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A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 70 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Completion pushed from Sep 30, 2026 to Mar 31, 2027 Eligibility criteria expanded, about 106 words · Secondary endpoints: details revised at 6 of 10 entries · Study description revised · 3 more Show 6 more changesShow less
    • Eligibility criteria expanded, about 106 words
    • Secondary endpoints: details revised at 6 of 10 entries
    • Study description revised
    • Site details revised at 1 of 39 sites
    • Collaborators: details revised at 1 of 2 entries
    • Publications: details revised at 3 of 3 entries
  2. Re-verified, no change to tracked fieldsv69
  3. Results first posted: Apr 13, 2026v68
  4. Primary endpoints revised (2) Start date: Mar 9, 2020 to Mar 10, 2020 · Secondary endpoints: 18 to 10v67 Show 2 more changesShow less
    • Start date: Mar 9, 2020 to Mar 10, 2020
    • Secondary endpoints: 18 to 10

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv66
Show 45 earlier versionsHide 45 earlier versions
  1. Primary completion date changed from estimate of Sep 30, 2026 to Feb 25, 2025v65
  2. 7 versions Re-verified since Oct 14, 2024, no change to tracked fieldsv58-v64
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 320 to confirmed 329 · Study sites: 51 to 39v57 Show 2 more changesShow less
    • Enrollment target: estimated 320 to confirmed 329
    • Study sites: 51 to 39
  4. Site details revised at 1 of 51 sitesv56
  5. Site details revised at 1 of 51 sitesv55
  6. Re-verified, no change to tracked fieldsv54
  7. Eligibility criteria shortened, about 6 words Site details revised at 1 of 51 sitesv53 Show 1 more changeShow less
    • Site details revised at 1 of 51 sites

    See this version in full on ClinicalTrials.gov ↗

  8. Site details revised at 2 of 51 sitesv52
  9. Site details revised at 5 of 51 sitesv51
  10. Site details revised at 4 of 51 sitesv50
  11. Site details revised at 3 of 51 sitesv49
  12. Site details revised at 4 of 51 sitesv48
  13. Trial status: Active, Not Recruiting to Recruiting Study sites: 41 to 51v47 Show 1 more changeShow less
    • Study sites: 41 to 51
  14. Re-verified, no change to tracked fieldsv46
  15. Eligibility criteria revisedv45 See this version in full on ClinicalTrials.gov ↗
  16. Primary and study completion dates: Jul 31, 2024 to Sep 30, 2026 Enrollment target: 288 to 320 · Interventions: enfortumab vedotin (Drug) to enfortumab vedotin (Drug), pembrolizumab (Drug) · Eligibility criteria expanded, about 632 words · 1 morev44 Show 4 more changesShow less
    • Enrollment target: 288 to 320
    • Interventions: enfortumab vedotin (Drug) to enfortumab vedotin (Drug), pembrolizumab (Drug)
    • Eligibility criteria expanded, about 632 words
    • Study arms: 8 to 9

    See this version in full on ClinicalTrials.gov ↗

  17. 2 versions Re-verified since Mar 23, 2023, no change to tracked fieldsv42-v43
  18. Study sites: 42 to 41v41
  19. Re-verified, no change to tracked fieldsv40
  20. Primary and study completion dates: Apr 30, 2024 to Jul 31, 2024v39
  21. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 280 to confirmed 288 · Study sites: 51 to 42v38 Show 2 more changesShow less
    • Enrollment target: estimated 280 to confirmed 288
    • Study sites: 51 to 42
  22. Site details revised at 5 of 51 sitesv37
  23. Re-verified, no change to tracked fieldsv36
  24. Site details revised at 2 of 51 sitesv35
  25. 5 versions Re-verified since Apr 6, 2022, no change to tracked fieldsv30-v34
  26. Site details revised at 2 of 51 sitesv29
  27. Primary and study completion dates: Jul 31, 2023 to Apr 30, 2024v28
  28. Study sites: 48 to 51v27
  29. Enrollment target: 240 to 280 Study sites: 45 to 48 · Study arms: 6 to 8v26 Show 2 more changesShow less
    • Study sites: 45 to 48
    • Study arms: 6 to 8
  30. Study sites: 44 to 45v25
  31. Study sites: 42 to 44v24
  32. Study sites: 40 to 42v23
  33. Study sites: 38 to 40v22
  34. Study sites: 37 to 38v21
  • 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.
The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1. This study will also assess other measures of antitumor activity; overall survival (OS); as well as the safety and tolerability of enfortumab vedotin for cohorts 1 to 8 and enfortumab vedotin + pembrolizumab in cohort 9.
Trial Details
NCT Number NCT04225117
Lead Sponsor Astellas Pharma Global Development, Inc.
Collaborators: Seagen Inc., Merck Sharp & Dohme LLC
Conditions Locally Advanced or Metastatic Malignant Solid Tumors
Enrollment 329 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov