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) (LIVIGNO-1)

• ClinicalTrials.gov Identifier: NCT05822752
• Recruitment Status: Recruiting
• First Posted: April 21, 2023
• Last Update Posted: May 10, 2024
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: April 10, 2023
• First Posted Date: April 21, 2023
• Last Update Posted Date: May 10, 2024
• Actual Study Start Date: September 21, 2023
• Estimated Primary Completion Date: December 23, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 27, 2023)

Best Overall Response (BOR) per Investigator [ Time Frame: Through Study Completion, Up to Approximately 27 Months ]

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.

Original Primary Outcome Measures (submitted: April 10, 2023)

Best Overall Response (BOR) per Investigator [ Time Frame: Through Study Completion, Up to Approximately 27 Months ]

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 antineoplastic therapy.

Current Secondary Outcome Measures (submitted: April 10, 2023)

• Duration of response (DOR) per Investigator [ Time Frame: Through Study Completion, Up to Approximately 27 Months ]
  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.
• Number of Participants with Progression-free Survival (PFS) [ Time Frame: Through Study Completion, Up to Approximately 27 Months ]
  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.
• Overall Survival (OS) [ Time Frame: Through Study Completion, Up to Approximately 27 Months ]
  OS is defined as the time from randomization until death from any cause.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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

Brief 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. 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.

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hepatocellular Carcinoma

Intervention

• Drug: Budigalimab
  Intravenous (IV) Infusion
  Other Name: ABBV-181
• Drug: Livmoniplimab
  Intravenous (IV) Infusion
  Other Name: ABBV-151
• Drug: Lenvatinib
  Oral: Capsule
• Drug: Sorafenib
  Oral: Tablet

Study Arms

• Active Comparator: Arm 1: Lenvatinib or Sorafenib
  Participants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period.
  Interventions:

  • Drug: Lenvatinib
  • Drug: Sorafenib
• Experimental: Arm 2: Livmoniplimab Dose A + Budigalimab
  Participants will receive Livmoniplimab Dose A in combination with budigalimab, as part of an approximately 2 year treatment period.
  Interventions:

  • Drug: Budigalimab
  • Drug: Livmoniplimab
• Experimental: Arm 3: Livmoniplimab Dose B + Budigalimab
  Participants will receive Livmoniplimab Dose B in combination with budigalimab, as part of an approximately 2 year treatment period.
  Interventions:

  • Drug: Budigalimab
  • Drug: Livmoniplimab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 10, 2023): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 16, 2027
• Estimated Primary Completion Date: December 23, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: ABBVIE CALL CENTER; 844-663-3742; abbvieclinicaltrials@abbvie.com

• Listed Location Countries: France, Italy, Japan, Korea, Republic of, Spain, Taiwan, United States

Administrative Information

• NCT Number: NCT05822752
• Other Study ID Numbers: M24-147; 2022-502948-13-00 ( Other Identifier: EU CT )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• URL: https://vivli.org/ourmember/abbvie/

• Current Responsible Party: AbbVie
• Original Responsible Party: Same as current
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: May 2024