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ACTIVE NOT RECRUITING Phase 3

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

NCT03091660 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 1,000 participants
Start Date 2017-02-24
Est. Completion 2026-06-15
Phase Phase 3

Sponsor

SWOG Cancer Research Network

212 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03091660

The ClinicalTrials.gov registry entry for NCT03091660 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 212 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03091660 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Arizona, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03091660?

This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial