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Checkpoint Inhibitor
Stage 1: Cohort 1 for Liver Cancer (LIVIGNO-2 Trial)
Phase 2 & 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to approximately 56 months
Awards & highlights
LIVIGNO-2 Trial Summary
This trial is testing a new drug called livmoniplimab for the treatment of liver cancer. The study will enroll approximately 660 participants from around the world who have advanced liver cancer. In the
Who is the study for?
Adults with advanced liver cancer (HCC) that can't be surgically removed or has spread, confirmed by tests or clinical criteria. They should have a certain level of liver function (Child-Pugh A or B7) and be able to perform daily activities with little to no assistance (ECOG 0-1).Check my eligibility
What is being tested?
The trial is testing different doses of Livmoniplimab combined with Budigalimab against other treatments like Atezolizumab/Bevacizumab and Tremelimumab/Durvalumab in adults with HCC. Participants are randomly assigned to these groups and treated every few weeks until disease progression.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site, fatigue, nausea, changes in blood pressure, immune-related issues affecting organs, increased risk of infections due to weakened immunity, and possibly others not yet known.
LIVIGNO-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My liver cancer cannot be removed by surgery and is confirmed by tests or clinical criteria.
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My liver cancer is at an intermediate or advanced stage.
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My liver function is classified as Child-Pugh A or B7.
LIVIGNO-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to approximately 56 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to approximately 56 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Stage 1: Best Overall Response (BOR) per Investigator
Stage 2: Overall Survival (OS)
Secondary outcome measures
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
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)
Change from Baseline in the Fatigue Domain of the EORTC QLQ-HCC18
+10 moreLIVIGNO-2 Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Stage 2: Arm 1Experimental Treatment2 Interventions
Participants will receive livmoniplimab (optimized dose) in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met.
Group II: Stage 1: Cohort 2Experimental Treatment2 Interventions
Participants will receive livmoniplimab Dose 2 in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met.
Group III: Stage 1: Cohort 1Experimental Treatment2 Interventions
Participants will receive livmoniplimab Dose 1 in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met.
Group IV: Stage 2: Arm 2 (Control)Active Control2 Interventions
Participants will receive a single dose of tremelimumab in combination with durvalumab every 4 weeks until disease progression or until discontinuation criteria are met.
Group V: Stage 1: Cohort 3 - Group 1 (Control)Active Control2 Interventions
Participants will receive atezolizumab in combination with bevacizumab every 3 weeks until disease progression or until discontinuation criteria are met.
Group VI: Stage 1: Cohort 3 - Group 2 (Control)Active Control2 Interventions
Participants will receive a single dose of tremelimumab in combination with durvalumab every four weeks until disease progression or until discontinuation criteria are met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Budigalimab
2021
Completed Phase 1
~170
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
958 Previous Clinical Trials
501,730 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,449 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants currently being accepted for enrollment in this ongoing medical study?
"Indeed, as indicated by clinicaltrials.gov, this trial is currently in the recruitment phase. The initial posting of the trial took place on January 16th, 2024, and the most recent update was made on December 18th, 2023."
Answered by AI
What is the current number of individuals being enrolled in this research investigation?
"Indeed, the information available on clinicaltrials.gov indicates that this specific clinical trial is actively seeking individuals to participate. The trial was originally published on January 16th, 2024 and underwent its latest revision on December 18th, 2023. A total of 660 participants are being sought across a single research site."
Answered by AI
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