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)

Study acronym: LIVIGNO-2
StatusActive, Not Recruiting
PhasePhase 2/3
SponsorAbbVie
Started

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Record History

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  1. Primary and study completion moved earlier from Sep 2030 to Jan 2027 Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Final enrollment: 89 participants (planned 660)
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 5 of 13 entries
    • Study sites revised (37)
  2. Trial status: Active, Not Recruiting to Recruiting
    • Study sites revised (37)
    v40
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 37 of 37 sites
    v39
  4. Site details revised at 2 of 37 sitesv38
  5. Study sites: 36 to 37
    • Primary and study completion dates: Sep 6, 2030 to Sep 2030
    v37
Show 35 earlier versionsHide 35 earlier versions
  1. Study sites: 35 to 36v36
  2. Study sites: 33 to 35v35
  3. Study sites: 32 to 33v34
  4. Study sites: 31 to 32v33
  5. Study sites revised (31)v32
  6. Study sites: 30 to 31v31
  7. Site details revised at 4 of 30 sitesv30
  8. Study sites: 28 to 30v29
  9. Re-verified, no change to tracked fieldsv28
  10. Study sites: 27 to 28v27
  11. Study sites: 25 to 27v26
  12. Study sites: 24 to 25v25
  13. Study sites: 23 to 24v24
  14. Study sites: 22 to 23v23
  15. Study sites: 21 to 22v22
  16. Study sites: 20 to 21v21
  17. Study sites: 18 to 20v20
  18. Study sites: 16 to 18v19
  19. Study sites: 15 to 16v18
  20. Re-verified, no change to tracked fieldsv17
  21. Study sites: 13 to 15v16
  22. Re-verified, no change to tracked fieldsv15
  23. Study sites: 11 to 13v14
  24. Study sites: 10 to 11v13
  25. Study sites: 9 to 10v12
  26. Study sites: 8 to 9v11
  27. Study sites: 7 to 8v10
  28. Study sites: 6 to 7
    • Primary and study completion dates: Sep 13, 2030 to Sep 6, 2030
    v9
  29. Study sites: 5 to 6v8
  30. Study sites: 4 to 5v7
  31. Study sites: 3 to 4v6
  32. Start date changed from estimate of Feb 12, 2024 to Jan 11, 2024
    • Study sites revised (3)
    v5
  33. Study sites: 2 to 3
    • Primary completion date: Jun 29, 2030 to Sep 13, 2030
    • Start date: Jan 16, 2024 to Feb 12, 2024
    v4
  34. Study sites: 1 to 2v3
  35. Phase: Phase 2 to Phase 2/3
    • Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Study completion date: Jun 29, 2030 to Sep 13, 2030
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AbbVie
349 trials monitored
See 27 trials at risk
Liver Cancer
1,602 trials monitored
See 70 trials at risk
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. 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.
Trial Details
NCT Number NCT06109272
Lead Sponsor AbbVie
Conditions
(from sponsor)		 Hepatocellular Carcinoma
Related terms Carcinoma, Hepatocellular
Enrollment 89 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov