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

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

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

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. The S1602 Intergroup trial is a randomized phase III clinical trial that aims to evaluate the efficacy of priming with intradermal bacillus Calmette-Guérin (BCG) vaccine prior to standard intravesical BCG and to compare different BCG strains (TICE vs Tokyo-172). The study has enrolled over 100 of 969 planned patients.

Original languageEnglish (US)
JournalEuropean Urology Focus
DOIs
StateAccepted/In press - Jan 1 2018

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Urinary Bladder Neoplasms
Bacillus
T-Lymphocytes
BCG Vaccine
Phase III Clinical Trials
Tokyo
Therapeutics
Randomized Controlled Trials
Recurrence
National Cancer Institute (U.S.)
Program Evaluation
Clinical Trials
Survival
Neoplasms

ASJC Scopus subject areas

  • Urology

Cite this

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title = "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-na{\"i}ve High-grade Non-muscle-invasive Bladder Cancer",
abstract = "The S1602 Intergroup trial is a randomized phase III clinical trial that aims to test two important hypotheses: (1) priming with intradermal bacillus Calmette-Gu{\'e}rin (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. The S1602 Intergroup trial is a randomized phase III clinical trial that aims to evaluate the efficacy of priming with intradermal bacillus Calmette-Gu{\'e}rin (BCG) vaccine prior to standard intravesical BCG and to compare different BCG strains (TICE vs Tokyo-172). The study has enrolled over 100 of 969 planned patients.",
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AU - Delacroix, Scott

AU - Lowrance, William

AU - Lerner, Seth P.

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