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A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

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

Record History

The 50 most recent of 103 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Completion pushed from Dec 31, 2026 to Dec 31, 2027 · Secondary endpoints revised (20) · Site details revised at 23 of 345 sites Show 3 more changesShow less
    • Completion pushed from Dec 31, 2026 to Dec 31, 2027
    • Secondary endpoints revised (20)
    • Site details revised at 23 of 345 sites
  3. 2 versions Re-verified since Jun 4, 2026, no change to tracked fieldsv100-v101
  4. Study sites revised (345)v99 See this version in full on ClinicalTrials.gov ↗
  5. Re-verified, no change to tracked fieldsv98
Show 44 earlier versionsHide 44 earlier versions
  1. Study sites revised (345)v97 See this version in full on ClinicalTrials.gov ↗
  2. Site details revised at 1 of 345 sitesv96
  3. 2 versions Re-verified since Nov 6, 2025, no change to tracked fieldsv94-v95
  4. Completion date: Nov 1, 2026 to Dec 31, 2026v93
  5. 5 versions Re-verified since Jun 20, 2025, no change to tracked fieldsv88-v92
  6. Results first posted: May 14, 2025 Primary completion date: Jan 15, 2023 to Apr 15, 2024 · Study sites revised (345)v87 Show 2 more changesShow less
    • Primary completion date: Jan 15, 2023 to Apr 15, 2024
    • Study sites revised (345)

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites revised (345)v86 See this version in full on ClinicalTrials.gov ↗
  8. Re-verified, no change to tracked fieldsv85
  9. Study sites revised (345)v84 See this version in full on ClinicalTrials.gov ↗
  10. Re-verified, no change to tracked fieldsv83
  11. Study sites revised (345)v82 See this version in full on ClinicalTrials.gov ↗
  12. Primary completion date changed from estimate of Sep 11, 2024 to Jan 15, 2023 Study sites revised (345)v81 Show 1 more changeShow less
    • Study sites revised (345)

    See this version in full on ClinicalTrials.gov ↗

  13. Site details revised at 1 of 345 sitesv80
  14. Study sites revised (345)v79 See this version in full on ClinicalTrials.gov ↗
  15. Study sites revised (345)v78 See this version in full on ClinicalTrials.gov ↗
  16. Study sites revised (345)v77 See this version in full on ClinicalTrials.gov ↗
  17. Study sites revised (345)v76 See this version in full on ClinicalTrials.gov ↗
  18. Completion date: Sep 11, 2024 to Nov 1, 2026 Study sites revised (345)v75 Show 1 more changeShow less
    • Study sites revised (345)

    See this version in full on ClinicalTrials.gov ↗

  19. Primary completion date: Feb 29, 2024 to Sep 11, 2024 Study sites revised (345)v74 Show 1 more changeShow less
    • Study sites revised (345)

    See this version in full on ClinicalTrials.gov ↗

  20. Completion date: Aug 7, 2024 to Sep 11, 2024 Study sites revised (345)v73 Show 1 more changeShow less
    • Study sites revised (345)

    See this version in full on ClinicalTrials.gov ↗

  21. Study sites revised (345)v72 See this version in full on ClinicalTrials.gov ↗
  22. Study sites revised (345)v71 See this version in full on ClinicalTrials.gov ↗
  23. Primary completion date: Oct 31, 2023 to Feb 29, 2024 Completion date: Apr 26, 2024 to Aug 7, 2024 · Study sites revised (345)v70 Show 2 more changesShow less
    • Completion date: Apr 26, 2024 to Aug 7, 2024
    • Study sites revised (345)

    See this version in full on ClinicalTrials.gov ↗

  24. Study sites: 346 to 345v69
  25. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 631 to confirmed 629 · Study sites: 345 to 346 · Completion date: Oct 31, 2033 to Apr 26, 2024v68 Show 3 more changesShow less
    • Enrollment target: estimated 631 to confirmed 629
    • Study sites: 345 to 346
    • Completion date: Oct 31, 2033 to Apr 26, 2024
  26. Site details revised at 18 of 345 sitesv67
  27. Study sites revised (345)v66 See this version in full on ClinicalTrials.gov ↗
  28. Completion date: Apr 26, 2024 to Oct 31, 2033 Site details revised at 20 of 345 sitesv65 Show 1 more changeShow less
    • Site details revised at 20 of 345 sites
  29. Study sites revised (345)v64 See this version in full on ClinicalTrials.gov ↗
  30. Primary completion date: Mar 31, 2023 to Oct 31, 2023 Study sites: 415 to 345v63 Show 1 more changeShow less
    • Study sites: 415 to 345
  31. Study sites revised (415)v62 See this version in full on ClinicalTrials.gov ↗
  32. Study sites revised (415)v61 See this version in full on ClinicalTrials.gov ↗
  33. Site details revised at 2 of 415 sitesv60
  34. Primary completion date: Oct 30, 2022 to Mar 31, 2023 Completion date: Apr 26, 2026 to Apr 26, 2024 · Study sites revised (415)v59 Show 2 more changesShow less
    • Completion date: Apr 26, 2026 to Apr 26, 2024
    • Study sites revised (415)

    See this version in full on ClinicalTrials.gov ↗

  35. Completion date: Oct 30, 2023 to Apr 26, 2026 Study sites revised (415)v58 Show 1 more changeShow less
    • Study sites revised (415)

    See this version in full on ClinicalTrials.gov ↗

  36. Study sites revised (415)v57 See this version in full on ClinicalTrials.gov ↗
  37. Study sites revised (415)v56 See this version in full on ClinicalTrials.gov ↗
  38. Site details revised at 4 of 415 sitesv55
  39. Site details revised at 4 of 415 sitesv54
  • 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.
Johnson & Johnson
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The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-\[L\]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).
Trial Details
NCT Number NCT03390504
Lead Sponsor Janssen Research & Development, LLC
Conditions Urothelial Cancer
Enrollment 629 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov