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

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