A Phase II Study of Pembrolizumab Immunotherapy as Initial Therapy for High-Risk Non-Muscle-Invasive Bladder Cancer


Full Title

Phase II Study of Pembrolizumab (MK-3475) and Bacillus Calmette-Guérin (BCG) as FirstLine Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer (NMIBC) and HighGrade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma (NMI-UTUC)


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, has been surgically removed, and has a high risk of returning.

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).

Who Can Join

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 was surgically removed without cystectomy (bladder removal) within 6 weeks of entering the study.
  • Patients may not have had prior BCG therapy, chemotherapy, or radiation therapy.
  • 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 about this study and to inquire about eligibility, please contact Dr. Dean Bajorin at 646-888-4700.