Clinical Trial

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

Active, Not Recruiting Phase 3
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Summary
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.
Protocol Amendment History 22 amendments
This ClinicalTrials.gov record has been amended 22 times since 2017-03-21; most recent amendment 2026-03-20.
Status change: Recruiting → Active, Not Recruiting 2021-02-23
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 2017-02-24
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-06-15 (estimated)
Updated on ClinicalTrials.gov 2026-03-23