Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

Inclusion:

- Patient resectable muscle-invasive bladder cancer with clinical stage T2N0M0-T4aN0M0
with transitional cell histology

- Patients must be planning to undergo a radical cystectomy at the time of randomization

- Patients who have not received prior systemic chemotherapy or immunotherapy for
treatment of MIBC

- ECOG performance status of 0 or 1

- Must have a life expectancy of at least 12 weeks at randomization

Exclusion:

- Evidence of lymph node or metastatic disease at time of screening.

- Prior pelvic radiotherapy treatment

- Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin
[BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or
anti-PD-L2 antibodies.

- Current or prior use of immunosuppressive medication within 14 days before the first
dose of investigational product (IP). The following are exceptions to this criterion:
Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra
articular injection); Systemic corticosteroids at physiologic doses not to exceed 10
mg/day of prednisone or its equivalent; Steroids as premedication for hypersensitivity
reactions (eg, CT scan premedication)

- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.

- Uncontrolled intercurrent illness

- Active infection including Tuberculosis, Hepatitis B, Hepatitis C, and Human
Immunodeficiency