Clinical Trials

Inclusion Criteria:

- BCG-naïve (defined as participants not having received prior intravesical BCG or who previously received but stopped BCG more than 3 years before study entry).

- Local histological confirmation (based on cytology and/or pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa.

- Complete resection of all Ta/T1 papillary disease prior to enrollment, with the transurethral resection of bladder tumor (TURBT) removing high-risk NMIBC (non-muscle invasive bladder cancer) performed not more than 4 months before enrollment in the study.

- No prior radiotherapy for bladder cancer.

- A life expectancy of at least 12 weeks (90 days).

- Adequate organ and marrow function

- World Health Organization/Eastern Cooperative Oncology Group performance status of 0 or 1 at screening

- No prior exposure to immune-mediated therapy of cancer

- A candidate for BCG treatment.

- Local histological confirmation (based on cytology and/or pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa. A high-risk tumor is defined as one of the
following: T1 tumor; High-grade/G3 tumor; CIS.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/31/24.  Questions regarding updates should be directed to the study team contact.