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A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)

StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Trial completed · Study completion date changed from estimate of Oct 4, 2026 to Aug 25, 2026 · Eligibility criteria expanded, about 33 words · 3 more Show 6 more changesShow less
    • Trial completed
    • Study completion date changed from estimate of Oct 4, 2026 to Aug 25, 2026
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 5 of 8 entries
    • Site details revised at 3 of 48 sites
    • Publications: details revised at 1 of 1 entry
  2. Minor Completion date: Oct 4, 2025 to Oct 4, 2026v43
  3. Minor 2 versions Re-verified since Oct 29, 2024, no change to tracked fieldsv41-v42
  4. Minor Publications: details revised at 1 of 1 entryv40
  5. Notable Results first posted: Feb 28, 2024 Secondary endpoints revised (8)v39 Show 1 more changeShow less
    • Secondary endpoints revised (8)

    See this version in full on ClinicalTrials.gov ↗

Show 37 earlier versionsHide 37 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv38
  2. Minor Enrollment target: estimated 150 to confirmed 154 Primary completion date changed from estimate of Oct 4, 2025 to Feb 10, 2023v37 Show 1 more changeShow less
    • Primary completion date changed from estimate of Oct 4, 2025 to Feb 10, 2023
  3. Minor Re-verified, no change to tracked fieldsv36
  4. Minor Trial status: Recruiting to Active, Not Recruiting Site details revised at 48 of 48 sitesv35 Show 1 more changeShow less
    • Site details revised at 48 of 48 sites
  5. Minor Site details revised at 1 of 48 sitesv34
  6. Minor Site details revised at 3 of 48 sitesv33
  7. Minor Site details revised at 1 of 48 sitesv32
  8. Minor Site contacts updated at 1 of 48 sitesv31
  9. Minor Study sites: 47 to 48v30
  10. Minor Site details revised at 2 of 47 sitesv29
  11. Minor Study sites: 46 to 47v28
  12. Minor Study sites: 45 to 46v27
  13. Minor Re-verified, no change to tracked fieldsv26
  14. Minor Site contacts updated at 2 of 45 sitesv25
  15. Minor Study sites: 44 to 45v24
  16. Minor Study sites: 42 to 44v23
  17. Minor Study sites: 41 to 42v22
  18. Minor Study sites: 40 to 41v21
  19. Minor Study sites: 37 to 40v20
  20. Minor Study sites: 36 to 37v19
  21. Minor Study sites: 35 to 36v18
  22. Minor Site details revised at 1 of 35 sitesv17
  23. Minor Study sites: 34 to 35v16
  24. Minor Study sites: 32 to 34v15
  25. Minor Study sites: 31 to 32 Eligibility criteria expanded, about 50 wordsv14 Show 1 more changeShow less
    • Eligibility criteria expanded, about 50 words

    See this version in full on ClinicalTrials.gov ↗

  26. Minor Study sites: 29 to 31v13
  27. Minor Study sites: 27 to 29v12
  28. Minor Study sites: 25 to 27v11
  29. Minor Study sites: 24 to 25v10
  30. Minor Study sites: 22 to 24v9
  31. Minor Study sites: 21 to 22v8
  32. Minor Study sites: 18 to 21v7
  33. Minor Study sites: 17 to 18v6
  34. Minor Study sites: 15 to 17v5
  35. Minor Study sites: 13 to 15v4
  36. Minor Study sites: 5 to 13 Interventions: MK-6482 (Drug) to Belzutifan (Drug) · Eligibility criteria revised · Secondary endpoints revised (8) · 1 morev3 Show 4 more changesShow less
    • Interventions: MK-6482 (Drug) to Belzutifan (Drug)
    • Eligibility criteria revised
    • Secondary endpoints revised (8)
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  37. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 5 · Primary and study completion dates: Oct 3, 2025 to Oct 4, 2025 · Start date changed from estimate of Sep 10, 2020 to Sep 13, 2020v2 Show 3 more changesShow less
    • Study sites: 0 to 5
    • Primary and study completion dates: Oct 3, 2025 to Oct 4, 2025
    • Start date changed from estimate of Sep 10, 2020 to Sep 13, 2020
  1. Minor 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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This study will compare the efficacy and safety of two doses of belzutifan in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that the higher dose of belzutifan is superior to the standard dose in terms of objective response rate (ORR).
Trial Details
NCT Number NCT04489771
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Carcinoma, Renal Cell
Enrollment 154 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov