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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Livmoniplimab, Budigalimab, Durvalumab, Atezolizumab.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, France, Italy, Puerto Rico, Spain +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 2/3, Randomized Study to Evaluate the Dose Optimization, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab in Subjects With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Treatment
Overview
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.
Interventions
- Drug Livmoniplimab
Intravenous (IV) Solution - Drug Budigalimab
Intravenous (IV) Solution - Drug Durvalumab
Intravenous (IV) Solution - Drug Atezolizumab
Intravenous (IV) Solution - Drug Bevacizumab
Intravenous (IV) Solution - Drug Tremelimumab
Intravenous (IV) Solution
Primary outcome measures
- Stage 1: Best Overall Response (BOR) per Investigator [Time frame: Through Study Completion, Up to Approximately 56 Months]
- Stage 2: Overall Survival (OS) [Time frame: Through Study Completion, Up to Approximately 56 Months]
Secondary outcome measures (12)
- Stage 1: Number of Participants with Progression-Free Survival (PFS) [Time frame: Through Study Completion, Up to Approximately 56 Months]
- Stage 1: Duration of Response (DOR) per Investigator [Time frame: Through Study Completion, Up to Approximately 56 Months]
- Stage 1: Overall Survival (OS) [Time frame: Through Study Completion, Up to Approximately 56 Months]
- Stage 1: Number of Participants with Adverse Events (AEs) [Time frame: Through Study Completion, Up to Approximately 56 Months]
- Stage 1: Maximum Plasma Concentration (Cmax) of Livmoniplimab and Budigalimab [Time frame: Through Study Completion, Up to Approximately 56 Months]
- Stage 1: Time to Cmax (Tmax) of Livmoniplimab and Budigalimab [Time frame: Through Study Completion, Up to Approximately 56 Months]
- Stage 1: Area Under the Serum Concentration Versus Time Curve (AUC) of Livmoniplimab and Budigalimab [Time frame: Through Study Completion, Up to Approximately 56 Months]
- Stage 2: Number of Participants with Progression-Free Survival (PFS) [Time frame: Through Study Completion, Up to Approximately 56 Months]
- Stage 2: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) per BICR [Time frame: 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) [Time frame: Baseline to Week 12]
- Change from Baseline in the Fatigue Domain of the EORTC QLQ-HCC18 [Time frame: 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) [Time frame: Baseline to Week 12]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 13 centers
- City of Hope /ID# 261468 — Duarte
- City of Hope at Orange County Lennar Foundation Cancer Center /ID# 261669 — Irvine
- UC Irvine /ID# 255673 — Orange
- The University of Chicago Medical Center /ID# 255674 — Chicago
- Alliance for Multispecialty Research LLC Kansas City Oncology /ID# 256830 — Merriam
- Norton Cancer Institute /ID# 260775 — Louisville
- Henry Ford Hospital /ID# 255803 — Detroit
- Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 256041 — Saint Louis Park
- … and 5 more centers
Italy · 7 centers
- IRCCS Istituto Clinico Humanitas /ID# 256684 — Rozzano
- IRCCS Ospedale San Raffaele /ID# 256404 — Milan
- P.O. Ospedale del Mare /ID# 256410 — Naples
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 2655 — Rome
- IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 256412 — Bologna
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 256681 — Palermo
- Fondazione Policlinico Universitario Campus Bio-Medico /ID# 256895 — Roma
Spain · 7 centers
- Hospital Universitario Marques de Valdecilla /ID# 255769 — Santander
- Hospital Universitario Reina Sofia /ID# 255779 — Córdoba
- Hospital Universitario Puerta de Hierro - Majadahonda /ID# 255778 — Majadahonda
- Hospital Universitario Vall d'Hebron /ID# 255771 — Barcelona
- Hospital General Universitario Gregorio Maranon /ID# 255772 — Madrid
- Hospital Universitario Virgen del Rocio /ID# 255776 — Seville
- Hospital Universitario Miguel Servet /ID# 255774 — Zaragoza
Taiwan · 5 centers
- National Taiwan University Hospital /ID# 256168 — Taipei City
- China Medical University Hospital /ID# 256764 — Taichung
- Taichung Veterans General Hospital /ID# 259405 — Taichung
- National Cheng Kung University Hospital /ID# 256766 — Tainan
- Taipei Veterans General Hosp /ID# 256169 — Taipei
France · 4 centers
- CHU Grenoble - Hopital Michallon /ID# 256627 — La Tronche
- Institut Gustave Roussy /ID# 258460 — Villejuif
- Hôpital Avicenne /ID# 266005 — Bobigny
- Hopital Beaujon /ID# 256551 — Clichy
Puerto Rico · 1 center
- Puerto Rico Medical Research Center /ID# 262362 — Hato Rey
Identifiers
NCT: NCT06109272 · M24-052 · 2023-504600-28-00