A Phase II Study of Pembrolizumab Immunotherapy, Gemcitabine, and Radiation Therapy for Patients with Bladder Cancer

Full Title

A Phase II Trial of MK3475 in Combination with Gemcitabine and Concurrent Hypofractionated Radiation Therapy as Bladder Sparing Treatment for Muscle-Invasive Urothelial Cancer of the Bladder

Purpose

Surgery, radiation therapy, and chemotherapy are standard treatments for bladder cancer that has invaded the muscle wall. In this study, researchers want to see if giving the immunotherapy drug pembrolizumab with gemcitabine chemotherapy and radiation therapy can spare patients with muscle-invasive bladder cancer from surgery to remove the bladder. They also want to see if this treatment combination can reduce the risk of the cancer coming back.

Pembrolizumab works by blocking a molecule called PD-1 that shuts down the immune response. Blocking PD-1 can allow the immune system to detect and attack cancer cells. Pembrolizumab is already approved to treat advanced bladder cancer; its use in combination with gemcitabine and radiation therapy is considered investigational. Pembrolizumab and gemcitabine are given intravenously (by vein).

Eligibility

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

  • Patients must have muscle-invasive bladder cancer that has not yet been treated. An exception is BCG (intravesical) therapy, which is permitted if completed at least 4 weeks before entering the study.
  • Patients either may not be candidates for bladder removal surgery or must refuse this treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Marisa Kollmeier at 212-639-3952.

Protocol

18-384

Phase

II

Investigator

Co-Investigators