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Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 70 to confirmed 60
    • Site details revised
    v6
  2. 2 versions Re-verified since Jul 10, 2024, no change to tracked fieldsv4-v5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 25, 2023 to Jun 14, 2023
    • Site details revised
    v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a non-randomized two arm open-label phase 2 pilot study in adult subjects with locally advanced or metastatic urothelial cancer. The study will investigate an alternative administration schedule of EV given as monotherapy and in combination with pembrolizumab.
Trial Details
NCT Number NCT05923190
Lead Sponsor Fox Chase Cancer Center
Conditions
(from sponsor)		 Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma
Related terms Carcinoma, Transitional Cell
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov