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Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy

Study acronym: COSMIC-312
StatusActive, Not Recruiting
PhasePhase 3
SponsorExelixis
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results first posted: Dec 11, 2025 Primary completion date: Mar 8, 2021 to Nov 30, 2021 · Secondary endpoints: details revised at 1 of 1 entryv46 Show 2 more changesShow less
    • Primary completion date: Mar 8, 2021 to Nov 30, 2021
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Primary endpoints revised (2) Completion date: Dec 1, 2024 to Jul 31, 2026 · Eligibility criteria expanded, about 36 words · Secondary endpoint revised · 1 morev45 Show 4 more changesShow less
    • Completion date: Dec 1, 2024 to Jul 31, 2026
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoint revised
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Completion date: Dec 1, 2023 to Dec 1, 2024 Site details revised at 1 of 245 sites · Eligibility criteria shortened, about 2 wordsv44 Show 2 more changesShow less
    • Site details revised at 1 of 245 sites
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 740 to confirmed 837 · Study sites: 246 to 245v43 Show 2 more changesShow less
    • Enrollment target: estimated 740 to confirmed 837
    • Study sites: 246 to 245
  5. Site details revised at 111 of 246 sitesv42
Show 40 earlier versionsHide 40 earlier versions
  1. Study sites: 242 to 246v41
  2. Re-verified, no change to tracked fieldsv40
  3. Study sites: 237 to 242 Primary completion date changed from estimate of Jun 1, 2021 to Mar 8, 2021 · Completion date: Dec 1, 2021 to Dec 1, 2023 · Start date: Dec 10, 2018 to Jun 10, 2018v39 Show 3 more changesShow less
    • Primary completion date changed from estimate of Jun 1, 2021 to Mar 8, 2021
    • Completion date: Dec 1, 2021 to Dec 1, 2023
    • Start date: Dec 10, 2018 to Jun 10, 2018
  4. Study sites: 234 to 237v38
  5. Study sites: 233 to 234v37
  6. Study sites: 229 to 233v36
  7. Study sites: 227 to 229v35
  8. Primary completion date: Aug 1, 2020 to Jun 1, 2021 Study sites: 222 to 227v34 Show 1 more changeShow less
    • Study sites: 222 to 227
  9. Study sites: 218 to 222v33
  10. Site details revised at 14 of 218 sitesv32
  11. Study sites: 209 to 218v31
  12. Study sites: 200 to 209v30
  13. Study sites: 192 to 200v29
  14. Study sites: 185 to 192v28
  15. Study sites: 183 to 185v27
  16. Study sites: 147 to 183v26
  17. Study sites: 142 to 147v25
  18. Study sites: 137 to 142v24
  19. Study sites: 128 to 137v23
  20. Study sites: 80 to 128v22
  21. Study sites: 65 to 80v21
  22. Study sites: 61 to 65v20
  23. Study sites: 58 to 61v19
  24. Study sites: 56 to 58v18
  25. Study sites: 53 to 56v17
  26. Study sites: 49 to 53v16
  27. Study sites: 27 to 49v15
  28. Study sites: 16 to 27v14
  29. Primary endpoints revised (2) Enrollment target: 640 to 740 · Study sites: 15 to 16 · Eligibility criteria expanded, about 21 words · 2 morev13 Show 5 more changesShow less
    • Enrollment target: 640 to 740
    • Study sites: 15 to 16
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoint revised
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  30. Study sites: 10 to 15v12
  31. Site details revised at 1 of 10 sitesv11
  32. Study sites: 8 to 10v10
  33. Study sites: 7 to 8v9
  34. Site details revised at 1 of 7 sitesv8
  35. Study sites: 5 to 7v7
  36. Study sites: 4 to 5v6
  37. Study sites: 3 to 4v5
  38. Study sites: 2 to 3 Start date changed from estimate of Dec 1, 2018 to Dec 10, 2018v4 Show 1 more changeShow less
    • Start date changed from estimate of Dec 1, 2018 to Dec 10, 2018
  39. Study sites: 1 to 2v3
  40. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  1. Study First Submitted
  • 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.
Exelixis
25 trials monitored
See 2 trials at risk
Liver Cancer
1,512 trials monitored
See 63 trials at risk
This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which participants receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab.
Trial Details
NCT Number NCT03755791
Lead Sponsor Exelixis
Conditions Hepatocellular Carcinoma
Enrollment 837 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov