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
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
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.
Inclusion Criteria:
Exclusion Criteria:
Substudy:
- Previous diagnosis of histologically confirmed urothelial bladder carcinoma at any time prior to current qualifying diagnosis
Participate-In-This-Study1@its.jnj.com844-434-4210
Los Angeles, California 90033, United States
Orange, California 92868, United States
Aurora, Colorado 80045, United States
St Louis, Missouri 63141, United States
Raleigh, North Carolina 27612, United States
Myrtle Beach, South Carolina 29572, United States
CABA, C1425, Argentina
Córdoba, 5000, Argentina
Porto Alegre, 90050170, Brazil
São Paulo, 01221-020, Brazil
São Paulo, 01246-000, Brazil
São Paulo, 01323 900, Brazil
Cheng Du Shi, 610014, China
Cheng Du Shi, 610041, China
Wenzhou, 325000, China
Wuhan, 430032, China
Braunschweig, 38126, Germany
Amagasaki Shi, 660 8550, Japan
Kawasaki Shi, 216 8511, Japan
Kumamoto, 860 0008, Japan
Tarnów, 33-100, Poland
Wroclaw, 50 981, Poland
Chungcheongbuk Do, 28644, South Korea
Jeollanam-do, 58128, South Korea
Seoul, 06591, South Korea
Ankara, 06200, Turkey (Türkiye)
Istanbul, 34722, Turkey (Türkiye)