A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

Study acronym: MoonRISe-1
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC
    • Secondary endpoints: details revised at 6 of 10 entries
    • Study sites revised (193)
    • Eligibility criteria expanded, about 4 words
  2. Study sites revised (193)v38
  3. Site details revised at 1 of 193 sitesv37
  4. Site details revised at 1 of 193 sitesv36
  5. Re-verified, no change to tracked fieldsv35
Show 33 earlier versionsHide 33 earlier versions
  1. Study sites revised (193)v34
  2. Study sites revised (193)v33
  3. Enrollment target: 561 to 641
    • Study completion date: Jun 28, 2028 to Dec 31, 2032
    • Site details revised at 22 of 193 sites
    v32
  4. Enrollment target: 641 to 561v31 Show 4 more changesShow less
    • Eligibility criteria expanded, about 84 words
    • Secondary endpoints revised (10)
    • Site details revised at 80 of 193 sites
    • Study arms: 2 to 4
  5. Site details revised at 2 of 193 sitesv30
  6. Enrollment target: 560 to 641
    • Site details revised at 10 of 193 sites
    v29
  7. Site details revised at 3 of 193 sitesv28
  8. Site details revised at 2 of 193 sitesv27
  9. Enrollment target: 540 to 560
    • Site details revised at 10 of 193 sites
    v26
  10. Re-verified, no change to tracked fieldsv25
  11. Study sites: 192 to 193v24
  12. Re-verified, no change to tracked fieldsv23
  13. Study sites: 191 to 192v22
  14. Study sites: 190 to 191
    • Start date: Apr 1, 2024 to Apr 18, 2024
    v21
  15. Study sites: 189 to 190v20
  16. Start date: Apr 18, 2024 to Apr 1, 2024v19
  17. Site details revised at 1 of 189 sitesv18
  18. Start date: Jan 15, 2024 to Apr 18, 2024v17
  19. Study sites: 188 to 189v16
  20. Study sites: 184 to 188
    • Start date: Apr 18, 2024 to Jan 15, 2024
    • Eligibility criteria expanded, about 76 words
    v15
  21. Study sites: 175 to 184v14
  22. Re-verified, no change to tracked fieldsv13
  23. Study sites: 159 to 175v12
  24. Re-verified, no change to tracked fieldsv11
  25. Study sites: 148 to 159v10
  26. Study sites: 125 to 148v9
  27. Study sites: 88 to 125v8
  28. Study sites: 46 to 88v7
  29. Study sites: 27 to 46v6
  30. Study sites: 10 to 27v5
  31. Study sites: 7 to 10v4
  32. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 7
    • Start date changed from estimate of Apr 30, 2024 to Apr 18, 2024
    v3
  33. Study sites: 1 to 0v2
  1. 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.
Johnson & Johnson
290 trials monitored
See 16 trials at risk
Bladder Cancer
1,060 trials monitored
See 79 trials at risk
The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.
Trial Details
NCT Number NCT06319820
Lead Sponsor Janssen Research & Development, LLC
Conditions
(from sponsor)		 Non-Muscle Invasive Bladder Neoplasms
Related terms Non-Muscle Invasive Bladder Neoplasms
Enrollment 641 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov