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
Single group
Durvalumab
DrugAnti- PD-L1 Antibody.
Methotrexate
DrugChemotherapy agent.
Vinblastine
DrugChemotherapy agent
Doxorubicin
DrugChemotherapy agent
Cisplatin
DrugChemotherapy agent
Durvalumab
DrugAnti- PD-L1 Antibody
Gemcitabine
DrugChemotherapy agent
Cisplatin
DrugChemotherapy agent
The safety of neoadjuvant durvalumab combined with ddMVAC or gem/cis prior to radical cystectomy (RC).
Incidence of Grade 3 or 4 \[possibly treatment-related adverse events (PRAEs)\] as observed prior to RC.
The safety and tolerability of perioperative durvalumab combined with ddMVAC or gem/cis.
Incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality of treatment-emergent adverse events, including PRAEs, adverse events of special interest, immune-mediated adverse events, adverse events (AEs), and serious adverse events; AEs resulting in study treatment interruption and discontinuation; laboratory findings.
The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of event-free survival (EFS).
EFS is defined as the time from first neoadjuvant durvalumab + chemotherapy treatment until the earliest occurrence of any of the following events: * First recurrence of disease after RC * First documented progression in participants who were medically precluded from RC * Time of expected surgery in participants who refuse to undergo RC or failure to undergo RC in participants with residual disease * Death due to any cause.
The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of disease-free survival (DFS).
DFS is defined as the time from the date of RC to the earliest of the first recurrence of disease post RC or death due to any cause.
The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of OS.
OS is defined as the time from first neoadjuvant durvalumab + chemotherapy until death due to any cause.
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