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

A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

Inclusion: * Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology * Patients must be planning to undergo a radical cystectomy * 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 (N2-N3) or metastatic (M1) disease at time of screening. * Prior pelvic radiotherapy treatment within 2 years of randomization to study * 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