A Phase II Study of Pembrolizumab Immunotherapy and BCG as Initial Therapy for High-Risk Non-Muscle-Invasive Bladder Cancer and Upper Tract Urothelial 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. BCG is a different kind of immunotherapy that is also used to treat bladder cancer. In this study, researchers are evaluating the safety and effectiveness of pembrolizumab and BCG to treat bladder cancer and upper tract urothelial cancers that have not invaded the muscle wall, have been surgically removed, and have 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. It is given intravenously (by vein). BCG is given directly into the bladder.

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.




Phase II (phase 2)



ClinicalTrials.gov ID