Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer

This phase Ib/II trial studies the side effects, best dose, and effectiveness of enfortumab vedotin (EV) in combination with pembrolizumab and radiation therapy for treating patients with muscle invasive bladder cancer. Standard of care treatment for muscle invasive bladder cancer is chemotherapy, to shrink the tumor before the main treatment is given (neoadjuvant), followed by surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). In cases where patients are not candidates for the standard of care approach or prefer a bladder sparing option, tri-modali

Trial Details

NCT ID
NCT06470282
Phase
PHASE1 / PHASE2
Sponsor
University of California, San Francisco
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Enfortumab Vedotin
  • Pembrolizumab
  • Intensity Modulated Radiation Therapy (IMRT)
  • Transurethral Resection of Bladder Tumor
  • Cystoscopy (CS)
  • Computed Tomography (CT)
Locations (sample)
  • San Francisco, California, United States|37.77493,-122.41942

Key Eligibility Criteria

  • Biopsy-confirmed muscle-invasive bladder cancer (cT2,T3,T4a). (Note: Tissue samples are required.) (Participants with cT3/T4a staged disease will b…
  • Urothelial histology present. Mixed histologies other than small cell/neuroendocrine are allowed as long as some urothelial histology is present. N…
  • Must be judged by the investigator to be ineligible for radical cystectomy or electing not to undergo radical cystectomy.
  • Must be eligible for and agree to receive bladder irradiation as determined by the treating investigator.

For full eligibility, visit ClinicalTrials.gov.

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