Mayo Clinic Launches Phase 2 Clinical Trial for Bladder Cancer Treatment

Strategic Insights -

Mayo Clinic is leading an interventional clinical trial, Phase 2, to investigate the potential benefits of combining therapeutic plasma exchange (TPE) with existing treatments for bladder cancer. The trial aims to recruit 50 participants from the USA and is designed to compare the effectiveness of TPE, followed by enfortumab vedotin and pembrolizumab, to standard of care next-line therapy. The trial's principal investigator is Jacob J. Orme, MD, PhD.

Key Takeaways:

  • The trial, designated as ReCIPE-B1, is a Phase 2 clinical trial designed to investigate the efficacy of combining TPE with enfortumab vedotin and pembrolizumab in treating bladder cancer.
  • The trial aims to recruit 50 participants from the USA, with the study comparing the therapeutic outcomes of TPE followed by enfortumab vedotin and pembrolizumab to standard of care next-line therapy.
  • The study focuses on patients with bladder or upper urinary tract cancers that have spread from the primary site to other parts of the body and have not responded to previous treatment.
  • TPE is a process that slowly removes a patient's blood plasma, which is then replaced with replacement fluid, with the goal of enhancing the effectiveness of the existing treatments.
  • Enfortumab vedotin is a monoclonal antibody linked to an anticancer drug, and pembrolizumab is an immunotherapy that helps the immune system attack cancer cells.
  • The combination of TPE and enfortumab vedotin and pembrolizumab is being investigated as a potential treatment option for patients with metastatic and refractory bladder and urinary tract cancers.

Statistics:

  • The trial is seeking to recruit 50 participants from the USA.
  • The trial aims to compare the effectiveness of TPE, followed by enfortumab vedotin and pembrolizumab, to standard of care next-line therapy.
  • TPE is a process that separates the plasma from other blood components and replaces it with replacement fluid.
  • Enfortumab vedotin and pembrolizumab are being investigated as potential treatments for bladder cancer.
  • The trial is being conducted to determine the effectiveness of combining TPE with existing treatments for bladder cancer.

Sources:

  • ClinicalTrials.gov (# NCT07087860)
  • [URL: https://clinicaltrials.gov/study/NCT07087860](https://clinicaltrials.gov/study/NCT07087860)