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)
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT05822752
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2: Livmoniplimab Dose A + Budigalimab Livmoniplimab Participants will receive Livmoniplimab Dose A in combination with budigalimab, as part of an approximately 2 year treatment period. Arm 3: Livmoniplimab Dose B + Budigalimab Livmoniplimab Participants will receive Livmoniplimab Dose B in combination with budigalimab, as part of an approximately 2 year treatment period. Arm 1: Lenvatinib or Sorafenib Lenvatinib Participants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period. Arm 1: Lenvatinib or Sorafenib Sorafenib Participants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period. Arm 3: Livmoniplimab Dose B + Budigalimab Budigalimab Participants will receive Livmoniplimab Dose B in combination with budigalimab, as part of an approximately 2 year treatment period. Arm 2: Livmoniplimab Dose A + Budigalimab Budigalimab Participants will receive Livmoniplimab Dose A in combination with budigalimab, as part of an approximately 2 year treatment period.
- Primary Outcome Measures
Name Time Method 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 anticancer therapy.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (59)
Rocky Mountain Cancer Centers - Denver Midtwon /ID# 254163
🇺🇸Denver, Colorado, United States
IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 253247
🇮🇹Bologna, Emilia-Romagna, Italy
Arizona Oncology Associates, PC - NAHOA Prescott Valley /ID# 254313
🇺🇸Prescott Valley, Arizona, United States
Highlands Oncology Group, PA /ID# 253158
🇺🇸Springdale, Arkansas, United States
University of California, Los Angeles /ID# 253292
🇺🇸Los Angeles, California, United States
UC Irvine /ID# 252707
🇺🇸Orange, California, United States
California Pacific Medical Center - San Francisco - Webster Street /ID# 253291
🇺🇸San Francisco, California, United States
AdventHealth Orlando /ID# 252865
🇺🇸Orlando, Florida, United States
The University of Chicago Medical Center /ID# 252870
🇺🇸Chicago, Illinois, United States
Hematology/Oncology Clinic /ID# 253851
🇺🇸Baton Rouge, Louisiana, United States
Dana-Farber Cancer Institute /ID# 252696
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital /ID# 253342
🇺🇸Detroit, Michigan, United States
Washington University-School of Medicine /ID# 252698
🇺🇸Saint Louis, Missouri, United States
NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 252708
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252705
🇺🇸New York, New York, United States
Messino Cancer Center - Asheville /ID# 253888
🇺🇸Asheville, North Carolina, United States
University of North Carolina /ID# 252739
🇺🇸Chapel Hill, North Carolina, United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 252699
🇺🇸Providence, Rhode Island, 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
Texas Oncology - Northeast Texas /ID# 254184
🇺🇸Tyler, Texas, United States
Centre Hospitalier Universitaire de Bordeaux /ID# 252749
🇫🇷Pessac CEDEX, Gironde, France
CHU Montpellier - Hopital Saint Eloi /ID# 252760
🇫🇷Montpellier Cedex 5, Herault, 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
AP-HP - Hopital Paul-Brousse /ID# 253646
🇫🇷Villejuif, France
Azienda Ospedaliero Universitaria Careggi /ID# 254444
🇮🇹Florence, Firenze, Italy
IRCCS Ospedale San Raffaele /ID# 252910
🇮🇹Milan, Milano, Italy
P.O. Ospedale del Mare /ID# 253140
🇮🇹Naples, Napoli, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 253142
🇮🇹Palermo, Italy
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 253141
🇮🇹Roma, Italy
Chiba University Hospital /ID# 255190
🇯🇵Chiba-shi, Chiba, Japan
National Cancer Center Hospital East /ID# 253419
🇯🇵Kashiwa-shi, Chiba, Japan
Kanazawa University Hospital /ID# 254861
🇯🇵Kanazawa-shi, Ishikawa, Japan
Yokohama City University Medical Center /ID# 255790
🇯🇵Yokohama shi, Kanagawa, Japan
Kindai University Hospital /ID# 255106
🇯🇵Osakasayama-shi, Osaka, Japan
Seoul National University Bundang Hospital /ID# 253412
🇰🇷Seongnam-si, Gyeonggido, Korea, Republic of
CHA Bundang Medical Center /ID# 253054
🇰🇷Seongnam, Gyeonggido, Korea, Republic of
Chonnam National University Hwasun Hospital /ID# 253133
🇰🇷Hwasun-gun, Jeonranamdo, Korea, Republic of
Asan Medical Center /ID# 253044
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center /ID# 253411
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Hospital Universitario Marques de Valdecilla /ID# 253059
🇪🇸Santander, Cantabria, Spain
Hospital Universitario Reina Sofia /ID# 253083
🇪🇸Córdoba, Cordoba, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253078
🇪🇸Majadahonda, Madrid, Spain
Clinica Universidad de Navarra - Pamplona /ID# 253073
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario Vall d'Hebron /ID# 253063
🇪🇸Barcelona, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 254840
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocio /ID# 253074
🇪🇸Sevilla, Spain
Hospital Universitario Miguel Servet /ID# 253071
🇪🇸Zaragoza, Spain
E-DA Cancer Hospital /ID# 260881
🇨🇳Kaohsiung City, Kaohsiung, Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 253675
🇨🇳Kaohsiung City, Kaohsiung, Taiwan
National Taiwan University Hospital /ID# 253449
🇨🇳Taipei City, Taipei, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 253451
🇨🇳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
Linkou Chang Gung Memorial Hospital /ID# 253674
🇨🇳Taoyuan City, Taiwan