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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    High Risk, Non-muscle Invasive Bladder Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:

    1. Patients must have been diagnosed with high risk non-muscle-invasive (T1, high grade Ta and / or carcinoma in situ) transitional cell carcinoma of the bladder

    2. Absence of resectable disease after at least 2 cystoscopy /transurethral resection (TURBT) procedures (residual CIS acceptable)

    3. BCG-unresponsive high risk non-muscle-invasive bladder cancer after treatment with adequate BCG therapy

    4. Ineligible for radical cystectomy or refusal of radical cystectomy


You may not be eligible for this study if the following are true:

  • 1.  Patients with muscle invasive (T2, T3, or T4) locally advanced non-resectable or metastatic urothelial carcinoma

     

    2.  Patient has concurrent extra-vesical non-muscle invasive transitional cell carcinoma of the urothelium

     

    3.  Evidence of Interstitial lung disease or active non-infectious pneumonitis

     

    4.  Pregnancy or lactation




If you are registered as a volunteer, please log in to contact the study team/express interest in this study.