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

Eur Urol Focus. 2018 Jul;4(4):522-524. doi: 10.1016/j.euf.2018.08.015. Epub 2018 Sep 6.

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.

Trial registration: ClinicalTrials.gov NCT03091660.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adjuvants, Immunologic / administration & dosage
  • Adjuvants, Immunologic / adverse effects
  • Adjuvants, Immunologic / classification
  • Adjuvants, Immunologic / standards
  • BCG Vaccine* / administration & dosage
  • BCG Vaccine* / adverse effects
  • BCG Vaccine* / classification
  • BCG Vaccine* / standards
  • Female
  • Humans
  • Immunity, Cellular / drug effects
  • Immunotherapy / methods*
  • Injections, Intradermal / methods*
  • Male
  • Middle Aged
  • Neoplasm Invasiveness
  • Neoplasm Recurrence, Local / prevention & control
  • Neoplasm Staging
  • Progression-Free Survival
  • T-Lymphocytes / immunology*
  • Treatment Outcome
  • Urinary Bladder Neoplasms* / drug therapy
  • Urinary Bladder Neoplasms* / pathology

Substances

  • Adjuvants, Immunologic
  • BCG Vaccine

Associated data

  • ClinicalTrials.gov/NCT03091660