drugset / Trial / NCT04179162

Bacillus Calmette-Guérin (BCG) and Gemcitabine in People With High-Grade Non-Muscle Invasive Bladder Cancer That Came Back After BCG Treatment

NCT04179162

Phase 1/2 Active not recruiting 54 enrolled Memorial Sloan Kettering Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

This study will test the safety of BCG and gemcitabine in people who have BCG-relapsing Non-Muscle Invasive Bladder Cancer (NMIBC). The researchers will test increasing doses of gemcitabine to find the highest dose that causes few or mild side effects when combined with BCG. The study will also look at whether this combination of drugs is effective in treating BCG-relapsing NMIBC.

Timeline

Start
2019-11-22
Primary completion
2027-11
Completion
2027-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule Other
Background Bacillus Calmette-Guérin Vaccine 50 mg Other