Intravesical BCG vs GEMDOCE in NMIBC

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.

Timeline

Start

2023-02-07

Primary completion

2029-11-01

Completion

2030-10

Publications

• Koti M, Robert Siemens D. A Step Closer to Predicting Progression After Bacillus Calmette-Guerin Immunotherapy in High-risk Non-muscle-invasive Bladder Cancer. Eur Urol. 2023 Nov;84(5):447-448. doi: 10.1016/j.eururo.2023.06.017. Epub 2023 Jul 1.

Drugs

Indications