Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)

Inclusion Criteria:

• Participants with clinical tumour stage T2-T4aN0/1M0 or T1N1M0 with transitional ormixed transitional cell histology

• Patients must be planning to undergo radical cystectomy

• Patients who have not received prior systemic chemotherapy or immunotherapy fortreatment of muscle-invasive bladder cancer

• ECOG performance status of 0 or 1

• Minimum life expectancy of 12 weeks at first dose of study medication

Exclusion criteria:

• Evidence of lymph node (N2-N3) or metastatic (M1) disease

• Inoperable tumour(s) with fixation to the pelvic wall on clinical examination

• Prior exposure to immune-mediated therapy including, but not limited to, other antiCTLA-4, anti-PD 1, anti-PD L1 and anti-PD-L2 antibodies, excluding BacillusCalmette-Guérin

• Current or prior use of immunosuppressive medication within 14 days before the firstdose of durvalumab

• Any concomitant medication known to be contraindicated to the chemotherapy (ddMVACor gem/cis).

• Uncontrolled intercurrent illness.