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Checkpoint Inhibitor

Livmoniplimab + Budigalimab 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
No Placebo-Only Group

Summary

This trial tests a new treatment combining two drugs, livmoniplimab and budigalimab, for adults with advanced liver cancer. The goal is to find the best dose and check for side effects and effectiveness. The treatment helps the immune system fight cancer cells.

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).
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to approximately 56 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to approximately 56 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Stage 1: Best Overall Response (BOR) per Investigator
Stage 2: Overall Survival (OS)
Secondary study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for liver cancer, particularly those involving immune modulation and immune checkpoint inhibition, work by enhancing the body's immune response against cancer cells. Immune modulators like Livmoniplimab stimulate the immune system to better recognize and attack cancer cells. Immune checkpoint inhibitors such as Budigalimab block proteins that prevent immune cells from attacking cancer cells, thereby allowing the immune system to target and destroy the cancer. This approach is crucial for liver cancer patients as it provides a targeted treatment option that can potentially improve outcomes in advanced or unresectable cases.

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,020 Previous Clinical Trials
519,468 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
442 Previous Clinical Trials
159,917 Total Patients Enrolled
~440 spots leftby Sep 2030