A Phase 3 Study of TAR-210 Compared to Standard Treatment in People With Non-Muscle Invasive Bladder Cancer

Full Title

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

Purpose

Researchers are comparing standard bladder cancer treatment with TAR-210. The people in this study have bladder cancer that has not grown into the muscle wall. Their cancer has a mutation (change) in the FGFR gene.

The tumor has been removed through an operation called transurethral surgery of bladder tumor (TURBT). During TURBT, a surgeon removes the tumor using instruments and a thin scope inserted into the bladder through the urethra. People who have had TURBT may then have chemotherapy given intravesically (directly into the bladder).

TAR-210 is a drug delivery system inserted into the bladder. It releases the drug erdafitinib into the bladder. If you take part in this study, you will be randomly assigned to get one of these treatments:

• TAR-210
• Intravesical chemotherapy with mitomycin C or gemcitabine

 

Who Can Join

To join this study, there are a few conditions. You must:

• Have non-muscle invasive bladder cancer that was removed using TURBT and has an FGFR mutation.
• Be able to walk and do routine activities for more than half the time you are awake.
• Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Eugene Pietzak’s office at 646-422-4781.