A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)

PHASE3RecruitingINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

April 11, 2025

Primary Completion Date

April 30, 2028

Study Completion Date

April 30, 2028

Conditions
Non-Muscle Invasive Bladder Cancer
Interventions
DRUG

Nadofaragene Firadenovec

For patients randomized to receive nadofaragene firadenovec, the patient will receive nadofaragene firadenovec as of normal saline instilled intravesically every 3 months for up to 12 months.

DRUG

Gemcitabine

gemcitabine instilled intravesically for 1 h, then drained completely out of the bladder

DRUG

Docetaxel

followed by docetaxel instilled intravesically for 1 h. This is given once weekly for 6 weeks for induction. Those who have a complete response typically proceed with once-monthly instillations of GemDoce for up to 24 months as maintenance therapy

Trial Locations (1)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER