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

Recruiting in Palo Alto (17 mi)

+81 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AbbVie

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Inclusion Criteria

My liver function is mildly affected.

I received an immune therapy as my first treatment for liver cancer.

Tissue biopsy at screening

See 3 more

Exclusion Criteria

I have had serious lung inflammation more than once.

Coinfection with active HBV infection and active HCV infection

I have had a severe reaction to immune therapy before.

See 5 more

Treatment Details

Interventions

Budigalimab (Monoclonal Antibodies)
Lenvatinib (Tyrosine Kinase Inhibitor)
Livmoniplimab (Monoclonal Antibodies)
Sorafenib (Tyrosine Kinase Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.