A Phase II Study of Pembrolizumab Immunotherapy for Noninvasive Bladder Cancer Persisting After BCG Therapy

Full Title

A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Subjects with High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy

Purpose

Pembrolizumab is an immunotherapy drug used to treat several types of cancer, including metastatic bladder cancer that has continued to grow despite prior treatment with platinum-containing therapy. In this study, researchers are evaluating the safety and effectiveness of pembrolizumab to treat bladder cancer that has not invaded the muscle wall and continues to grow despite prior treatment with Bacillus Calmette-Guerin (BCG, a treatment that is placed inside the bladder) and who cannot have or do not want to undergo bladder removal surgery (cystectomy).

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. Its use in this study is considered investigational. It is 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 high-risk noninvasive transitional cell carcinoma of the bladder that has grown despite prior BCG treatment.
  • Patient must either be ineligible for or have chosen not to have cystectomy.
  • 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 about this study and to inquire about eligibility, please contact Dr. Dean Bajorin at 646-888-4700.

Protocol

17-294

Phase

II

Investigator

Co-Investigators