diagnosis confirmed by histology or cytology or clinically by American
Association for the Study of Liver Diseases criteria for participants with
cirrhosis.
- Barcelona Clinic Liver Cancer (BCLC) Stage B or C.
- Child-Pugh A or B7 classification (i.e., total Child-Pugh score of 5, 6, or 7).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Exclusion Criteria:
- Prior systemic therapy for HCC.
- Symptomatic, untreated, or actively progressing CNS metastases.
- History of malignancy other than HCC.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope /ID# 261468
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope at Orange County Lennar Foundation Cancer Center /ID# 261669
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Recruiting
Facility:
Name:
UC Irvine /ID# 255673
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Chicago Medical Center /ID# 255674
Address:
City:
Chicago
Zip:
60637-1443
Country:
United States
Status:
Recruiting
Facility:
Name:
Alliance for Multispecialty Research LLC Kansas City Oncology /ID# 256830
Address:
City:
Merriam
Zip:
66204
Country:
United States
Status:
Completed
Facility:
Name:
Norton Cancer Institute /ID# 260775
Address:
City:
Louisville
Zip:
40217-1395
Country:
United States
Status:
Recruiting
Facility:
Name:
Henry Ford Hospital /ID# 255803
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Phone:
(313) 916-8423
Facility:
Name:
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 256041
Address:
City:
Saint Louis Park
Zip:
55416
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University-School of Medicine /ID# 255720
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology - Abilene - Antilley Road /ID# 265820
Address:
City:
Abilene
Zip:
79606
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology - Dallas - Worth Street /ID# 265806
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Facility:
Name:
Baylor Scott and White Research Institute /ID# 260853
Address:
City:
Dallas
Zip:
76508-0001
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Phone:
254-724-1054
Facility:
Name:
Oncology and Hematology Associates of Southwest Virginia /ID# 265834
Address:
City:
Roanoke
Zip:
98684
Country:
United States
Status:
Recruiting
Facility:
Name:
Hôpital Avicenne /ID# 266005
Address:
City:
Bobigny
Zip:
93000
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Beaujon /ID# 256551
Address:
City:
Clichy
Zip:
92110
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Grenoble - Hopital Michallon /ID# 256627
Address:
City:
La Tronche
Zip:
38700
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Gustave Roussy /ID# 258460
Address:
City:
Villejuif Cedex
Zip:
94805
Country:
France
Status:
Recruiting
Facility:
Name:
IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 256412
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Facility:
Name:
IRCCS Istituto Clinico Humanitas /ID# 256684
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Facility:
Name:
IRCCS Ospedale San Raffaele /ID# 256404
Address:
City:
Milan
Zip:
20132
Country:
Italy
Status:
Recruiting
Facility:
Name:
P.O. Ospedale del Mare /ID# 256410
Address:
City:
Naples
Zip:
80147
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 256681
Address:
City:
Palermo
Zip:
90127
Country:
Italy
Status:
Recruiting
Facility:
Name:
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 256895
Address:
City:
Roma
Zip:
00128
Country:
Italy
Status:
Recruiting
Facility:
Name:
Puerto Rico Medical Research Center /ID# 262362
Address:
City:
Hato Rey
Zip:
00917
Country:
Puerto Rico
Status:
Recruiting
Facility:
Name:
Hospital Universitario Marques de Valdecilla /ID# 255769
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Reina Sofia /ID# 255779
Address:
City:
Córdoba
Zip:
14004
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 255778
Address:
City:
Majadahonda
Zip:
28222
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Vall d'Hebron /ID# 255771
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Gregorio Maranon /ID# 255772
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen del Rocio /ID# 255776
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Miguel Servet /ID# 255774
Address:
City:
Zaragoza
Zip:
50009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Phone:
976 76 55 00
Facility:
Name:
National Taiwan University Hospital /ID# 256168
Address:
City:
Taipei City
Zip:
100
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
China Medical University Hospital /ID# 256764
Address:
City:
Taichung
Zip:
40447
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taichung Veterans General Hospital /ID# 259405
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Cheng Kung University Hospital /ID# 256766
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Veterans General Hosp /ID# 256169
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Status:
Recruiting
Start date:
January 11, 2024
Completion date:
September 6, 2030
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/NCT06109272
https://www.abbvieclinicaltrials.com/study/?id=M24-052
