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Completed PHASE3 INTERVENTIONAL 2-arm NCT03713593

Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)

A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma (LEAP-002)

Sponsor: Eisai Inc.

Updated 35 times since 2018 Last updated: Jan 15, 2026 Started: Dec 31, 2018 Primary completion: Jun 21, 2022 Completion: Sep 24, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Carcinoma, Hepatocellular, this trial is completed. The trial is conducted by Eisai Inc. and has accumulated 35 data snapshots since 2018. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Nov 2018 – ~Jan 2019 · 2 months · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jan 2021 · 8 months · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Jan 2022 · 8 months · monthly snapshot~Jan 2022 – ~Jun 2022 · 5 months · monthly snapshot~Jun 2022 – ~Sep 2022 · 3 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Mar 2023 · 4 months · monthly snapshot~Mar 2023 – ~Aug 2023 · 5 months · monthly snapshot~Aug 2023 – ~Feb 2024 · 6 months · monthly snapshot~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Sep 2025 · 10 months · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – ~Nov 2025 · 31 days · monthly snapshot~Nov 2025 – ~Dec 2025 · 30 days · monthly snapshot~Dec 2025 – ~Feb 2026 · 2 months · monthly snapshot~Feb 2026 – present · 7 months · monthly snapshot

Change History

35 versions recorded
  1. Feb 2026 — Present [monthly]

    Completed PHASE3

  2. Dec 2025 — Feb 2026 [monthly]

    Completed PHASE3

  3. Nov 2025 — Dec 2025 [monthly]

    Completed PHASE3

  4. Oct 2025 — Nov 2025 [monthly]

    Completed PHASE3

  5. Sep 2025 — Oct 2025 [monthly]

    Completed PHASE3

Show 30 earlier versions
  1. Nov 2024 — Sep 2025 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  2. Sep 2024 — Nov 2024 [monthly]

    Active Not Recruiting PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  4. Feb 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

  5. Aug 2023 — Feb 2024 [monthly]

    Active Not Recruiting PHASE3

  6. Mar 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE3

  7. Nov 2022 — Mar 2023 [monthly]

    Active Not Recruiting PHASE3

  8. Sep 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE3

  9. Jun 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

  10. Jan 2022 — Jun 2022 [monthly]

    Active Not Recruiting PHASE3

  11. May 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE3

  12. Jan 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE3

  13. May 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  14. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE3

  15. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE3

  16. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE3

  17. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE3

  18. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE3

  19. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE3

  20. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

  21. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE3

  22. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE3

  23. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE3

  24. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE3

  25. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE3

  26. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE3

  27. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

  28. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  29. Jan 2019 — Feb 2019 [monthly]

    Not Yet Recruiting PHASE3

  30. Nov 2018 — Jan 2019 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Eisai Inc.
  • Merck Sharp & Dohme LLC
Data source: Merck Sharp & Dohme LLC

For direct contact, visit the study record on ClinicalTrials.gov .