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NCT03091660 · ClinicalTrials.gov registry record · Phase 3
S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer
A Phase 3 study of Stage 0 Bladder Urothelial Carcinoma and Stage 0is Bladder Urothelial Carcinoma, sponsored by SWOG Cancer Research Network.
- Active
- Registry status
- Phase 3
- Development phase
- 1,000
- Enrollment target
- 20
- Study locations
NCT03091660: Active Phase 3 study of Stage 0 Bladder Urothelial Carcinoma and Stage 0is Bladder Urothelial Carcinoma, sponsored by SWOG Cancer Research Network.
NCT03091660 is a Phase 3 study of Stage 0 Bladder Urothelial Carcinoma and Stage 0is Bladder Urothelial Carcinoma that is active but no longer recruiting, run by SWOG Cancer Research Network. The registered enrollment target is 1,000 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03091660, a Phase 3 study of Stage 0 Bladder Urothelial Carcinoma and Stage 0is Bladder Urothelial Carcinoma, is active but no longer recruiting, sponsored by SWOG Cancer Research Network.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,000 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Time to High Grade Recurrence
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL BCG Solution
- BIOLOGICAL BCG Tokyo-172 Strain Solution
- BIOLOGICAL BCG Tokyo-172 Strain Vaccine
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- Los Angeles County-USC Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Kaiser Permanente-Oakland - Oakland
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Stanford Cancer Institute Palo Alto - Palo Alto
- Kaiser Permanente-South Sacramento - Sacramento
- UCSF Medical Center-Mission Bay - San Francisco
- Kaiser Permanente-Vallejo - Vallejo
- Kaiser Permanente-Walnut Creek - Walnut Creek
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Connecticut
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven
- Yale University - New Haven
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
- George Washington University Medical Center - Washington D.C.
Alabama
- University of South Alabama Mitchell Cancer Institute - Mobile
Colorado
- University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2017-02-24 |
| Est. Completion | 2026-06-15 |
| Phase | Phase 3 |
What the registry record for NCT03091660 still lists
NCT03091660 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% higher).
The record links to 3 conditions, with Stage 0 Bladder Urothelial Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03091660 names 20 study sites across 6 states, led by California, Arizona, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03091660 about?
NCT03091660 is a clinical study titled "S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer". 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-infe...
What is the current status of trial NCT03091660?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2017-02-24. Estimated completion is 2026-06-15.
What conditions does trial NCT03091660 study?
This clinical trial studies the following conditions: Stage 0 Bladder Urothelial Carcinoma, Stage 0is Bladder Urothelial Carcinoma, Stage I Bladder Urothelial Carcinoma.
What interventions are being tested in trial NCT03091660?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), BCG Solution (BIOLOGICAL), BCG Tokyo-172 Strain Solution (BIOLOGICAL), BCG Tokyo-172 Strain Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03091660?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03091660 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03091660's enrollment target sits among peer trials
1,000 296th of 2000 higher than 1,690 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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