A Phase 3 Randomized Open-Label Three Arm Study of PF-06801591 in Combination with BCG (Induction With or Without Maintenance) Versus BCG (Induction and Maintenance) in Participants with HR BCG-Na ve NMIBC (B8011006) | NYU Langone Health

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A Phase 3 Randomized Open-Label Three Arm Study of PF-06801591 in Combination with BCG (Induction With or Without Maintenance) Versus BCG (Induction and Maintenance) in Participants with HR BCG-Na ve NMIBC (B8011006)

Are you eligible to participate in this study?

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

Conditions:
Nmibc
Age: Between 18 years - 100 years
Gender: Male or Female

Other Inclusion Criteria:

1) Histological confirmed diagnosis of high-risk, non-muscle invasive transitional cell carcinoma (TCC) of the urothelium of the urinary bladder (tumors of mixed transitional/non-transitional cell histology are allowed, but TCC must be the predominant histology); defined as any of the following: a. T1 tumor; b. High-grade Ta tumor; c. Carcinoma in situ (CIS).

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

1) Evidence of muscle-invasive, locally advanced or metastatic urothelial cancer or concurrent extravesical, non-muscle invasive TCC of the urothelium. 2) Severe active infections including pulmonary tuberculosis requiring systemic therapeutic oral or IV antibiotics within 2 weeks prior to randomization.