Livmoniplimab + Budigalimab for Liver Cancer

(LIVIGNO-1 Trial)

Recruiting at 81 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Must not be taking: Tyrosine kinase inhibitors

Disqualifiers: CNS metastases, Other malignancy, Encephalopathy, Ascites, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

130 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently on a tyrosine kinase inhibitor like sorafenib or lenvatinib, you may not be eligible for the trial.

What data supports the effectiveness of the drug combination Livmoniplimab + Budigalimab for liver cancer?

Lenvatinib, one of the drugs in the combination, is an FDA-approved treatment for advanced liver cancer and has shown potential effectiveness in clinical practice, especially after other treatments like atezolizumab plus bevacizumab. However, the specific effectiveness of the entire combination with Livmoniplimab and Budigalimab for liver cancer is not directly addressed in the available research. ^{1 2 3 4 5}

How is the drug combination of Livmoniplimab and Budigalimab for liver cancer different from other treatments?

This drug combination is unique because it includes Livmoniplimab and Budigalimab, which are not standard treatments for liver cancer. While Lenvatinib and Sorafenib are known treatments, the addition of these novel immunotherapy agents could offer a new approach by potentially enhancing the immune system's ability to fight cancer. ^{1 2 3 6 7}

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either lenvatinib or sorafenib, or livmoniplimab in combination with budigalimab, for up to 2 years

Up to 2 years

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 months

Treatment Details

Interventions

• Budigalimab
• Lenvatinib
• Livmoniplimab
• Sorafenib

Trial Overview 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.

Participant Groups

Group I: Arm 3: Livmoniplimab Dose B + Budigalimab Experimental Treatment 2 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 + Budigalimab Experimental Treatment 2 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 Sorafenib Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

In a study of 53 patients with advanced hepatocellular carcinoma (HCC) who received lenvatinib after immunotherapy, the median overall survival was 12.8 months, indicating that lenvatinib can be an effective second-line treatment following immunotherapy failure.

The median progression-free survival was 3.7 months, suggesting that while lenvatinib provides some benefit, the optimal treatment sequence after immunotherapy for advanced HCC still needs further investigation through clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Patients with Advanced Hepatocellular Carcinoma Receiving Lenvatinib following Immunotherapy: A Real World Evidence Study. Palmer, ME., Gile, JJ., Storandt, MH., et al.[2023]

Atezolizumab plus bevacizumab significantly improves progression-free survival (PFS) compared to lenvatinib in patients with unresectable hepatocellular carcinoma (uHCC), based on a meta-analysis of 8 studies involving 3690 patients.

Patients receiving atezolizumab plus bevacizumab experience fewer severe adverse events (grade 3/4) compared to those treated with lenvatinib, indicating a better safety profile, although lenvatinib may be more effective for overall survival in non-viral patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of atezolizumab plus bevacizumab versus lenvatinib for unresectable hepatocellular carcinoma: a systematic review and meta-analysis. Liu, J., Yang, L., Wei, S., et al.[2023]

In a study of 13 patients, rechallenging with lenvatinib after treatment with atezolizumab plus bevacizumab showed anti-tumor effects, but the duration of the second lenvatinib treatment was significantly shorter (2.8 months) compared to the first treatment (8.7 months).

While lenvatinib re-administration can be effective, it may lead to deterioration in liver function, highlighting the need for careful monitoring of liver health and patient status during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rechallenge With Lenvatinib After Atezolizumab Plus Bevacizumab Treatment for Hepatocellular Carcinoma. Komatsu, S., Yano, Y., Kido, M., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Outcomes of Patients with Advanced Hepatocellular Carcinoma Receiving Lenvatinib following Immunotherapy: A Real World Evidence Study. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of atezolizumab plus bevacizumab versus lenvatinib for unresectable hepatocellular carcinoma: a systematic review and meta-analysis. [2023]

3. China pubmed.ncbi.nlm.nih.gov

Prolonged tumor response associated with sequential immune checkpoint inhibitor combination treatment and regorafenib in a patient with advanced pretreated hepatocellular carcinoma. [2020]

4. Greece pubmed.ncbi.nlm.nih.gov

Rechallenge With Lenvatinib After Atezolizumab Plus Bevacizumab Treatment for Hepatocellular Carcinoma. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Therapeutic potential of lenvatinib for unresectable hepatocellular carcinoma in clinical practice: Multicenter analysis. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

PD-1 inhibitors plus lenvatinib versus PD-1 inhibitors plus regorafenib in patients with advanced hepatocellular carcinoma after failure of sorafenib. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Review of therapies for intermediate and advanced stage hepatocellular carcinoma, not suitable for curative therapies: a rapidly changing landscape. [2020]