AzTrials
AzTrials

Hepatocellular CarcinomaPhase 2/3LIVIGNO-2NCT06109272

A Study to Assess the Dose, Adverse Events, and Change in Disease Activity of Livmoniplimab as an Intravenous (IV) Solution in Combination With Budigalimab as an IV Solution in Adult Participants With Hepatocellular Carcinoma (HCC)

A Phase 2/3 study testing Livmoniplimab, Budigalimab and Durvalumab in people with Hepatocellular Carcinoma, run by AbbVie at 37 sites in 6 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?
Livmoniplimab, Budigalimab and Durvalumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
37 sitesin 6 countries
Study dates
11 Jan 2024to Jan 2027
Phase
Phase 2/3
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

  • Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology or cytology or clinically by American Association for the Study of Liver Diseases criteria for participants with cirrhosis.
  • Barcelona Clinic Liver Cancer (BCLC) Stage B or C.
  • Child-Pugh A or B7 classification (i.e., total Child-Pugh score of 5, 6, or 7).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

Who cannot join

  • Prior systemic therapy for HCC.
  • Symptomatic, untreated, or actively progressing CNS metastases.
  • History of malignancy other than HCC.

Trial locations and contacts

37 sites in 6 countries.

37 sites in 6 countries

United States13 sites

  • Texas Oncology - Abilene - Antilley Road /ID# 265820

    Abilene, Texas, 79606

  • The University of Chicago Medical Center /ID# 255674

    Chicago, Illinois, 60637-1443

  • Texas Oncology - Dallas - Worth Street /ID# 265806

    Dallas, Texas, 75246

  • Baylor Scott and White Research Institute /ID# 260853

    Dallas, Texas, 76508-0001

  • Henry Ford Hospital - Detroit /ID# 255803

    Detroit, Michigan, 48202

  • City of Hope /ID# 261468

    Duarte, California, 91010

  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 261669

    Irvine, California, 92618

  • Norton Cancer Institute /ID# 260775

    Louisville, Kentucky, 40217-1395

  • Alliance for Multispecialty Research LLC Kansas City Oncology /ID# 256830

    Merriam, Kansas, 66204

  • UC Irvine /ID# 255673

    Orange, California, 92868

  • Oncology and Hematology Associates of Southwest Virginia /ID# 265834

    Roanoke, Virginia, 98684

  • Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 256041

    Saint Louis Park, Minnesota, 55416

  • Washington University-School of Medicine /ID# 255720

    St Louis, Missouri, 63110

Other trials in United States

Italy7 sites

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 256412

    Bologna, 40138

  • IRCCS Ospedale San Raffaele /ID# 256404

    Milan, Milano, 20132

  • P.O. Ospedale del Mare /ID# 256410

    Naples, Napoli, 80147

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 256681

    Palermo, 90127

  • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 256895

    Roma, 00128

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 265506

    Rome, Roma, 00168

  • IRCCS Istituto Clinico Humanitas /ID# 256684

    Rozzano, Lombardy, 20089

Other trials in Italy

Spain7 sites

  • Hospital Universitario Vall de Hebron /ID# 255771

    Barcelona, 08035

  • Hospital Universitario Reina Sofia /ID# 255779

    Córdoba, 14004

  • Hospital General Universitario Gregorio Maranon /ID# 255772

    Madrid, 28007

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 255778

    Majadahonda, Madrid, 28222

  • Hospital Universitario Marques de Valdecilla /ID# 255769

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocio /ID# 255776

    Seville, 41013

  • Hospital Universitario Miguel Servet /ID# 255774

    Zaragoza, 50009

Other trials in Spain

Taiwan5 sites

  • China Medical University Hospital /ID# 256764

    Taichung, 40447

  • Taichung Veterans General Hospital /ID# 259405

    Taichung, 40705

  • National Cheng Kung University Hospital /ID# 256766

    Tainan, 704

  • National Taiwan University Hospital /ID# 256168

    Taipei, 100

  • Taipei Veterans General Hosp /ID# 256169

    Taipei, 11217

Other trials in Taiwan

France4 sites

  • Hopital Avicenne /ID# 266005

    Bobigny, Île-de-France Region, 93000

  • Hopital Beaujon /ID# 256551

    Clichy, Île-de-France Region, 92110

  • CHU Grenoble - Hopital Michallon /ID# 256627

    La Tronche, Isere, 38700

  • Institut Gustave Roussy /ID# 258460

    Villejuif, Val-de-Marne, 94805

Other trials in France

Puerto Rico1 site

  • Puerto Rico Medical Research Center /ID# 262362

    Hato Rey, Puerto Rico, 00917

Other trials in Puerto Rico

About this study

Official title: A Phase 2/3, Randomized Study to Evaluate the Dose Optimization, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab in Subjects With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Treatment

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 2 stages to this study. In Stage 1, there are 3 treatment arms 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), atezolizumab in combination with bevacizumab, or tremelimumab in combination with durvalumab. In Stage 2, there are 2 treatments arms and participants will be randomized in a 1:1 ratio. Participants will either receive livmoniplimab (optimized dose) in combination with budigalimab or tremelimumab in combination with durvalumab. Approximately 660 adult participants will be enrolled in the study across 185 sites worldwide.

Read more

Stage 1: In arm 1, participants will receive intravenously (IV) infused livmoniplimab (Dose 1) in combination with IV infused budigalimab, every 3 weeks. In arm 2, participants will receive IV infused livmoniplimab (Dose 2) in combination with IV infused budigalimab, every 3 weeks. In Arm 3 (control), participants will receive the investigator's choice: IV atezolizumab in combination with IV bevacizumab every 3 weeks or single dose IV tremelimumab in combination with IV durvalumab every 4 weeks. Stage 2: In arm 1, participants will receive IV infused livmoniplimab (optimized dose) in combination with IV infused budigalimab, every 3 weeks. In Arm 2 (control), participants will receive single dose IV tremelimumab in combination with IV durvalumab every 4 weeks. All participants will continue treatment until disease progression or discontinuation criteria are met, whichever occurs first. The estimated duration of this study is about 56 months.

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
Livmoniplimab, Budigalimab, Durvalumab, Atezolizumab, Bevacizumab
Keywords
Hepatocellular Carcinoma, Livmoniplimab, ABBV-151, budigalimab, ABBV-181
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • LivmoniplimabDrug

    Also called ABBV-151

    Intravenous (IV) Solution

  • BudigalimabDrug

    Also called ABBV-181

    Intravenous (IV) Solution

  • DurvalumabDrug

    Intravenous (IV) Solution

  • AtezolizumabDrug

    Intravenous (IV) Solution

  • BevacizumabDrug

    Intravenous (IV) Solution

  • TremelimumabDrug

    Intravenous (IV) Solution

Study groups in NCT06109272
Study groupRoleWhat they receive
Stage 1: Cohort 1ExperimentalParticipants will receive livmoniplimab Dose 1 in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met.
Receives: Drug: Livmoniplimab; Drug: Budigalimab
Stage 1: Cohort 2ExperimentalParticipants will receive livmoniplimab Dose 2 in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met.
Receives: Drug: Livmoniplimab; Drug: Budigalimab
Stage 1: Cohort 3 - Group 1 (Control)Active comparatorParticipants will receive atezolizumab in combination with bevacizumab every 3 weeks until disease progression or until discontinuation criteria are met.
Receives: Drug: Atezolizumab; Drug: Bevacizumab
Stage 1: Cohort 3 - Group 2 (Control)Active comparatorParticipants will receive a single dose of tremelimumab in combination with durvalumab every four weeks until disease progression or until discontinuation criteria are met.
Receives: Drug: Durvalumab; Drug: Tremelimumab
Stage 2: Arm 1ExperimentalParticipants will receive livmoniplimab (optimized dose) in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met.
Receives: Drug: Livmoniplimab; Drug: Budigalimab
Stage 2: Arm 2 (Control)Active comparatorParticipants will receive a single dose of tremelimumab in combination with durvalumab every 4 weeks until disease progression or until discontinuation criteria are met.
Receives: Drug: Durvalumab; Drug: Tremelimumab

What is being measured

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

  1. Stage 1: Best Overall Response (BOR) per Investigator

    BOR is defined as a participant 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 56 Months

  2. Stage 2: Overall Survival (OS)

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

    Measured: Through Study Completion, Up to Approximately 56 Months

Secondary outcomes (13)

  1. Stage 1: 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 56 Months

  2. Stage 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 56 Months

  3. Stage 1: Overall Survival (OS)

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

    Measured: Through Study Completion, Up to Approximately 56 Months

  4. Stage 1: Number of Participants with Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Through Study Completion, Up to Approximately 56 Months

  5. Stage 1: Maximum Plasma Concentration (Cmax) of Livmoniplimab and Budigalimab

    Cmax of livmoniplimab and budigalimab.

    Measured: Through Study Completion, Up to Approximately 56 Months

  6. Stage 1: Time to Cmax (Tmax) of Livmoniplimab and Budigalimab

    Tmax of livmoniplimab and budigalimab.

    Measured: Through Study Completion, Up to Approximately 56 Months

  7. Stage 1: Area Under the Serum Concentration Versus Time Curve (AUC) of Livmoniplimab and Budigalimab

    AUC of livmoniplimab and budigalimab.

    Measured: Through Study Completion, Up to Approximately 56 Months

  8. Stage 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 blinded independent central review (BICR) or death from any cause, whichever occurs first.

    Measured: Through Study Completion, Up to Approximately 56 Months

  9. Stage 2: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) per BICR

    BOR is defined as a participant achieving confirmed CR/PR per RECIST 1.1 as determined by BICR at any time prior to subsequent anticancer therapy.

    Measured: Through Study Completion, Up to Approximately 56 Months

  10. Change from Baseline in the Pain Domain of the European Organization for Research Treatment of Cancer Quality of Life Questionnaire Hepatocellular Carcinoma 18-Question Module (EORTC QLQ-HCC18)

    The EORTC QLQ-HCC18 is an 18-item scale that measures hepatocellular carcinoma (HCC)-specific symptoms and health-related quality of life (HRQoL). The Pain Domain contains 2 items where scores are based on a 4-point Likert scale (with 1 = 'not at all' to 4 = 'very much'); scaled scores for each domain ranged from 0-100 with a higher score indicating worse symptoms.

    Measured: Baseline to Week 12

  11. Change from Baseline in the Fatigue Domain of the EORTC QLQ-HCC18

    The EORTC QLQ-HCC18 is an 18-item scale that measures HCC-specific symptoms and HRQoL. The Fatigue Domain contains 3 items where scores are based on a 4-point Likert scale (with 1 = 'not at all' to 4 = 'very much'); scaled scores for each domain ranged from 0-100 with a higher score indicating worse symptoms.

    Measured: Baseline to Week 12

  12. Change from Baseline in Physical Function (PF) Domain of the European Organization for Research Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)

    The EORTC QLQ-C30 is an 30-item patient-reported questionnaire that measures symptoms and HRQoL. The PF Domain is a functional scale where participants rate items on a 4-point scale (with 1 = 'not at all' to 4 = 'very much'). A change of 5 to 10 points is considered a small change and the lower bound (5) will be used to define the minimum important difference. A change of >= 10 to < 20 points is considered a moderate change.

    Measured: Baseline to Week 12

  13. Change from Baseline in Global Health Status (GHS)/Quality of Life (QoL) Domain as Measured by the GHS/QoL Domain of the EORTC QLQ-C30

    The EORTC QLQ-C30 is an 30-item patient-reported questionnaire that measures symptoms and HRQoL. The GHS/QoL Domain is a scale where participants rate items on a 4-point scale (with 1 = 'not at all' to 4 = 'very much'). A change of 5 to 10 points is considered a small change and the lower bound (5) will be used to define the minimum important difference. A change of ≥ 10 to < 20 points is considered a moderate change.

    Measured: Baseline to Week 12

Timeline

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

  1. First posted31 Oct 2023
  2. Study start11 Jan 2024
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06109272
Sponsor's protocol ID
M24-052
Other IDs
2023-504600-28-00, 2023
Acronym
LIVIGNO-2
Status last verified
Sep 2026
First submitted
26 Oct 2023
Last updated
22 Sep 2026
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 2/3 study testing Livmoniplimab, Budigalimab and Durvalumab in people with Hepatocellular Carcinoma, run by AbbVie at 37 sites in 6 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 4 inclusion and 3 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Italy, Spain, Taiwan, France and 1 more country. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Stage 1: Best Overall Response (BOR) per Investigator (time frame: Through Study Completion, Up to Approximately 56 Months). The study lists 2 primary outcomes in all. 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 NCT06109272.

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 22 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in