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Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

Study acronym: EV-302
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 89 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv89
  2. Completion date: Nov 30, 2027 to Mar 1, 2028v88
  3. Results first posted: Sep 27, 2024v87
  4. Enrollment target: 1030 to 886 Study arms: 3 to 2v86 Show 1 more changeShow less
    • Study arms: 3 to 2
  5. Primary endpoints revised (2) Secondary endpoints: 16 to 19v85 Show 1 more changeShow less
    • Secondary endpoints: 16 to 19

    See this version in full on ClinicalTrials.gov ↗

Show 45 earlier versionsHide 45 earlier versions
  1. Completion date: Sep 30, 2027 to Nov 30, 2027v84
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 990 to confirmed 1030 · Site details revised at 260 of 260 sitesv83 Show 2 more changesShow less
    • Enrollment target: estimated 990 to confirmed 1030
    • Site details revised at 260 of 260 sites
  3. Site details revised at 8 of 260 sitesv82
  4. Site details revised at 1 of 260 sitesv81
  5. Site details revised at 6 of 260 sitesv80
  6. Site details revised at 1 of 260 sitesv79
  7. Site details revised at 14 of 260 sitesv78
  8. Primary endpoints revised (2) Primary completion date changed from estimate of Nov 30, 2023 to Aug 8, 2023v77 Show 1 more changeShow less
    • Primary completion date changed from estimate of Nov 30, 2023 to Aug 8, 2023

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 259 to 260v76
  10. Study sites: 258 to 259v75
  11. Study sites: 257 to 258 Eligibility criteria revisedv74 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 254 to 257v73
  13. Study sites: 253 to 254v72
  14. Study sites: 251 to 253v71
  15. Re-verified, no change to tracked fieldsv70
  16. Study sites: 247 to 251v69
  17. Study sites: 246 to 247v68
  18. Secondary endpoints revised (16)v67 See this version in full on ClinicalTrials.gov ↗
  19. Study sites: 239 to 246v66
  20. Site details revised at 3 of 239 sitesv65
  21. Secondary endpoints: 13 to 16v64 See this version in full on ClinicalTrials.gov ↗
  22. Study sites: 234 to 239v63
  23. Site details revised at 181 of 234 sitesv62
  24. Study sites: 233 to 234v61
  25. Study sites: 229 to 233v60
  26. Study sites: 223 to 229v59
  27. Study sites: 222 to 223v58
  28. Study sites: 221 to 222v57
  29. Study sites: 220 to 221v56
  30. Study sites: 217 to 220v55
  31. Enrollment target: 860 to 990 Completion date: Nov 30, 2023 to Sep 30, 2027v54 Show 1 more changeShow less
    • Completion date: Nov 30, 2023 to Sep 30, 2027
  32. Study sites: 211 to 217v53
  33. Study sites: 203 to 211v52
  34. Site details revised at 4 of 203 sitesv51
  35. Study sites: 190 to 203v50
  36. Site details revised at 10 of 190 sitesv49
  37. Site details revised at 5 of 190 sitesv48
  38. Study sites: 184 to 190v47
  39. Site details revised at 18 of 184 sitesv46
  40. Study sites: 182 to 184v45
  41. Primary endpoints revised (2)v44 See this version in full on ClinicalTrials.gov ↗
  42. Study sites: 170 to 182v43
  43. Study sites: 169 to 170v42
  44. Study sites: 156 to 169v41
  45. Enrollment target: 760 to 860 Secondary endpoints revised (13)v40 Show 1 more changeShow less
    • Secondary endpoints revised (13)

    See this version in full on ClinicalTrials.gov ↗

  • 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.
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.
Trial Details
NCT Number NCT04223856
Lead Sponsor Astellas Pharma Global Development, Inc.
Collaborators: Merck Sharp & Dohme LLC, Seagen Inc.
Conditions Urothelial Cancer
Enrollment 886 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov