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Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Upper Tract Urothelial Cancer

Study acronym: NEPTUNE
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary endpoint(s) modified
    • Eligibility criteria shortened, about 33 words
    • Study description expanded, about 24 words
    • Study title shortened, about 1 word
    v9
  2. Study sites: 1 to 2v8
  3. Start date changed from estimate of Jun 2025 to Jul 22, 2025v7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v6
  5. Eligibility criteria shortened, about 68 wordsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Feb 2025 to Jun 2025
    • Primary and study completion dates: Nov 2027 to Mar 2028
    v4
  2. Start date: Oct 2024 to Feb 2025
    • Primary and study completion dates: Jul 2027 to Nov 2027
    v3
  3. Re-verified, no change to tracked fieldsv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in patients with high-grade localized/locally advanced cT1-4 N0-1 M0 upper tract urothelial cancer who are deemed eligible for curative-intent surgery (radical nephroureterectomy or distal ureterectomy) followed by adjuvant pembrolizumab.
Trial Details
NCT Number NCT06356155
Lead Sponsor University of Michigan Rogel Cancer Center
Conditions
(from sponsor)		 Urothelial Carcinoma
Related terms Carcinoma, Transitional Cell
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov