A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer

Study acronym: ABLE-22
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Trial sites expanded: 76 → 80 locations
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 1 of 9 entries
  2. Re-verified, no change to tracked fieldsv40
  3. Study sites: 75 to 76v39
  4. Study sites: 74 to 75v38
  5. Study sites: 73 to 74v37
  6. Trial sites expanded: 66 → 73 locationsv36
  7. Study sites: 64 to 66
    • Eligibility criteria revised
    v35
  8. Study sites: 63 to 64v34
  9. Study sites revised (63)v33
  10. Study sites: 61 to 63v32
  11. Study sites: 60 to 61v31
  12. Study sites: 57 to 60v30
  13. Study sites: 55 to 57v29
  14. Study sites: 54 to 55v28
  15. Study sites: 44 to 54v27
  16. Study sites: 42 to 44v26
  17. Study sites: 40 to 42v25
  18. Study sites: 35 to 40v24
  19. Study sites: 21 to 35v23
  20. Study sites revised (21)v22
  21. Study sites: 18 to 21v21
  22. Study sites: 17 to 18v20
  23. Study sites: 15 to 17v19
  24. Study sites: 14 to 15v18
  25. Study sites: 12 to 14v17
  26. Primary completion date: Dec 31, 2030 to Jun 30, 2028
    • Secondary endpoints: details revised at 1 of 9 entries
    v16
  27. Study sites: 10 to 12v15
  28. Phase: Phase 2 to Phase 3
    • Enrollment target: 150 to 250
    • Eligibility criteria expanded, about 135 words
    • Secondary endpoints: 7 to 9
    v14
  29. 2 versions Re-verified since Apr 28, 2025, no change to tracked fieldsv12-v13
  30. Primary completion date: Jul 30, 2026 to Dec 31, 2030
    • Study sites: 9 to 10
    • Study completion date: Jul 30, 2028 to Dec 31, 2030
    v11
  31. Study sites: 8 to 9v10
  32. Study sites: 7 to 8v9
  33. Study sites: 5 to 7v8
  34. Study sites: 4 to 5v7
  35. Study sites: 3 to 4v6
  36. Study sites: 1 to 3
    • Eligibility criteria expanded, about 143 words
    • Secondary endpoints: 6 to 7
    v5
  37. Secondary endpoints: details revised at 1 of 6 entriesv4
  38. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 31, 2024 to Oct 1, 2024
    v3
  39. Study title shortened, about 4 wordsv2
  40. Study First Submitted
  • 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 pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a complete response (CR) at 3 months. In this trial, the safety and efficacy of intravesical instillation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy will be evaluated in participants with NMIBC CIS (± high-grade Ta/T1).
Trial Details
NCT Number NCT06545955
Lead Sponsor Ferring Pharmaceuticals
Conditions
(from sponsor)		 Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov