A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder

People with a type of bladder cancer called muscle-invasive bladder cancer have cancer that has spread into the muscle wall of the bladder. The standard treatment is to have chemotherapy, followed by surgery to completely remove the bladder. This has a significant impact on people with long-term life-altering changes. There are also limited options for people who cannot have chemotherapy or who do not want their bladder removed. Studies show that enfortumab vedotin, when given with pembrolizumab, can help people with advanced bladder cancer. This treatment has also worked well for people with

Trial Details

NCT ID
NCT07475806
Phase
PHASE2
Sponsor
Astellas Pharma Global Development, Inc.
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Enfortumab Vedotin
  • Pembrolizumab
Locations (sample)
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Lisle, Illinois, United States|41.80114,-88.07479
  • New York, New York, United States|40.71427,-74.00597
  • Bala-Cynwyd, Pennsylvania, United States|40.00761,-75.23407

Key Eligibility Criteria

  • Participant has histologically-confirmed MIBC, stage cT2-T4aN0M0 or T1-T4aN1M0. NOTE: urothelial carcinomas (UCs) not originating from the bladder …
  • Participant has predominant UC histology (≥ 50%). NOTE: Participants with mixed histology are eligible provided the urothelial component is ≥ 50% (…
  • Participant is deemed eligible for radical cystectomy and pelvic lymph node dissection.
  • Participant has accessible archival tumor tissue from the primary tumor, for which source and availability have been confirmed prior to study inter…

For full eligibility, visit ClinicalTrials.gov.

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