A Phase 2 Study of TAR-200 Plus Cetrelimab Versus Cetrelimab Alone Before Surgery in People With Bladder Cancer

Full Title

A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination with Cetrelimab and Cetrelimab Alone in Participants with Muscle-Invasive Urothelial Carcinoma of the Bladder who are Scheduled for Radical Cystectomy and are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy

Purpose

Researchers are comparing TAR-200 (gemcitabine) plus cetrelimab with cetrelimab alone to treat bladder cancer. The people in this study have bladder cancer that grew into the muscle wall. They will have a cystectomy (surgery to remove the bladder). They are unable or chose not to have chemotherapy before surgery. It is hoped that giving TAR-200 with cetrelimab will improve the results of cystectomy.

TAR-200 is a drug delivery system made of a soft pretzel-shaped tube. It is placed into the bladder and releases a controlled amount of the chemotherapy drug gemcitabine over 3 weeks. Cetrelimab helps the immune system target cancer cells and kill them. It is given intravenously (by vein).

If you join this study, you will be randomly assigned to get one of these treatments:

• TAR-200 (gemcitabine) plus cetrelimab
• Cetrelimab alone

Who Can Join

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

• Have muscle-invasive bladder cancer that will not be treated with platinum-based chemotherapy before surgery.
• Be planning to have a cystectomy.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Alvin Goh’s office at 646-422-4667.