Clinical Trial

Intravesical BCG vs GEMDOCE in NMIBC

Study acronym: BRIDGE
Active, Not Recruiting Phase 3
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Summary
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.
Protocol Amendment History 23 amendments
This ClinicalTrials.gov record has been amended 23 times since 2022-09-09; most recent amendment 2026-07-16.
Status change: Recruiting → Active, Not Recruiting 2026-01-26
Status change: Not Yet Recruiting → Recruiting 2023-01-12
Trial Details
NCT Number NCT05538663
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Conditions Non-muscle-invasive Bladder Cancer
Enrollment 870 participants
Start Date 2023-02-07
Primary Completion 2029-11-01 (estimated)
Study Completion 2030-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-17