Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination with Cetrelimab TAR-200 Alone or Cetrelimab Alone in Participants with High-Risk Non- Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guerin (BCG) who are Ineligible for or Elected Not to Undergo Radical Cystectomy

Are you eligible to participate in this study?

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

  • Conditions:
    Bladder Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Histologically confirmed diagnosis of high-risk, non-muscle invasive urothelial carcinoma in situ (CIS; Tis), with or without papillary disease (T1, high-grade Ta) within 12 months of completion of adequate Bacillus Calmette-Guerin (BCG) therapy. 2) For participants with lamina propria invasion (T1) on the screening biopsy/ transurethral resection of bladder tumor (TURBT), muscularis propria must be present in order to rule out Muscle Invasive Bladder Cancer (MIBC). 3) Visible papillary disease must be fully resected (absent) prior to randomization (residual CIS acceptable) and documented at screening cystoscopy.

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

  • 1) Histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV. 2) Concurrent extra-vesical (that is, urethra, ureter, or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium. 3) Participants with an active, known or suspected autoimmune disease.


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