Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
Recruiting now Phase 3 NCT06960577
Run by AstraZeneca · for 18 and older · All sexes
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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
- Minimum life expectancy of 12 weeks at first dose of study medication
🚫 You may not be able to join if…
- 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
- Any concomitant medication known to be contraindicated to the chemotherapy (ddMVAC or gem/cis).
- Uncontrolled intercurrent illness.
Where this trial is running
- Research Site, Chermside, Australia
- Research Site, Elizabeth Vale, Australia
- Research Site, Heidelberg, Australia
- Research Site, Hong Kong, Australia
- Research Site, Kogarah, Australia
- Research Site, Macquarie University, Australia
- Research Site, Murdoch, Australia
- Research Site, Port Macquarie, Australia
- Research Site, St Leonards, Australia
- Research Site, Barretos, Brazil
- Research Site, Jaú, Brazil
- Research Site, Natal, Brazil
+ 47 more sites.
Who to contact
AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06960577.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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