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S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Mar 15, 2026 to Dec 31, 2025 Site details revised at 1 of 174 sitesv23 Show 1 more changeShow less
    • Site details revised at 1 of 174 sites
  2. Primary completion date: Mar 15, 2025 to Mar 15, 2026 Completion date: Sep 15, 2025 to Jun 15, 2026v22 Show 1 more changeShow less
    • Completion date: Sep 15, 2025 to Jun 15, 2026
  3. Primary completion date: Dec 15, 2024 to Mar 15, 2025 Completion date: Feb 2025 to Sep 15, 2025v21 Show 1 more changeShow less
    • Completion date: Feb 2025 to Sep 15, 2025
  4. Re-verified, no change to tracked fieldsv20
  5. Start date: Feb 7, 2017 to Feb 24, 2017v19
Show 17 earlier versionsHide 17 earlier versions
  1. Primary completion date: Feb 15, 2023 to Dec 15, 2024v18
  2. Primary completion date: Feb 15, 2022 to Feb 15, 2023v17
  3. Re-verified, no change to tracked fieldsv16
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 969 to confirmed 1000 · Study sites revised (174)v15 Show 2 more changesShow less
    • Enrollment target: estimated 969 to confirmed 1000
    • Study sites revised (174)

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 171 to 174v14
  6. Study sites: 142 to 171v13
  7. Re-verified, no change to tracked fieldsv12
  8. Study sites: 137 to 142v11
  9. Study sites: 136 to 137v10
  10. Study sites: 93 to 136v9
  11. Re-verified, no change to tracked fieldsv8
  12. Primary completion date: Feb 2022 to Feb 15, 2022v7
  13. Study sites: 64 to 93v6
  14. Study sites: 40 to 64v5
  15. Study sites: 24 to 40v4
  16. Study sites: 5 to 24v3
  17. Study sites: 4 to 5 Study title expanded, about 1 wordv2 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating patients with bladder cancer that has not spread to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may stimulate the immune system to fight bladder cancer. Giving different versions of BCG with vaccine therapy may prevent bladder cancer from returning.
Trial Details
NCT Number NCT03091660
Lead Sponsor SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI)
Conditions Stage 0 Bladder Urothelial Carcinoma, Stage 0is Bladder Urothelial Carcinoma, Stage I Bladder Urothelial Carcinoma
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov