drugset / Trial / NCT06704191

In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial

NCT06704191

NaSingle-groupOpen-labelTreatment

Summary

This phase Ib/II trial compares the safety, tolerability and acceptability of intravesical chemotherapy given at home to in-clinic administration in patients with non-muscle invasive bladder cancer. Chemotherapy drugs, such as bacillus Calmette-Guerin (BCG), gemcitabine, docetaxel, and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Standard of care chemotherapy for non-invasive bladder cancer is usually given directly into the bladder through a catheter (intravesical). This process requires numerous visits and can be disruptive to the lives of patients and caregivers. Bringing cancer care to the patients with in-home intravesical therapy may help reduce the disruption to daily lives. In-home intravesical chemotherapy may be safe and tolerable and may also be preferable to in-clinic administration in patients with non-muscle invasive bladder cancer.

Timeline

Start
2025-04-21
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject BCG Unknown Intrathecal
Subject Docetaxel Small molecule Intrathecal
Subject Gemcitabine Small molecule Intrathecal
Subject Mitomycin C Other / unclassified Intrathecal