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Hepatocellular CarcinomaPhase 2LIVIGNO-1NCT05822752

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)

A Phase 2 study testing Budigalimab, Livmoniplimab and Lenvatinib in people with Hepatocellular Carcinoma, run by AbbVie at 59 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Hepatocellular carcinoma (HCC) is a common cancer worldwide and a leading cause of cancer-related death. The majority of participants first presenting with HCC have advanced unresectable or metastatic disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Budigalimab, Livmoniplimab and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
59 sitesin 7 countries
Study dates
21 Sep 2023to Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Child-Pugh A classification.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  • Received an immune checkpoint inhibitor in first-line (1L) hepatocellular carcinoma (HCC) treatment regimen.
  • Adequate hematologic and end-organ function.
  • Tissue biopsy at screening.
  • Disease that is not amenable to surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies.

Who cannot join

  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
  • Prior treatment with an approved tyrosine kinase inhibitor (for example sorafenib or Lenvatinib) in 1L HCC treatment regimen.
  • History of malignancy other than hepatocellular carcinoma (HCC) within 5 years prior to screening.
  • Hepatic encephalopathy or requirement for medications to prevent or control encephalopathy.
  • Moderate or severe ascites requiring recurrent non-pharmacologic intervention to maintain symptomatic control.
  • Coinfection with active HBV infection and active HCV infection.
  • Prior history of grade 3 or higher immune-mediated adverse event or discontinuation due to immune-mediated adverse events.
  • Prior history of recurrent grade 2 or higher interstitial lung disease/pneumonitis.

Trial locations and contacts

59 sites in 7 countries.

59 sites in 7 countries

United States20 sites

  • Messino Cancer Center - Asheville /ID# 253888

    Asheville, North Carolina, 28806-2316

  • Hematology/Oncology Clinic /ID# 253851

    Baton Rouge, Louisiana, 70809

  • Dana-Farber Cancer Institute /ID# 252696

    Boston, Massachusetts, 02215

  • University of North Carolina /ID# 252739

    Chapel Hill, North Carolina, 27514

  • The University of Chicago Medical Center /ID# 252870

    Chicago, Illinois, 60637-1443

  • Duplicate_Texas Oncology - Medical City Dallas /ID# 254164

    Dallas, Texas, 75230

  • Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 252770

    Dallas, Texas, 75246-2003

  • Rocky Mountain Cancer Centers - Denver Midtwon /ID# 254163

    Denver, Colorado, 80218

  • Henry Ford Hospital /ID# 253342

    Detroit, Michigan, 48202

  • University of California, Los Angeles /ID# 253292

    Los Angeles, California, 90095

  • NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 252708

    New York, New York, 10016-4744

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252705

    New York, New York, 10065-6007

  • UC Irvine /ID# 252707

    Orange, California, 92868

  • AdventHealth Orlando /ID# 252865

    Orlando, Florida, 32803

  • Arizona Oncology Associates, PC - NAHOA Prescott Valley /ID# 254313

    Prescott Valley, Arizona, 86314

  • Lifespan Cancer Institute at Rhode Island Hospital /ID# 252699

    Providence, Rhode Island, 02903-4923

  • California Pacific Medical Center - San Francisco - Webster Street /ID# 253291

    San Francisco, California, 94115

  • Highlands Oncology Group, PA /ID# 253158

    Springdale, Arkansas, 72762

  • Washington University-School of Medicine /ID# 252698

    St Louis, Missouri, 63110

  • Texas Oncology - Northeast Texas /ID# 254184

    Tyler, Texas, 75702

Other trials in United States

Taiwan9 sites

  • E-DA Cancer Hospital /ID# 260881

    Kaohsiung City, Kaohsiung, 82445

  • Kaohsiung Chang Gung Memorial Hospital /ID# 253675

    Kaohsiung City, Kaohsiung, 833

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 253451

    Kaohsiung City, 807

  • China Medical University Hospital /ID# 253453

    Taichung, 40447

  • Taichung Veterans General Hospital /ID# 253452

    Taichung, 40705

  • National Cheng Kung University Hospital /ID# 253676

    Tainan, 704

  • Taipei Veterans General Hosp /ID# 253450

    Taipei, 11217

  • National Taiwan University Hospital /ID# 253449

    Taipei City, Taipei, 100

  • Linkou Chang Gung Memorial Hospital /ID# 253674

    Taoyuan City, 333

Other trials in Taiwan

Spain8 sites

  • Hospital Universitario Vall d'Hebron /ID# 253063

    Barcelona, 08035

  • Hospital Universitario Reina Sofia /ID# 253083

    Córdoba, Cordoba, 14004

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 254840

    Madrid, 28027

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253078

    Majadahonda, Madrid, 28222

  • Clinica Universidad de Navarra - Pamplona /ID# 253073

    Pamplona, Navarre, 31008

  • Hospital Universitario Marques de Valdecilla /ID# 253059

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocio /ID# 253074

    Seville, 41013

  • Hospital Universitario Miguel Servet /ID# 253071

    Zaragoza, 50009

Other trials in Spain

France6 sites

  • Hopital Beaujon /ID# 252758

    Clichy, Île-de-France Region, 92110

  • CHU Grenoble - Hopital Michallon /ID# 252755

    La Tronche, Isere, 38700

  • CHRU Lille - Hopital Claude Huriez /ID# 252748

    Lille, Nord, 59037

  • CHU Montpellier - Hopital Saint Eloi /ID# 252760

    Montpellier, Herault, 34295

  • Centre Hospitalier Universitaire de Bordeaux /ID# 252749

    Pessac, Gironde, 33604

  • AP-HP - Hopital Paul-Brousse /ID# 253646

    Villejuif, 94800

Other trials in France

Italy6 sites

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 253247

    Bologna, 40138

  • Azienda Ospedaliero Universitaria Careggi /ID# 254444

    Florence, Firenze, 50134

  • IRCCS Ospedale San Raffaele /ID# 252910

    Milan, Milano, 20132

  • P.O. Ospedale del Mare /ID# 253140

    Naples, Napoli, 80147

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 253142

    Palermo, 90127

  • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 253141

    Roma, 00128

Other trials in Italy

Japan5 sites

  • Chiba University Hospital /ID# 255190

    Chiba, Chiba, 260-8677

  • Kanazawa University Hospital /ID# 254861

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East /ID# 253419

    Kashiwa-shi, Chiba, 277-8577

  • Kindai University Hospital /ID# 255106

    Osakasayama-shi, Osaka, 589-8511

  • Yokohama City University Medical Center /ID# 255790

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

South Korea5 sites

  • Chonnam National University Hwasun Hospital /ID# 253133

    Hwasun-gun, Jeonranamdo, 58128

  • CHA Bundang Medical Center /ID# 253054

    Seongnam, Gyeonggido, 13496

  • Seoul National University Bundang Hospital /ID# 253412

    Seongnam-si, Gyeonggido, 13620

  • Asan Medical Center /ID# 253044

    Seoul, Seoul Teugbyeolsi, 05505

  • Samsung Medical Center /ID# 253411

    Seoul, Seoul Teugbyeolsi, 06351

Other trials in South Korea

About this study

Official title: A Phase 2, Randomized Study to Evaluate the Optimized Dose, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab for Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Patients Who Have Progressed After an Immune Checkpoint Inhibitor Containing Regimen in First-Line HCC

Hepatocellular carcinoma (HCC) is a common cancer worldwide and a leading cause of cancer-related death. The majority of participants first presenting with HCC have advanced unresectable or metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab.

Livmoniplimab is an investigational drug being developed for the treatment of HCC. There are 3 treatment arms in this study and participants will be randomized in a 1:1:1 ratio. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug), lenvatinib, or sorafenib. Approximately 120 adult participants will be enrolled in the study across 60 sites worldwide.

Read more

In arm 1 (control), participants will receive the investigator's choice: lenvatinib as an oral capsule or sorafenib as an oral tablet, once daily. In arm 2, participants will receive intravenously (IV) infused livmoniplimab (dose A) in combination with IV infused budigalimab, every 3 weeks. In arm 3, participants will receive intravenously (IV) infused livmoniplimab (dose B) in combination with IV infused budigalimab, every 3 weeks. The estimated duration of the study is up to 2 years

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.

Being tested
Budigalimab, Livmoniplimab, Lenvatinib, Sorafenib
Keywords
Hepatocellular Carcinoma, Lenvatinib, Sorafenib, Livmoniplimab, Budigalimab, ABBV-181, ABBV-151, Cancer
Medical subject headings
Carcinoma, Hepatocellular, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BudigalimabDrug

    Also called ABBV-181

    Intravenous (IV) Infusion

  • LivmoniplimabDrug

    Also called ABBV-151

    Intravenous (IV) Infusion

  • LenvatinibDrug

    Oral: Capsule

  • SorafenibDrug

    Oral: Tablet

Study groups in NCT05822752
Study groupRoleWhat they receive
Arm 1: Lenvatinib or SorafenibActive comparatorParticipants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period.
Receives: Drug: Lenvatinib; Drug: Sorafenib
Arm 2: Livmoniplimab Dose A + BudigalimabExperimentalParticipants will receive Livmoniplimab Dose A in combination with budigalimab, as part of an approximately 2 year treatment period.
Receives: Drug: Budigalimab; Drug: Livmoniplimab
Arm 3: Livmoniplimab Dose B + BudigalimabExperimentalParticipants will receive Livmoniplimab Dose B in combination with budigalimab, as part of an approximately 2 year treatment period.
Receives: Drug: Budigalimab; Drug: Livmoniplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best Overall Response (BOR) per Investigator

    BOR is defined as a subject achieving confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by investigators at any time prior to subsequent anticancer therapy.

    Measured: Through Study Completion, Up to Approximately 27 Months

Secondary outcomes (3)

  1. Duration of response (DOR) per Investigator

    DOR is defined as the time from first confirmed CR or PR until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.

    Measured: Through Study Completion, Up to Approximately 27 Months

  2. Number of Participants with Progression-free Survival (PFS)

    PFS is defined as the time from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.

    Measured: Through Study Completion, Up to Approximately 27 Months

  3. Overall Survival (OS)

    OS is defined as the time from randomization until death from any cause.

    Measured: Through Study Completion, Up to Approximately 27 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2023
  2. Study start21 Sep 2023
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05822752
Sponsor's protocol ID
M24-147
Other IDs
2022-502948-13-00
Acronym
LIVIGNO-1
Status last verified
Aug 2025
First submitted
10 Apr 2023
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Budigalimab, Livmoniplimab and Lenvatinib in people with Hepatocellular Carcinoma, run by AbbVie at 59 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Taiwan, Spain, France, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Overall Response (BOR) per Investigator (time frame: Through Study Completion, Up to Approximately 27 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05822752.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.

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