BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Treatment Study

Clinical Trial Title

A031803: Phase II Trial of Intravesical Gemcitabine and MK-3475 (Pembrolizumab) in the Treatment of Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

National Clinical Trial Number:

NCT04164082

Clinical Trial Protocol Description:

This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Drugs used in chemotherapy, such as gemcitabine, work in different ways by stopping the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine may delay the return of BCG-unresponsive bladder cancer for longer period compared to gemcitabine alone.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Have high grade Ta, T1 or CIS urothelial carcinoma.
  • Have persistent disease after completing therapy with at least induction BCG (>= 5 doses) and the first round of maintenance or second induction course (>= 2 doses).
  • Are not pregnant or nursing.
  • Have not received any prior bladder radiation.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Srinivas Vourganti, MD

Contact Information

Rush Cancer Center Clinical Trials Office