BCG in combination with durvalumab in adult BCG-naïve, high-risk NMIBC participants - PATAPSCO

Exclusion Criteria

• • Evidence of muscle-invasive, locally advanced, metastatic, and/or extra-vesical bladder cancer (ie, T2, T3, T4, and / or Stage IV).
• • Predominantly variant histology such as micropapillary, plasmacytoid, nested, sarcomatoid, microcystic, squamous and adeno variants of UC representing > 50% of tumor tissue or other than urothelial tumors as assessed by pathology.
• • Evidence of lymphovascular invasion of bladder tumor, except if treatment with BCG is deemed to be the only clinically viable treatment.
• • Immediate cystectomy is indicated.
• • Known or documented absolute and/or relative contraindication of adjuvant intravesical BCG treatment.
• • Concurrent extravesical, non-muscle-invasive transitional cell carcinoma of the urothelium.
• • History of allogenic organ transplantation. Participants with any history of allogenic stem cell transplantation are also excluded.
• • Active or prior documented autoimmune or inflammatory disorders.
• • Participants with hypothyroidism stable on hormone replacement.
• • History of active primary immunodeficiency.
• • Active infection including hepatitis B (known positive HBV/HBsAg result), HCV, or HIV 1/2 (positive HIV) antibodies.
• • Current or prior use of immunosuppressive medication within 14 days before the first durvalumab dose.
• • Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to employ highly effective birth control.
• • Any concurrent chemotherapy, study intervention, biologic or hormonal therapy for cancer treatment; uncontrolled intercurrent illness;
• • History of another primary malignancy except for Malignancy treated with curative intent and with no known active disease ≥ 2 years; Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated CIS
• without evidence of disease; Prostate cancer of stage ≤ T2cN0M0 without biochemical recurrence or progression that in the opinion of the Investigator does not require active intervention.
• • Previous or concurrent treatment with potent systemic immunostimulatory agents