NIAGARA-2 / D933RC00002
NIAGARA-2 / D933RC00002: Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer
Trial summary:
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.
Receptor status / problem studied:
Inclusion criteria
1) Participants with clinical tumour stage T2-T4aN0/1M0 or T1N1M0 with transitional or mixed transitional cell histology.
2) Patients must be planning to undergo radical cystectomy.
3) Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of muscle-invasive bladder cancer.
4) ECOG performance status of 0 or 1.
5) Minimum life expectancy of 12 weeks at first dose of study medication.
Exclusion criteria
1) Evidence of lymph node (N2-N3) or metastatic (M1) disease.
2) Inoperable tumour(s) with fixation to the pelvic wall on clinical examination.
3) 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.
4) Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
5) Any concomitant medication known to be contraindicated to the chemotherapy (ddMVAC or gem/cis).
6) Uncontrolled intercurrent illness.
Trial Title
NIAGARA-2 / D933RC00002
Diagnosis
Bladder cancer
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
III