A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations
Janssen Research & Development, LLC
Summary
The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Main study only: Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c. Greater than or equal to (\>=) 1 of the following risk factors: i. Multiple Ta LG tumors, ii. Solitary LG tumor \>= 3 cm, iii. Early recurrence (less than \[\<\] 1 year), iv. Frequent recurrence (greater than \[\>\] 1 per year), v. Recurrence after prior adjuvant intravesical treatment (single perioperative dose of c…
Interventions
- Combination ProductTAR-210
TAR-210 will be administered intravesically.
- DrugGemcitabine
Gemcitabine will be administered intravesically.
- DrugMMC
MMC will be administered intravesically.
Locations (193)
- Arkansas UrologyLittle Rock, Arkansas
- Genesis Research LLCLos Alamitos, California
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- University of California Irvine Medical CenterOrange, California
- Om Research LLCSan Diego, California
- Genesis Research LLC 1Sherman Oaks, California