A Phase II Study of Pembrolizumab Immunotherapy Added to Gemcitabine Given into the Bladder to Treat Non-Muscle Invasive Bladder Cancer that Persists Despite BCG Therapy

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Full Title

Phase II Trial Of Intravesical Gemcitabine and Mk-3475 (Pembrolizumab) In The Treatment Of Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (A031803) (CIRB)

Purpose

Bacillus Calmette-Guerin (BCG) is a form of immunotherapy that is a standard treatment for patients with bladder cancer that has not grown beyond the lining of the bladder (non-muscle invasive bladder cancer) and has been surgically removed. But sometimes the cancer continues to grow. Patients may then have bladder removal surgery (cystectomy) or receive the chemotherapy drug gemcitabine given directly into the bladder (“intravesical therapy”).

In this study, researchers want to see if giving pembrolizumab immunotherapy in addition to intravesical therapy improves the effectiveness of treatment in patients with non-muscle invasive bladder cancer that does not respond to BCG. Pembrolizumab works by taking the brakes off the immune response, enabling immune cells to find and destroy cancer cells. It is given intravenously (by vein). Patients in this study will receive both intravesical gemcitabine and intravenous pembrolizumab.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have non-muscle invasive bladder cancer that continues to grow despite BCG therapy.
  • Patients may not be candidates for cystectomy.
  • Patients may not have received previous treatment with chemotherapy, immunotherapy, or radiation therapy to the bladder.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Eugene Pietzak at 646-422-4781.

Protocol

20-251

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators