What side effects are associated with this type of intervention?

Common treatments for liver cancer involving immune modulation and immune checkpoint inhibition, such as Livmoniplimab and Budigalimab, often lead to immune-related adverse events. These include skin reactions (rash, pruritus), endocrine disorders (hypothyroidism, adrenal insufficiency), gastrointestinal issues (diarrhea, colitis), and hepatic toxicity (elevated liver enzymes, hepatitis). Severe adverse events can include pneumonitis, nephritis, and myocarditis, as these therapies can cause the immune system to attack normal tissues.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of liver cancer, particularly focusing on immune checkpoint inhibitors and immune modulation. Notably, sorafenib, a tyrosine kinase inhibitor, was one of the first systemic treatments approved for advanced hepatocellular carcinoma (HCC). More recently, immune checkpoint inhibitors such as nivolumab and pembrolizumab have been approved for HCC, leveraging the body's immune system to target cancer cells. These treatments are similar to the investigational drugs livmoniplimab and budigalimab being studied in combination for their potential to enhance immune response against liver cancer.

What other types of research exist?

Promising alternatives to Livmoniplimab in combination with Budigalimab for liver cancer patients include: 1) Atezolizumab in combination with Bevacizumab, which has shown efficacy in HCC. 2) Tremelimumab in combination with Durvalumab, another immune checkpoint inhibitor combination under investigation. These combinations are being evaluated in clinical trials and may offer effective treatment options for HCC patients.

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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

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 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

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

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

0 / 4Eligibility criteria met

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

1,004 Previous Clinical Trials

513,118 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

430 Previous Clinical Trials

155,438 Total Patients Enrolled

~440 spots leftby Sep 2030

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