NIAGARA: This phase III trial is looking at the safety and effectiveness of giving an immunotherapy (Durvalumab) in combination with chemotherapy (Gemcitabine and Cisplatin) in patients with muscle-invasive bladder cancerA Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer

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