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Intravesical BCG vs GEMDOCE in NMIBC

Study acronym: BRIDGE
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Eligibility criteria expanded, about 20 words
    • Site details revised at 17 of 229 sites
    • Publications: details revised at 3 of 3 entries
  2. 5 versions Re-verified since Feb 27, 2026, no change to tracked fieldsv20-v24
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 229 of 229 sites
    v19
  4. 4 versions Re-verified since Sep 15, 2025, no change to tracked fieldsv15-v18
  5. Site details revised at 1 of 229 sitesv14
Show 12 earlier versionsHide 12 earlier versions
  1. Re-verified, no change to tracked fieldsv13
  2. Study sites: 187 to 229v12
  3. Study sites: 175 to 187v11
  4. Study sites: 143 to 175v10
  5. Primary completion date: Nov 2029 to Nov 1, 2029v9
  6. Study sites: 116 to 143v8
  7. Study sites: 1 to 116v7
  8. Start date: Dec 1, 2022 to Feb 7, 2023v6
  9. Re-verified, no change to tracked fieldsv5
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2022 to Dec 1, 2022
    v4
  11. Lead sponsor: Eastern Cooperative Oncology Group to ECOG-ACRIN Cancer Research Groupv3
  12. Start date: Oct 2022 to Nov 2022v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior event-free survival (EFS) compared to standard treatment with intravesical BCG. The purpose of this study is to test whether Gemcitabine + Docetaxel is a better or worse treatment than the usual BCG therapy approach. The primary objective of this study is to determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as follows: to compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE, to determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, to determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, and to determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.
Trial Details
NCT Number NCT05538663
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Non-muscle-invasive Bladder Cancer
Related terms Non-Muscle Invasive Bladder Neoplasms
Enrollment 870 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov