Phase I Trial of Intravesical Bacillus Calmette-Guérin Combined with Intravenous Pembrolizumab in Recurrent or Persistent High-Grade Non-Muscle-Invasive Bladder Cancer After Previous Bacillus Calmette-Guérin Treatment - Beyond the Abstract

The presented abstract outlines the results of a phase I dose-escalation trial (NCT02324582) that investigated the use of intravesical Bacillus Calmette-Guérin (BCG) in combination with systemic pembrolizumab as a potential treatment for high-grade non-muscle-invasive bladder cancer (HGNMIBC) in patients who had persistent or recurrent disease following prior intravesical BCG therapy. The study aimed to assess the safety of this combination therapy as its primary endpoint and evaluate clinical activity at three months post-BCG treatment as the secondary endpoint.

Since the initial publication of this abstract, the research team has continued to investigate the outcomes and impacts of their intervention. One notable aspect explored is the evaluation of urinary bother in patients post-treatment. This is a critical aspect of any medical study involving urological conditions, as it directly affects patients' quality of life. The team employed the American Urological Association symptom index to gauge the extent of urinary bother experienced by the treated individuals. This analysis is crucial in assessing the holistic effectiveness of the intervention and its real-world applicability. In addition, the research team has embarked on an intriguing avenue of investigation by analyzing urine samples from patients who participated in the trial. This analysis could yield valuable insights into the physiological changes and potential biomarkers associated with the treatment. Understanding the biological mechanisms behind treatment response is fundamental for advancing medical knowledge and refining therapeutic approaches.

Evidently, the research team has been proactive in pursuing these additional analyses and has made substantial progress. The upcoming manuscripts will likely provide a more comprehensive and nuanced understanding of the research outcomes. The promise of these findings is undoubtedly exciting, as they can advance medical understanding, improve patient care, and shape future research directions in the field of urology.

Written by:

  • Shaheen Alanee, MD, Detroit Medical Center, Detroit, MI
  • Kathy Robinson, PhD, Simmons Cancer Institute At Southern Illinois University School of Medicine, Springfield, IL
  • Krishna Rao, MD, Department of Urology, Loyola University Medical Center, Maywood, IL
Read the Abstract