Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Enrollment closed, study ongoing
    • Final enrollment: 27 participants (planned 23)
    • Site details revised at 10 of 10 sites
  2. Eligibility criteria expanded, about 69 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Collaborators: details revised at 1 of 3 entries
  3. Re-verified, no change to tracked fieldsv24
  4. Site details revised at 1 of 10 sitesv23
  5. Re-verified, no change to tracked fieldsv22
Show 20 earlier versionsHide 20 earlier versions
  1. Primary and study completion dates: Jun 2026 to Jun 2027
    • Site details revised at 1 of 10 sites
    v21
  2. Site details revised at 1 of 10 sitesv20
  3. Eligibility criteria expanded, about 19 words
    • Site contacts updated at 1 of 10 sites
    v19
  4. Site contacts updated at 1 of 10 sitesv18
  5. Primary and study completion dates: Jun 2025 to Jun 2026v17
  6. 3 versions Re-verified since Jan 23, 2024, no change to tracked fieldsv14-v16
  7. Primary and study completion dates: Jun 2024 to Jun 2025v13
  8. Re-verified, no change to tracked fieldsv12
  9. Site details revised at 1 of 10 sitesv11
  10. Re-verified, no change to tracked fieldsv10
  11. Study sites: 9 to 10v9
  12. Site details revised at 1 of 9 sitesv8
  13. Study sites: 8 to 9v7
  14. Study sites: 7 to 8v6
  15. Study sites revised (7)v5
  16. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Feb 2024 to Jun 2024
    • Start date changed from estimate of May 2022 to Jun 2, 2022
    • Site details revised at 7 of 7 sites
    v4
  17. Start date: Mar 2022 to May 2022v3
  18. Start date: Feb 2022 to Mar 2022v2
  1. Study First Submitted
  • 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 study will test whether enfortumab vedotin combined with pembrolizumab is an effective treatment for people with bladder cancer (urothelial carcinoma) involving the lymph nodes who are going to have surgery to remove their cancer (cystectomy). The researchers will look at whether treatment with enfortumab vedotin and pembrolizumab before surgery can get rid of cancer within the lymph nodes. They will also try to find out if this combination of drugs is effective at shrinking participants' cancer before their surgery. The researchers think that a combination of enfortumab vedotin and pembrolizumab may help people with this disease because both drugs are designed to help the immune system attack and kill cancer cells. The researchers think the drugs may be more effective if given in combination rather than on their own.
Trial Details
NCT Number NCT05239624
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: Astellas Pharma US, Inc., Seagen Inc., Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Urothelial Carcinoma
Related terms Carcinoma, Transitional Cell
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov