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Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

Study acronym: CLEAR
StatusActive, Not Recruiting
PhasePhase 3
SponsorEisai Inc.
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion date: Mar 31, 2026 to Mar 31, 2027v34
  2. Secondary endpoints: details revised at 12 of 12 entriesv33
  3. Completion date: Jul 31, 2024 to Mar 31, 2026v32
  4. Secondary endpoints: details revised at 12 of 12 entries Study sites revised (183)v31 Show 1 more changeShow less
    • Study sites revised (183)

    See this version in full on ClinicalTrials.gov ↗

  5. Completion date: Oct 31, 2024 to Jul 31, 2024v30
Show 28 earlier versionsHide 28 earlier versions
  1. Re-verified, no change to tracked fieldsv29
  2. Study sites: 182 to 183 Completion date: Jul 31, 2022 to Oct 31, 2024 · Interventions: Sunitinib (Drug), everolimus (Drug), lenvatinib (Drug), pembrolizumab (Drug) to Everolimus (Drug), Lenvatinib (Drug), Pembrolizumab (Drug), Sunitinib (Drug) · Eligibility criteria expanded, about 717 wordsv28 Show 3 more changesShow less
    • Completion date: Jul 31, 2022 to Oct 31, 2024
    • Interventions: Sunitinib (Drug), everolimus (Drug), lenvatinib (Drug), pembrolizumab (Drug) to Everolimus (Drug), Lenvatinib (Drug), Pembrolizumab (Drug), Sunitinib (Drug)
    • Eligibility criteria expanded, about 717 words

    See this version in full on ClinicalTrials.gov ↗

  3. Results first posted: Sep 24, 2021 Primary endpoint revised · Study sites: 225 to 182 · Secondary endpoints: 10 to 12v27 Show 3 more changesShow less
    • Primary endpoint revised
    • Study sites: 225 to 182
    • Secondary endpoints: 10 to 12

    See this version in full on ClinicalTrials.gov ↗

  4. Completion date: Apr 30, 2021 to Jul 31, 2022 Collaborators expanded, about 5 wordsv26 Show 1 more changeShow less
    • Collaborators expanded, about 5 words

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  5. Enrollment target: 959 to 1069v25
  6. Primary completion date changed from estimate of Aug 14, 2020 to Aug 28, 2020 Completion date: Apr 30, 2022 to Apr 30, 2021 · Start date: Oct 27, 2016 to Oct 13, 2016v24 Show 2 more changesShow less
    • Completion date: Apr 30, 2022 to Apr 30, 2021
    • Start date: Oct 27, 2016 to Oct 13, 2016
  7. Enrollment target: 1069 to 959v23
  8. Primary completion date: Apr 24, 2020 to Aug 14, 2020 Completion date: Feb 26, 2021 to Apr 30, 2022 · Start date: Oct 13, 2016 to Oct 27, 2016 · Secondary endpoints: details revised at 10 of 10 entriesv22 Show 3 more changesShow less
    • Completion date: Feb 26, 2021 to Apr 30, 2022
    • Start date: Oct 13, 2016 to Oct 27, 2016
    • Secondary endpoints: details revised at 10 of 10 entries
  9. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 1050 to confirmed 1069 · Study sites revised (225)v21 Show 2 more changesShow less
    • Enrollment target: estimated 1050 to confirmed 1069
    • Study sites revised (225)

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites: 217 to 225v20
  11. Study sites: 194 to 217v19
  12. Re-verified, no change to tracked fieldsv18
  13. Study sites: 304 to 194v17
  14. Completion date: Apr 24, 2020 to Feb 26, 2021v16
  15. Primary completion date: Apr 2020 to Apr 24, 2020 Completion date: Feb 2021 to Apr 24, 2020 · Site details revised at 13 of 304 sitesv15 Show 2 more changesShow less
    • Completion date: Feb 2021 to Apr 24, 2020
    • Site details revised at 13 of 304 sites
  16. Enrollment target: 707 to 1050v14
  17. Re-verified, no change to tracked fieldsv13
  18. Enrollment target: 735 to 707 Primary completion date: Oct 15, 2019 to Apr 2020 · Completion date: Jan 15, 2020 to Feb 2021 · Eligibility criteria expanded, about 8 words · 1 morev12 Show 4 more changesShow less
    • Primary completion date: Oct 15, 2019 to Apr 2020
    • Completion date: Jan 15, 2020 to Feb 2021
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 8 of 10 entries

    See this version in full on ClinicalTrials.gov ↗

  19. Study sites: 149 to 304v11
  20. Study sites: 119 to 149 Secondary endpoints revised (10) · Eligibility criteria expanded, about 2 wordsv10 Show 2 more changesShow less
    • Secondary endpoints revised (10)
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  21. Enrollment target: 9 to 735 Study sites: 117 to 119v9 Show 1 more changeShow less
    • Study sites: 117 to 119
  22. Enrollment target: 735 to 9 Study sites: 19 to 117v8 Show 1 more changeShow less
    • Study sites: 19 to 117
  23. Re-verified, no change to tracked fieldsv7
  24. Primary endpoint revised Study sites: 14 to 19 · Eligibility criteria expanded, about 15 words · Secondary endpoints: 7 to 10v6 Show 3 more changesShow less
    • Study sites: 14 to 19
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: 7 to 10

    See this version in full on ClinicalTrials.gov ↗

  25. Study sites: 2 to 14 Primary completion date: Oct 2019 to Oct 15, 2019 · Completion date: Jan 2020 to Jan 15, 2020 · Start date: Sep 2016 to Oct 13, 2016 · 2 morev5 Show 5 more changesShow less
    • Primary completion date: Oct 2019 to Oct 15, 2019
    • Completion date: Jan 2020 to Jan 15, 2020
    • Start date: Sep 2016 to Oct 13, 2016
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 3 to 7

    See this version in full on ClinicalTrials.gov ↗

  26. Study sites: 1 to 2 Eligibility criteria revisedv4 Show 1 more changeShow less
    • Eligibility criteria revised

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  27. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Eligibility criteria revisedv3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  28. Primary completion date: Nov 2020 to Oct 2019 Completion date: Nov 2022 to Jan 2020v2 Show 1 more changeShow less
    • Completion date: Nov 2022 to Jan 2020
  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.
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The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review \[IIR\] using Response Evaluation Criteria in Solid Tumors \[RECIST 1.1\]) as first-line treatment in participants with advanced renal cell carcinoma (RCC).
Trial Details
NCT Number NCT02811861
Lead Sponsor Eisai Inc.
Collaborators: Merck Sharp & Dohme LLC
Conditions Renal Cell Carcinoma
Enrollment 1,069 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov