A Study of Two Dosing Schedules of Atezolizumab in Combination With Gemcitabine and Cisplatin as First-Line Treatment for Metastatic Bladder Cancer

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Trial completed
    • Primary completion date changed from estimate of Mar 2027 to Sep 22, 2026
    • Eligibility criteria expanded, about 74 words
    • Site details revised at 2 of 9 sites
  2. Primary and study completion dates: Mar 2026 to Mar 2027v26
  3. Primary and study completion dates: Mar 2025 to Mar 2026v25
  4. Re-verified, no change to tracked fieldsv24
  5. Primary and study completion dates: Mar 2024 to Mar 2025v23
Show 21 earlier versionsHide 21 earlier versions
  1. Primary and study completion dates: Mar 2023 to Mar 2024
    • Study sites revised (9)
    v22
  2. 2 versions Re-verified since Jan 14, 2022, no change to tracked fieldsv20-v21
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 74 to confirmed 32
    • Site details revised at 9 of 9 sites
    v19
  4. Primary and study completion dates: Mar 2022 to Mar 2023v18
  5. Primary and study completion dates: Mar 2021 to Mar 2022v17
  6. 2 versions Re-verified since Apr 6, 2020, no change to tracked fieldsv15-v16
  7. Study sites revised (9)v14
  8. Primary and study completion dates: Mar 2020 to Mar 2021
    • Study sites: 8 to 9
    v13
  9. Study sites: 6 to 8
    • Eligibility criteria expanded, about 10 words
    v12
  10. Trial status: Suspended to Recruitingv11 Show 6 more changesShow less
    • Enrollment target: 31 to 74
    • Primary and study completion dates: Mar 2019 to Mar 2020
    • Primary endpoint revised
    • Eligibility criteria expanded, about 12 words
    • Site details revised at 6 of 6 sites
    • Study arms: 2 to 3
  11. Trial status: Recruiting to Suspended Sponsor's reason: Safety Related
    • Site details revised at 6 of 6 sites
    v10
  12. Re-verified, no change to tracked fieldsv9
  13. Study sites: 5 to 6v8
  14. Collaborators: 3 to 4
    • Eligibility criteria expanded, about 2 words
    v7
  15. Re-verified, no change to tracked fieldsv6
  16. Study sites: 4 to 5v5
  17. Study sites: 3 to 4
    • Eligibility criteria shortened, about 11 words
    v4
  18. Site details revised at 1 of 3 sitesv3
  19. Collaborators: 2 to 3v2
  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.
The purpose of this study is to compare any good and bad effects the study drug atezolizumab has on the cancer when combined with the standard chemotherapy drugs gemcitabine and cisplatin (or GC) in two different dosing schedules: chemotherapy (GC) before atezolizumab vs. GC after atezolizumab.
Trial Details
NCT Number NCT03093922
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: Ohio State University, University of Chicago, Genentech, Inc., Targos
Conditions
(from sponsor)		 Urothelial Carcinoma, Locally Advanced, Unresectable
Related terms Carcinoma, Transitional Cell
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov