What side effects are associated with this type of intervention?

Common treatments for liver cancer, particularly those involving immune modulation and checkpoint inhibition such as pembrolizumab, nivolumab, ipilimumab, livmoniplimab, and budigalimab, are associated with several side effects. These can include severe hepatic disorders, gastrointestinal toxicity, skin reactions, and immune-related adverse events. Patients may experience fatigue, rash, diarrhea, and elevated liver enzymes. Serious adverse events, though less common, can include severe liver damage, colitis, and pneumonitis. It is crucial for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for liver cancer that involve immune modulation and checkpoint inhibition. Sorafenib (Nexavar) was one of the first approved drugs, functioning as a tyrosine kinase inhibitor. More recently, immune checkpoint inhibitors such as pembrolizumab (Keytruda) and nivolumab (Opdivo) have been approved for advanced hepatocellular carcinoma (HCC). These drugs work by blocking the PD-1/PD-L1 pathway, enhancing the immune system's ability to target cancer cells. The combination of immune checkpoint inhibitors with other treatments, such as regorafenib, has also been explored to improve outcomes in HCC patients.

What other types of research exist?

Promising novel alternatives for liver cancer treatment in 2024 include: 1) Tremelimumab plus Durvalumab, which has shown efficacy in unresectable hepatocellular carcinoma. 2) Lenvatinib, a multi-kinase inhibitor, which has been effective in advanced hepatocellular carcinoma. 3) Sorafenib, another multi-kinase inhibitor, which remains a standard treatment option. Additionally, adoptive cell-based therapies and other antibody-based approaches are under development and may offer new treatment avenues.

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Monoclonal Antibodies

Livmoniplimab + Budigalimab for Liver Cancer (LIVIGNO-1 Trial)

Phase 2

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to approximately 27 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests new drugs, livmoniplimab and budigalimab, on adults with advanced liver cancer that can't be removed by surgery. The drugs are designed to help the immune system fight the cancer more effectively.

Who is the study for?

Adults with advanced liver cancer (HCC) who've had immune therapy but not specific tyrosine kinase inhibitors like sorafenib or lenvatinib. They should be fairly active and healthy enough for treatment, without severe liver problems like encephalopathy, uncontrolled ascites, or both HBV and HCV infections.

What is being tested?

The trial is testing the safety and effectiveness of two doses of Livmoniplimab combined with Budigalimab against standard oral treatments Lenvatinib or Sorafenib in adults with liver cancer. Participants are randomly assigned to one of three groups and treated every three weeks for up to two years.

What are the potential side effects?

Potential side effects include reactions at the infusion site, increased risk of infection due to immune system changes, fatigue, possible organ inflammation from immunotherapy drugs, as well as any typical chemotherapy-related issues such as nausea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to approximately 27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to approximately 27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to approximately 27 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

Best Overall Response (BOR) per Investigator

Secondary study objectives

Duration of response (DOR) per Investigator

Number of Participants with Progression-free Survival (PFS)

Overall Survival (OS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 3: Livmoniplimab Dose B + BudigalimabExperimental Treatment2 Interventions

Participants will receive Livmoniplimab Dose B in combination with budigalimab, as part of an approximately 2 year treatment period.

Group II: Arm 2: Livmoniplimab Dose A + BudigalimabExperimental Treatment2 Interventions

Participants will receive Livmoniplimab Dose A in combination with budigalimab, as part of an approximately 2 year treatment period.

Group III: Arm 1: Lenvatinib or SorafenibActive Control2 Interventions

Participants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Budigalimab

2021

Completed Phase 1

~170

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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, such as immune checkpoint inhibitors, work by enhancing the body's immune response against cancer cells. Drugs like Livmoniplimab and Budigalimab target proteins such as PD-1 and PD-L1, which are used by cancer cells to evade immune detection. By blocking these proteins, these treatments help the immune system recognize and attack cancer cells more effectively. This approach is significant for liver cancer patients as it offers a potential for improved outcomes by leveraging the body's natural defenses to combat the disease, especially in cases where traditional therapies may be less effective.