Therapeutic Plasma Exchange With Enfortumab Vedotin and Pembrolizumab for Treatment of Bladder Cancers

This phase II trial compares therapeutic plasma exchange followed by enfortumab vedotin and pembrolizumab to standard of care next-line therapy for the treatment of patients with bladder or upper urinary tract cancers that have spread from where they first started (primary site) to other places in the body (metastatic) and that have not responded to previous treatment (refractory). TPE is a process that slowly removes a patient's blood through an intravenous or central line. The blood is sent through a machine that separates the plasma (the liquid part of blood) from other blood components (re

Trial Details

NCT ID
NCT07087860
Phase
PHASE2
Sponsor
Mayo Clinic
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • Best Practice
  • Biospecimen Collection
  • Central Venous Cannula Insertion
  • Computed Tomography
  • Enfortumab Vedotin
  • Magnetic Resonance Imaging
Locations (sample)
  • Rochester, Minnesota, United States|44.02163,-92.4699

Key Eligibility Criteria

  • Age ≥ 18 years
  • GROPUS A and B (reCIPE-B1): Histologically proven urothelial carcinoma \[American Joint Committee on Cancer (AJCC) 2017\] of the bladder (BCa) or u…
  • NOTE: Primary or secondary progression are allowed, therapies are not required to be concurrent or immediately antecedent to enrollment)
  • COHORT C (CAKE ReCIPE): Histologically proven urothelial carcinoma (AJCC 2017) of the bladder (BCa) or upper urothelial tract (UTUC), that has prog…

For full eligibility, visit ClinicalTrials.gov.

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