Livmoniplimab + Budigalimab for Liver Cancer

(LIVIGNO-1 Trial)

Not currently recruiting at 98 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose and assess the side effects of a new treatment combination for liver cancer, specifically hepatocellular carcinoma (HCC). Participants will receive either traditional treatments (lenvatinib or sorafenib) or a combination of investigational drugs, livmoniplimab and budigalimab. The trial targets individuals with liver cancer that cannot be treated with surgery or other local treatments. Participants should have previously received an immune checkpoint inhibitor as part of their treatment. The trial may require regular hospital visits for tests and assessments over two years. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using livmoniplimab with budigalimab may help treat advanced cancers. One study found that when livmoniplimab was used with a similar drug, 42% of patients with liver cancer experienced some improvement, indicating positive changes for nearly half of the patients.

Additionally, when budigalimab was combined with another experimental drug, most participants did not experience serious side effects, suggesting it was generally well-tolerated. However, these results are preliminary, and further research is necessary to confirm the safety and effectiveness of this treatment combination.

As this trial is in an early phase, there is some evidence of safety, but the treatment is still under careful study to ensure it is safe for broader use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Livmoniplimab combined with Budigalimab for treating liver cancer because these drugs target the immune system in a novel way. Unlike traditional treatments like Sorafenib and Lenvatinib, which primarily inhibit tumor growth by blocking specific proteins, Livmoniplimab and Budigalimab work by enhancing the body's immune response to fight cancer cells more effectively. This approach could potentially improve outcomes for patients by offering a more targeted attack on cancer cells, leading to better survival rates and fewer side effects. Additionally, the combination of these two drugs might provide a synergistic effect, making the treatment more potent than using a single agent alone.

What evidence suggests that this trial's treatments could be effective for liver cancer?

In this trial, participants will receive different treatments to evaluate their effectiveness for liver cancer. Research has shown that using Livmoniplimab and Budigalimab together, which participants may receive in Arm 2 or Arm 3, may help treat liver cancer. In a past study with liver cancer patients, nearly half experienced tumor shrinkage or disappearance with this combination. Budigalimab alone has also improved outcomes in patients with advanced solid tumors. These results suggest that this combination could be effective for liver cancer, but further research is needed to confirm its benefits. ^{1 2 3 4 5}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

My condition cannot be treated with surgery or localized treatments, or it got worse after such treatments.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS4190

Phase 2/3 study of livmoniplimab in combination with ... A phase 1 study in HCC showed an overall response rate (ORR) of 42% (5/12) when combining livmoniplimab with the programmed cell death 1 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06109272

NCT06109272 | A Study to Assess the Dose, Adverse ... The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab. Livmoniplimab is an ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06487559

NCT06487559 | A Study to Assess the Adverse Events and ... The purpose of this study is to assess adverse events and how livmoniplimab in combination with budigalimab moves through the body in adult Chinese participants ...

4. researchgate.net researchgate.net/publication/381979970_Phase_23_study_of_livmoniplimab_in_combination_with_budigalimab_in_patients_with_locally_advanced_or_metastatic_hepatocellular_carcinoma

Phase 2/3 study of livmoniplimab in combination with ... A phase 1 study in HCC showed an overall response rate (ORR) of 42% (5/12) when combining livmoniplimab with the programmed cell death 1 ...

5. onclive.com onclive.com/view/budigalimab-plus-abbv-151-demonstrates-variable-activity-across-locally-advanced-or-metastatic-solid-tumors

Budigalimab Plus ABBV-151 Demonstrates Variable ... The addition of budigalimab to ABBV-151 was well tolerated and significantly enhanced responses in patients with locally advanced or metastatic solid tumors.