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-naïve High-grade Non-muscle-invasive Bladder Cancer.

The S1602 Intergroup trial is a randomized phase III clinical trial that aims to test two important hypotheses: (1) priming with intradermal bacillus Calmette-Guérin (BCG) vaccine prior to standard intravesical BCG improves response to BCG in terms of recurrence-free survival and (2) Tokyo-172 BCG strain is non-inferior to TICE BCG in terms of time to high-grade recurrence. The study was approved by the Cancer Therapy Evaluation Program of the National Cancer Institute and activated in spring 2017. Here, we provide a synopsis of the study background, design, and update of the clinical trial.

European urology focus. 2018 Sep 06 [Epub ahead of print]

Robert S Svatek, Cathy Tangen, Scott Delacroix, William Lowrance, Seth P Lerner

Department of Urology, University of Texas Health San Antonio, San Antonio, TX, USA. Electronic address: ., SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA., Louisiana State University, Department of Urology and Gulf South NCORP, New Orleans, LA, USA., Department of Urology, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA., Scott Department of Urology, Dan L. Duncan Cancer Center, Baylor College of Medicine, Houston, TX, USA.