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)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05822752 |
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Recruitment Status :
Recruiting
First Posted : April 21, 2023
Last Update Posted : May 2, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatocellular Carcinoma | Drug: Budigalimab Drug: Livmoniplimab Drug: Lenvatinib Drug: Sorafenib | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | September 21, 2023 |
| Estimated Primary Completion Date : | December 23, 2026 |
| Estimated Study Completion Date : | February 16, 2027 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm 1: Lenvatinib or Sorafenib
Participants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period.
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Drug: Lenvatinib
Oral: Capsule Drug: Sorafenib Oral: Tablet |
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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.
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Drug: Budigalimab
Intravenous (IV) Infusion
Other Name: ABBV-181 Drug: Livmoniplimab Intravenous (IV) Infusion
Other Name: ABBV-151 |
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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.
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Drug: Budigalimab
Intravenous (IV) Infusion
Other Name: ABBV-181 Drug: Livmoniplimab Intravenous (IV) Infusion
Other Name: ABBV-151 |
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05822752
| Contact: ABBVIE CALL CENTER | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
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| Study Director: | ABBVIE INC. | AbbVie |
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT05822752 |
| Other Study ID Numbers: |
M24-147 2022-502948-13-00 ( Other Identifier: EU CT ) |
| First Posted: | April 21, 2023 Key Record Dates |
| Last Update Posted: | May 2, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (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 Statistical Analysis Plan (SAP) 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/ |
| 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 |
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Hepatocellular Carcinoma Lenvatinib Sorafenib Livmoniplimab |
Budigalimab ABBV-181 ABBV-151 Cancer |
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Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Liver Diseases Sorafenib Lenvatinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |