Enfortumab Vedotin and Pembrolizumab With Cystectomy and/or Ureterectomy for Locally Advanced or Metastatic Bladder and Upper Urothelial Tract Cancer, CAST-AI Trial

This phase IV trial tests the impact of standard of care enfortumab vedotin and pembrolizumab followed by removal of all or part of the bladder (cytoreductive cystectomy) and/or removal of all or part of the tube that carriers urine from the kidneys to the bladder (ureterectomy) on outcomes in patients with bladder and upper urothelial tract that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug

Trial Details

NCT ID
NCT06764095
Phase
PHASE4
Sponsor
Mayo Clinic
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • Biospecimen Collection
  • Computed Tomography
  • Cystectomy
  • Enfortumab Vedotin
  • Local Therapy
  • Magnetic Resonance Imaging
Locations (sample)
  • Rochester, Minnesota, United States|44.02163,-92.4699

Key Eligibility Criteria

  • 18 years of age or older at the time of informed consent
  • Histologically proven urothelial carcinoma \[American Joint Committee on Cancer (AJCC) 2017\] of the bladder (BCa) or upper urothelial tract (UTUC)…
  • The following variant histologic subtypes are permitted in any amount
  • Urothelial with squamous differentiation

For full eligibility, visit ClinicalTrials.gov.

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