A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)
Summary
The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
Arms & interventions
- DrugTAR-210
TAR-210 will be administered intravesically.
- DrugMitomycin C
MMC will be administered intravesically.
- DrugGemcitabine
Gemcitabine will be administered intravesically.
Outcome measures
Primary
Disease-free Survival (DFS)
DFS is measured as the time from randomization to the date of the first recurrence of HR-NMIBC (high-grade Ta, any T1 or carcinoma in situ \[CIS\]), progression, or death due to any cause, whichever occurs first.
Time frame: Up to 5 years
Secondary
Recurrence-Free Survival (RFS)
Time frame: Up to 5 years
Time to Next Intervention (TTNI)
Time frame: Up to 5 years
Time to Disease Worsening (TTDW)
Time frame: Up to 5 years
Time to Progression (TTP)
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time frame: Up to 5 years
Number of Participants With Change from Baseline in Laboratory Abnormalities
Time frame: Up to 5 years
Number of Participants With Change from Baseline in Vital Signs Abnormalities
Time frame: Up to 5 years
Change from Baseline in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-C30 Scores
Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96
Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96
Percentage of Participants With Meaningful Change From Baseline in EORTC-QLQ-C30 Scores
Time frame: Weeks 12, 24, 36, 48, 60, 72, 84 and 96
Percentage of Participants With Meaningful Change From Baseline in EORTC-QLQ-NMIBC24 Scores
Time frame: Weeks 12, 24, 36, 48, 60, 72, 84 and 96
Number of Participants with Overall Side Effects Measured by EORTC Question 168 (Q168)
Time frame: Up to Week 96
Eligibility criteria
Study locations (22)
Academic Urology and Urogynecology of Arizona
Sun City, Arizona, 85351
Colorado Clinical Research
Lakewood, Colorado, 80228
Georgia Urology
Atlanta, Georgia, 30328
Associated Urological Specialists
Chicago Ridge, Illinois, 60415
Urology of Indiana
Carmel, Indiana, 46032
Greater Boston Urology
Plymouth, Massachusetts, 02360
Comprehensive Urology
Royal Oak, Michigan, 48073
UroHealth Partners
Omaha, Nebraska, 68114
New Jersey Urology LLC
Voorhees Township, New Jersey, 08043
Associated Medical Professionals
Syracuse, New York, 13210
Dayton Physicians Network Urology
Centerville, Ohio, 45459
The Urology Group
Cincinnati, Ohio, 45212
Helios Clinical Research, LLC
Middleburg Heights, Ohio, 44130
Oregon Urology Institute
Springfield, Oregon, 97477
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
Keystone Urology Specialists
Lancaster, Pennsylvania, 17604
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
The Conrad Pearson Clinic
Germantown, Tennessee, 38138
Texas Oncology-Austin
Austin, Texas, 78731
Urology Austin
Austin, Texas, 78745
Urology San Antonio PA dba USA Clinical Trials
San Antonio, Texas, 78229