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A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion pushed from Jun 2026 to Nov 2026v17
  2. Primary completion date: Jan 2028 to Jun 2026
    • Study completion date: Jan 2030 to Feb 2029
    • Secondary endpoints revised (2)
    • Study sites revised (95)
    v16
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 364 to confirmed 367
    • Site details revised at 95 of 95 sites
    v15
  4. Study sites: 94 to 95v14
  5. Study sites: 88 to 94
    • Secondary endpoints: details revised at 1 of 2 entries
    • Eligibility criteria shortened, about 2 words
    • Study description expanded, about 1 word
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 78 to 88v12
  2. Study sites: 75 to 78v11
  3. Study sites: 73 to 75v10
  4. Study sites: 71 to 73v9
  5. Study sites: 62 to 71v8
  6. Study sites: 48 to 62v7
  7. Study sites: 47 to 48v6
  8. Study sites: 32 to 47v5
  9. Enrollment target: 426 to 364
    • Study sites: 10 to 32
    • Eligibility criteria revised
    v4
  10. Study sites: 1 to 10v3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2023 to Dec 14, 2023
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.
Trial Details
NCT Number NCT06111235
Lead Sponsor CG Oncology, Inc.
Conditions
(from sponsor)		 Non Muscle Invasive Bladder Cancer, Urologic Cancer, Bladder Cancer, Urothelial Carcinoma
Related terms Carcinoma, Transitional Cell, Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms, Urologic Neoplasms
Enrollment 367 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov