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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504600-28-00 | Other Identifier | EU CT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1: Cohort 1 | Experimental | Participants will receive livmoniplimab Dose 1 in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met. |
|
| Stage 1: Cohort 2 | Experimental | Participants will receive livmoniplimab Dose 2 in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met. |
|
| Stage 1: Cohort 3 - Group 1 (Control) | Active Comparator | Participants will receive atezolizumab in combination with bevacizumab every 3 weeks until disease progression or until discontinuation criteria are met. |
|
| Stage 1: Cohort 3 - Group 2 (Control) | Active Comparator | Participants will receive a single dose of tremelimumab in combination with durvalumab every four weeks until disease progression or until discontinuation criteria are met. |
|
| Stage 2: Arm 1 | Experimental | Participants will receive livmoniplimab (optimized dose) in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Livmoniplimab | Drug | Intravenous (IV) Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: Best Overall Response (BOR) per Investigator | BOR is defined as a participant 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 56 Months |
| Stage 2: Overall Survival (OS) | OS is defined as the time from randomization until death from any cause | Through Study Completion, Up to Approximately 56 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: 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 56 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope /ID# 261468 | Recruiting | Duarte | California | 91010 | United States | |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Stage 2: Arm 2 (Control) | Active Comparator | Participants will receive a single dose of tremelimumab in combination with durvalumab every 4 weeks until disease progression or until discontinuation criteria are met. |
|
| Budigalimab | Drug | Intravenous (IV) Solution |
|
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| Durvalumab | Drug | Intravenous (IV) Solution |
|
| Atezolizumab | Drug | Intravenous (IV) Solution |
|
| Bevacizumab | Drug | Intravenous (IV) Solution |
|
| Tremelimumab | Drug | Intravenous (IV) Solution |
|
| Stage 1: 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 56 Months |
| Stage 1: Overall Survival (OS) | OS is defined as the time from randomization until death from any cause. | Through Study Completion, Up to Approximately 56 Months |
| Stage 1: Number of Participants with Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Through Study Completion, Up to Approximately 56 Months |
| Stage 1: Maximum Plasma Concentration (Cmax) of Livmoniplimab and Budigalimab | Cmax of livmoniplimab and budigalimab. | Through Study Completion, Up to Approximately 56 Months |
| Stage 1: Time to Cmax (Tmax) of Livmoniplimab and Budigalimab | Tmax of livmoniplimab and budigalimab. | Through Study Completion, Up to Approximately 56 Months |
| Stage 1: Area Under the Serum Concentration Versus Time Curve (AUC) of Livmoniplimab and Budigalimab | AUC of livmoniplimab and budigalimab. | Through Study Completion, Up to Approximately 56 Months |
| Stage 2: 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 blinded independent central review (BICR) or death from any cause, whichever occurs first. | Through Study Completion, Up to Approximately 56 Months |
| Stage 2: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) per BICR | BOR is defined as a participant achieving confirmed CR/PR per RECIST 1.1 as determined by BICR at any time prior to subsequent anticancer therapy. | Through Study Completion, Up to Approximately 56 Months |
| Change from Baseline in the Pain Domain of the European Organization for Research Treatment of Cancer Quality of Life Questionnaire Hepatocellular Carcinoma 18-Question Module (EORTC QLQ-HCC18) | The EORTC QLQ-HCC18 is an 18-item scale that measures hepatocellular carcinoma (HCC)-specific symptoms and health-related quality of life (HRQoL). The Pain Domain contains 2 items where scores are based on a 4-point Likert scale (with 1 = 'not at all' to 4 = 'very much'); scaled scores for each domain ranged from 0-100 with a higher score indicating worse symptoms. | Baseline to Week 12 |
| Change from Baseline in the Fatigue Domain of the EORTC QLQ-HCC18 | The EORTC QLQ-HCC18 is an 18-item scale that measures HCC-specific symptoms and HRQoL. The Fatigue Domain contains 3 items where scores are based on a 4-point Likert scale (with 1 = 'not at all' to 4 = 'very much'); scaled scores for each domain ranged from 0-100 with a higher score indicating worse symptoms. | Baseline to Week 12 |
| Change from Baseline in Physical Function (PF) Domain of the European Organization for Research Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) | The EORTC QLQ-C30 is an 30-item patient-reported questionnaire that measures symptoms and HRQoL. The PF Domain is a functional scale where participants rate items on a 4-point scale (with 1 = 'not at all' to 4 = 'very much'). A change of 5 to 10 points is considered a small change and the lower bound (5) will be used to define the minimum important difference. A change of >= 10 to < 20 points is considered a moderate change. | Baseline to Week 12 |
| Change from Baseline in Global Health Status (GHS)/Quality of Life (QoL) Domain as Measured by the GHS/QoL Domain of the EORTC QLQ-C30 | The EORTC QLQ-C30 is an 30-item patient-reported questionnaire that measures symptoms and HRQoL. The GHS/QoL Domain is a scale where participants rate items on a 4-point scale (with 1 = 'not at all' to 4 = 'very much'). A change of 5 to 10 points is considered a small change and the lower bound (5) will be used to define the minimum important difference. A change of ≥ 10 to < 20 points is considered a moderate change. | Baseline to Week 12 |
| City of Hope at Orange County Lennar Foundation Cancer Center /ID# 261669 |
| Recruiting |
| Irvine |
| California |
| 92618 |
| United States |
| UC Irvine /ID# 255673 | Recruiting | Orange | California | 92868 | United States |
| The University of Chicago Medical Center /ID# 255674 | Recruiting | Chicago | Illinois | 60637-1443 | United States |
| Alliance for Multispecialty Research LLC Kansas City Oncology /ID# 256830 | Completed | Merriam | Kansas | 66204 | United States |
| Norton Cancer Institute /ID# 260775 | Recruiting | Louisville | Kentucky | 40217-1395 | United States |
| Henry Ford Hospital /ID# 255803 | Recruiting | Detroit | Michigan | 48202 | United States |
|
| Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 256041 | Recruiting | Saint Louis Park | Minnesota | 55416 | United States |
| Washington University-School of Medicine /ID# 255720 | Recruiting | St Louis | Missouri | 63110 | United States |
| Texas Oncology - Abilene - Antilley Road /ID# 265820 | Recruiting | Abilene | Texas | 79606 | United States |
| Texas Oncology - Dallas - Worth Street /ID# 265806 | Recruiting | Dallas | Texas | 75246 | United States |
| Baylor Scott and White Research Institute /ID# 260853 | Recruiting | Dallas | Texas | 76508-0001 | United States |
|
| Oncology and Hematology Associates of Southwest Virginia /ID# 265834 | Recruiting | Roanoke | Virginia | 98684 | United States |
| CHU Grenoble - Hopital Michallon /ID# 256627 | Recruiting | La Tronche | Isere | 38700 | France |
| Institut Gustave Roussy /ID# 258460 | Recruiting | Villejuif | Val-de-Marne | 94805 | France |
| Hôpital Avicenne /ID# 266005 | Recruiting | Bobigny | Île-de-France Region | 93000 | France |
| Hopital Beaujon /ID# 256551 | Recruiting | Clichy | Île-de-France Region | 92110 | France |
| IRCCS Istituto Clinico Humanitas /ID# 256684 | Recruiting | Rozzano | Lombardy | 20089 | Italy |
| IRCCS Ospedale San Raffaele /ID# 256404 | Recruiting | Milan | Milano | 20132 | Italy |
| P.O. Ospedale del Mare /ID# 256410 | Recruiting | Naples | Napoli | 80147 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 265506 | Recruiting | Rome | Roma | 00168 | Italy |
| IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 256412 | Recruiting | Bologna | 40138 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 256681 | Recruiting | Palermo | 90127 | Italy |
| Fondazione Policlinico Universitario Campus Bio-Medico /ID# 256895 | Recruiting | Roma | 00128 | Italy |
| Puerto Rico Medical Research Center /ID# 262362 | Recruiting | Hato Rey | Puerto Rico | 00917 | Puerto Rico |
| Hospital Universitario Marques de Valdecilla /ID# 255769 | Recruiting | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario Reina Sofia /ID# 255779 | Recruiting | Córdoba | Cordoba | 14004 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda /ID# 255778 | Recruiting | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario Vall d'Hebron /ID# 255771 | Recruiting | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Maranon /ID# 255772 | Recruiting | Madrid | 28007 | Spain |
| Hospital Universitario Virgen del Rocio /ID# 255776 | Recruiting | Seville | 41013 | Spain |
| Hospital Universitario Miguel Servet /ID# 255774 | Recruiting | Zaragoza | 50009 | Spain |
|
| National Taiwan University Hospital /ID# 256168 | Recruiting | Taipei City | Taipei | 100 | Taiwan |
| China Medical University Hospital /ID# 256764 | Active, not recruiting | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital /ID# 259405 | Active, not recruiting | Taichung | 40705 | Taiwan |
| National Cheng Kung University Hospital /ID# 256766 | Recruiting | Tainan | 704 | Taiwan |
| Taipei Veterans General Hosp /ID# 256169 | Recruiting | Taipei | 11217 | Taiwan |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C000719868 | budigalimab |
| C000613593 | durvalumab |
| C000594389 | atezolizumab |
| D000068258 | Bevacizumab |
| C520704 | tremelimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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