Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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 ID: NCT05822752
Conditions
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 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:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Rocky Mountain Cancer Centers - Denver Midtown /ID# 254163, Denver, Colorado, 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
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
Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 253141, Rome, Roma, Italy
Azienda Ospedaliero Universitaria Careggi /ID# 254444, Florence, , Italy
Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 253142, Palermo, , 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, , 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
Kaohsiung Chang Gung Memorial Hospital /ID# 253675, Kaohsiung City, Kaohsiung, Taiwan
National Taiwan University Hospital /ID# 253449, Taipei City, Taipei, Taiwan
E-DA Cancer Hospital /ID# 260881, Kaohsiung City, , 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
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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