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Monoclonal Antibodies

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

Phase 2

Recruiting

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

LIVIGNO-1 Trial Summary

This trial is studying an experimental combination of two drugs to treat HCC with up to 120 patients participating. Patients will receive infusions of the drugs, and will have to attend regular visits.

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.Check my eligibility

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.See study design

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.

LIVIGNO-1 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best Overall Response (BOR) per Investigator

Secondary outcome measures

Duration of response (DOR) per Investigator

Number of Participants with Progression-free Survival (PFS)

Overall Survival (OS)

LIVIGNO-1 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,270 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

146,989 Total Patients Enrolled

Media Library

Budigalimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05822752 — Phase 2

Liver Cancer Research Study Groups: Arm 1: Lenvatinib or Sorafenib, Arm 2: Livmoniplimab Dose A + Budigalimab, Arm 3: Livmoniplimab Dose B + Budigalimab

Liver Cancer Clinical Trial 2023: Budigalimab Highlights & Side Effects. Trial Name: NCT05822752 — Phase 2

Budigalimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05822752 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a number of medical facilities actively participating in the trial within this urban area?

"At present, there are 59 active clinical sites for this trial. These locations can be found in Springdale, Los Angeles and Orange County as well as numerous other places. To reduce travel time when signing up, it is beneficial to select the nearest available centre."

Answered by AI

What have been the results of administering Arm 2: Livmoniplimab Dose A + Budigalimab to human subjects?

"Our internal assessment of the safety profile for Arm 2: Livmoniplimab Dose A + Budigalimab is a level 2, due to the presence of some clinical data concerning its security but no evidence thus far supporting efficacy."

Answered by AI

Are there any vacant slots for participants in this experiment?

"Per the data available on clinicaltrials.gov, no more participants are being accepted for this trial. It was initially posted on July 29th 2023 and last edited April 10th 2023; however, there remains an abundance of other active studies that require volunteers at this time (2,657)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Budigalimab in Adult Participants With Hepatocellular Carcinoma (HCC)

2023. "Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Budigalimab in Adult Participants With Hepatocellular Carcinoma (HCC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05822752.

All > Hcc > Hepatocellular Carcinoma