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Pembrolizumab and Enfortumab Vedotin With Pembrolizumab Prior to and After Radical Nephroureterectomy for High-Risk Upper Tract Urothelial Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion moved earlier from Dec 1, 2027 to Jan 1, 2027
    • Study completion moved earlier from Dec 1, 2028 to Jan 1, 2028
    • Start date: Jun 26, 2024 to Jun 24, 2024
    v9
  2. Re-verified, no change to tracked fieldsv8
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2024 to Jun 26, 2024
    • Site details revised
    v7
  4. Primary completion date: Jan 1, 2027 to Dec 1, 2027
    • Start date: Jun 1, 2024 to Dec 1, 2024
    • Study completion date: Jan 1, 2028 to Dec 1, 2028
    v6
  5. Start date: Jan 1, 2024 to Jun 1, 2024v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Oct 1, 2023 to Jan 1, 2024
    • Primary completion date: Oct 1, 2026 to Jan 1, 2027
    • Study completion date: Oct 1, 2027 to Jan 1, 2028
    v4
  2. Start date: Aug 1, 2023 to Oct 1, 2023
    • Primary completion date: Aug 1, 2026 to Oct 1, 2026
    • Study completion date: Aug 1, 2027 to Oct 1, 2027
    v3
  3. Primary completion date: Jan 1, 2026 to Aug 1, 2026
    • Start date: May 1, 2023 to Aug 1, 2023
    • Study completion date: Jan 1, 2027 to Aug 1, 2027
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase II clinical trial tests how well pembrolizumab plus enfortumab vedotin prior to and after radical nephroureterectomy works in treating patients with high-risk upper tract urothelial cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Enfortumab vedotin (EV) is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of cancer cells. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Radical nephroureterectomy (RNU) is the surgical removal of a kidney and its ureter. Giving pembrolizumab plus enfortumab vedotin before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed and giving pembrolizumab after surgery may kill any remaining cancer cells.
Trial Details
NCT Number NCT05775471
Lead Sponsor Jonsson Comprehensive Cancer Center
Collaborators: Merck Sharp & Dohme LLC, Seagen Inc.
Conditions
(from sponsor)		 Renal Pelvis and Ureter Urothelial Carcinoma
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov