Intravesical BCG vs GEMDOCE in NMIBC (NCT05538663)
A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (229 Sites)
Showing the first 25 of 229 sites.
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
- Fairbanks Memorial Hospital — Fairbanks, Alaska
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- CTCA at Western Regional Medical Center — Goodyear, Arizona
- Cancer Center at Saint Joseph's — Phoenix, Arizona
- Mercy Hospital Fort Smith — Fort Smith, Arkansas
- CARTI Cancer Center — Little Rock, Arkansas
- Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California
- Mercy Cancer Center - Carmichael — Carmichael, California
- Mercy San Juan Medical Center — Carmichael, California
- Mercy Cancer Center - Elk Grove — Elk Grove, California
- UC San Diego Moores Cancer Center — La Jolla, California
- Los Angeles General Medical Center — Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California
- Contra Costa Regional Medical Center — Martinez, California
- Mercy Cancer Center — Merced, California
- Mercy Cancer Center - Rocklin — Rocklin, California
- Mercy Cancer Center - Sacramento — Sacramento, California
- UCSF Medical Center-Mission Bay — San Francisco, California
- Pacific Central Coast Health Center-San Luis Obispo — San Luis Obispo, California
- Mission Hope Medical Oncology - Santa Maria — Santa Maria, California
- BASS Medical Group - Lennon — Walnut Creek, California
- Woodland Memorial Hospital — Woodland, California
- Rocky Mountain Cancer Centers-Aurora — Aurora, Colorado
- UCHealth University of Colorado Hospital — Aurora, Colorado
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Non-muscle-invasive Bladder Cancer
- Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer — Auchenflower,
- A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer — Little Rock, Arkansas
- Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance — West Haven, Connecticut
- Artificial Intelligence Prediction Tool in Non-muscle Invasive Bladder Cancer (NMIBC) — Dallas, Texas
- A Phase I Intravesical PPM Therapy for NMIBC — Boston, Massachusetts
Explore by condition: All Non-muscle-invasive Bladder Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.