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

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.

Timeline

Start

2017-02-24

Primary completion

2025-12-31

Completion

2026-06-15

Publications

• Svatek RS, Tangen C, Delacroix S, Lowrance W, Lerner SP. Background and Update for S1602 "A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-naive High-grade Non-muscle-invasive Bladder Cancer. Eur Urol Focus. 2018 Jul;4(4):522-524. doi: 10.1016/j.euf.2018.08.015. Epub 2018 Sep 6.

Drugs

Indications