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Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

Study acronym: BOND-003
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv34
  2. Primary completion date: Dec 24, 2027 to Jun 16, 2030
    • Study sites: 72 to 86
    • Study completion date: Dec 24, 2029 to Dec 24, 2031
    v33
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 72 of 72 sites
    v32
  4. Re-verified, no change to tracked fieldsv31
  5. Study sites: 73 to 72v30
Show 28 earlier versionsHide 28 earlier versions
  1. Study sites: 64 to 73v29
  2. Study sites: 61 to 64
    • Eligibility criteria revised
    v28
  3. Enrollment target: 110 to 190v27 Show 10 more changesShow less
    • Primary completion date: Jan 31, 2024 to Dec 24, 2027
    • Primary endpoints: 1 to 2
    • Study sites: 71 to 61
    • Study completion date: Jul 31, 2025 to Dec 24, 2029
    • Interventions: CG0070 (Biological), n-dodecyl-B-D-maltoside (Other) to Cretostimogene Grenadenorepvec (Biological), n-dodecyl-B-D-maltoside (Other)
    • Eligibility criteria expanded, about 718 words
    • Secondary endpoints: 5 to 8
    • Study description expanded, about 52 words
    • Study title revised
    • Study arms: 1 to 2
  4. Study sites: 69 to 71v26
  5. Primary completion date: Dec 2022 to Jan 31, 2024
    • Study sites: 59 to 69
    • Study completion date: Dec 2024 to Jul 31, 2025
    v25
  6. Study sites: 53 to 59v24
  7. Study sites: 54 to 53v23
  8. Site details revised at 1 of 54 sitesv22
  9. Study sites: 53 to 54v21
  10. Re-verified, no change to tracked fieldsv20
  11. Study sites: 52 to 53v19
  12. Study sites: 46 to 52v18
  13. Site details revised at 1 of 46 sitesv17
  14. Study sites: 41 to 46v16
  15. Site contacts updated at 2 of 41 sitesv15
  16. Study sites: 34 to 41v14
  17. Site details revised at 1 of 34 sitesv13
  18. Study sites revised (34)v12
  19. Study sites: 33 to 34v11
  20. Study sites: 32 to 33v10
  21. Re-verified, no change to tracked fieldsv9
  22. Study sites: 31 to 32v8
  23. Site details revised at 1 of 31 sitesv7
  24. Study sites revised (31)v6
  25. Study sites: 2 to 31v5
  26. Study title revisedv4
  27. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Sep 2020 to Oct 27, 2020
    v3
  28. Eligibility criteria revisedv2
  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, single arm trial designed to evaluate Cretostimogene patients with NMIBC who have failed prior BCG therapy. Up to approximately 115 CIS bladder cancer patients with or without HG Ta or HG T1 papillary disease will be enrolled under the original protocol through Amendment 4, which will comprise Cohort C. Cohort C is closed to enrollment. Under Amendment 5-1, Cohort P was added to enroll up to 70 patients with HG Ta/T1 papillary bladder cancer. Under Amendment 6, the target number of patients enrolled in Cohort P was increased to 75. Cohort P is open to enrollment Cohort C and Cohort P will be analyzed and reported separately. Patients will have had to fail prior BCG therapy which is defined as having persistent or recurrent disease within 12 months (Cohort C) or 6 months (Cohort P) following the completion of adequate BCG therapy for HGUC
Trial Details
NCT Number NCT04452591
Lead Sponsor CG Oncology, Inc.
Conditions
(from sponsor)		 Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer
Related terms Carcinoma in Situ, Non-Muscle Invasive Bladder Neoplasms
Enrollment 190 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov