Urology San Antonio has enrolled the first patient in the United States for a new clinical trial that investigates treatment for muscle invasive bladder cancer (MIBC).
Investigators include Urologic Oncologist Dr. Daniel Zainfeld (Principal Investigator) and Medical Oncologist Dr. Rohit Kapoor. The trial is coordinated through Urology San Antonio’s Clinical Trials Department.
This clinical trial is trying to find out if study drugs given together, before and after surgery, can help to improve the treatment of MIBC compared to chemotherapy before surgery.
What Is Bladder Cancer?
Bladder cancer begins in the cells which make up the bladder, a hollow elastic organ that holds urine made by the kidneys until it is emptied from the body through the urethra. Most commonly, bladder cancer develops in the cells which line the inner surface of the bladder – these cells are called urothelial cells. This means that the most common kind of bladder cancer is called urothelial cancer. Urothelial cancer can develop anywhere along the urinary tract (e.g. inner lining of kidneys, ureters, bladder, urethra), but most frequently occurs in the bladder itself.
What is Muscle Invasive Bladder Cancer (MIBC)?
MIBC are tumors located in the bladder. These tumors have grown from the inner surface lining of the bladder into the deeper muscle layers, which is why they are called “Muscle Invasive.”
How is Muscle Invasive Bladder Cancer (MIBC) treated?
After diagnosis, the tumor is removed by a procedure called a Transurethral Resection of Bladder Tumor (TURBT), if it was not already removed during the initial biopsy to determine the diagnosis. Chemotherapy may then be used to treat any cancer cells which may have spread beyond the bladder and to prevent the cancer from coming back. A surgery called a Radical Cystectomy (RC) and Pelvic Lymph Node Dissection (PLND) will follow chemotherapy. In males, a Radical Cystectomy includes the removal of the bladder, prostate, and seminal vesicles. In females, a Radical Cystectomy includes the removal of the bladder along with the uterus, fallopian tubes, ovaries, and anterior vaginal wall.
What is a clinical trial?
Clinical trials are research studies that help doctors find out if study drugs (alone or with other treatments) are safe and if they can help prevent or treat diseases or other conditions.
Why is this clinical trial being done?
This clinical trial is trying to find out if study drugs given together, before and after surgery, are safe and work to help improve the treatment of patients with MIBC compared to chemotherapy before surgery. It is not known if these study drugs will work to treat MIBC in this setting.
What treatments are being studied?
One drug being studied is an investigational medication (study drug) called pembrolizumab (also known as MK-3475). Pembrolizumab is a type of immunotherapy, which may help the body’s immune system attack cancer cells. The other drug being studied is an investigational medication (study drug) called enfortumab vedotin (also known as EV). Enfortumab vedotin is an antibody-drug conjugate (ADC) and it is designed for the treatment of cancer cells by delivering drug directly to the tumor.
Who can join this study?
There are certain requirements that you must meet in order to join. Your study team will perform certain tests that will help them determine if you are eligible to join. This study will include people with MIBC who are:
- Eligible to receive cisplatin-based chemotherapy; AND
- Planning to have a Radical Cystectomy and PLND surgery
You and your study doctor will discuss the requirements to decide if this study is a good option for you, as well as the possible benefits and risks of joining this study. Before deciding to participate, you should make sure you understand the potential side effects or risks of participating in the study. These will be explained to you by the study doctor. If there is anything you do not understand, you are encouraged to ask the study doctor.
How to get more Information
About Urology San Antonio Clinical Trials
Urology San Antonio has over 18 years of experience conducting urology clinical trials. Conveniently located in San Antonio’s Medical Center, our research facility conducts Phase I, II, III, and IV clinical research studies. Together, our certified Research Coordinators, Investigators, and sponsors help develop better medications and treatments for patients around the world.