The Phase IIIb NIAGARA-2 study aims to expand on the data from the Phase III NIAGARA study by investigating perioperative durvalumab in combination with investigator-selected cisplatin-based neoadjuvant chemotherapy (either ddMVAC or gemcitabine/cisplatin) in a clinical practice setting.
Participants with clinical tumour stage T2-T4aN0/1M0 or T1N1M0 with transitional or mixed transitional cell histology
Patients must be planning to undergo radical cystectomy
Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of muscle-invasive bladder cancer
ECOG performance status of 0 or 1
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 anti CTLA-4, anti-PD 1, anti-PD L1 and anti-PD-L2 antibodies, excluding Bacillus Calmette-Guérin
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab
AstraZeneca
Lead sponsor