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A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab

Study acronym: IMbrave251
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jun 30, 2026 → Oct 14, 2026
See other at-risk trials from Roche/Genentech

Record History

The 50 most recent of 56 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jun 30, 2026 to Oct 14, 2026 Study sites: 123 to 124v56 Show 1 more changeShow less
    • Study sites: 123 to 124
  2. Study sites revised (123)v55 See this version in full on ClinicalTrials.gov ↗
  3. Primary completion date: Mar 31, 2026 to Jun 30, 2026 Study sites revised (123)v54 Show 1 more changeShow less
    • Study sites revised (123)

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Sep 26, 2025 to Mar 31, 2026 Completion date: Oct 17, 2025 to Jun 30, 2026 · Site details revised at 1 of 123 sitesv53 Show 2 more changesShow less
    • Completion date: Oct 17, 2025 to Jun 30, 2026
    • Site details revised at 1 of 123 sites
  5. Enrollment target: estimated 554 to confirmed 557 Study sites: 122 to 123 · Primary completion date: Jul 31, 2025 to Sep 26, 2025v52 Show 2 more changesShow less
    • Study sites: 122 to 123
    • Primary completion date: Jul 31, 2025 to Sep 26, 2025
Show 45 earlier versionsHide 45 earlier versions
  1. Primary completion date: Jul 9, 2025 to Jul 31, 2025v51
  2. Study sites: 125 to 122v50
  3. Study sites: 126 to 125 Completion date: Jul 9, 2025 to Oct 17, 2025v49 Show 1 more changeShow less
    • Completion date: Jul 9, 2025 to Oct 17, 2025
  4. Study sites: 134 to 126v48
  5. Trial status: Recruiting to Active, Not Recruiting Study sites: 167 to 134v47 Show 1 more changeShow less
    • Study sites: 167 to 134
  6. Trial status: Active, Not Recruiting to Recruiting Study sites: 139 to 167v46 Show 1 more changeShow less
    • Study sites: 139 to 167
  7. Primary completion date: Sep 23, 2024 to Jul 9, 2025 Trial status: Recruiting to Active, Not Recruiting · Study sites: 164 to 139 · Completion date: Mar 31, 2025 to Jul 9, 2025v45 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 164 to 139
    • Completion date: Mar 31, 2025 to Jul 9, 2025
  8. Completion date: Sep 23, 2024 to Mar 31, 2025 Secondary endpoints revised (9) · Site details revised at 16 of 164 sitesv44 Show 2 more changesShow less
    • Secondary endpoints revised (9)
    • Site details revised at 16 of 164 sites

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 162 to 164v43
  10. Study sites: 160 to 162v42
  11. Site details revised at 19 of 160 sitesv41
  12. Study sites: 159 to 160v40
  13. Study sites: 158 to 159v39
  14. Site details revised at 7 of 158 sitesv38
  15. Study sites: 157 to 158v37
  16. Study sites: 155 to 157v36
  17. Study sites: 154 to 155v35
  18. Study sites: 152 to 154v34
  19. Study sites: 149 to 152 Primary and study completion dates: Feb 5, 2025 to Sep 23, 2024v33 Show 1 more changeShow less
    • Primary and study completion dates: Feb 5, 2025 to Sep 23, 2024
  20. Study sites: 147 to 149v32
  21. Study sites: 145 to 147v31
  22. Study sites: 144 to 145v30
  23. Study sites: 140 to 144v29
  24. Study sites: 138 to 140v28
  25. Study sites: 130 to 138v27
  26. Study sites: 129 to 130 Primary and study completion dates: Oct 8, 2024 to Feb 5, 2025v26 Show 1 more changeShow less
    • Primary and study completion dates: Oct 8, 2024 to Feb 5, 2025
  27. Study sites: 125 to 129v25
  28. Re-verified, no change to tracked fieldsv24
  29. Site details revised at 3 of 125 sitesv23
  30. Study sites: 123 to 125v22
  31. Study sites: 122 to 123v21
  32. Study sites: 118 to 122v20
  33. Study sites: 111 to 118v19
  34. Study sites: 105 to 111v18
  35. Study sites: 104 to 105 Eligibility criteria expanded, about 18 words · Secondary endpoints: details revised at 2 of 9 entriesv17 Show 2 more changesShow less
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 2 of 9 entries

    See this version in full on ClinicalTrials.gov ↗

  36. Study sites: 94 to 104v16
  37. Study sites: 88 to 94v15
  38. Study sites: 80 to 88v14
  39. Study sites: 69 to 80v13
  40. Study sites: 129 to 69v12
  41. Study sites: 127 to 129v11
  42. Study sites: 128 to 127v10
  43. Study sites: 116 to 128v9
  44. Study sites: 109 to 116v8
  45. Study sites: 105 to 109v7
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
Roche/Genentech
366 trials monitored
See 33 trials at risk
Liver Cancer
1,512 trials monitored
See 63 trials at risk
This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination.
Trial Details
NCT Number NCT04770896
Lead Sponsor Hoffmann-La Roche
Conditions Unresectable Hepatocellular Carcinoma
Enrollment 557 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov