Tests durvalumab with chemotherapy before surgery for bladder cancer
Tests durvalumab with chemotherapy before and after surgery in adults with muscle-invasive bladder cancer.
Plain-language title generated from the registry record
Registry title: Perioperative Durvalumab With Neoadjuvant ddMVAC in Patients With Muscle-Invasive Bladder Cancer (NIAGARA-2)
Key facts
- Where
- Florence, Orbassano, and Rome, ItalySee the 3 sites
- Phase
- Phase 2
Where in Italy
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, ItalyTaking people
- I.F.O. Istituti Fisioterapici OspitalieriRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06960577EU 2024-519246-75-01
- Record updated
- 8 October 2026
- Original description
The Phase II NIAGARA-2 study aims to expand on the data from the Phase III NIAGARA study by investigating perioperative durvalumab in combination with cisplatin based neoadjuvant chemotherapy in a clinical practice setting.Read full original descriptionShow less
An Open-label, Single-arm, Global Study of Perioperative Durvalumab With Cisplatin-based Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer (NIAGARA-2)
The Phase II NIAGARA-2 study aims to expand on the data from the Phase III NIAGARA study by investigating perioperative durvalumab in combination with cisplatin based neoadjuvant chemotherapy in a clinical practice setting.
Inclusion: Participants with clinical tumour stage T2-T4aN0/1M0 or T1N1M0 with transitional or mixed transitional cell histology; Participants must be planning to undergo radical cystectomy; Participants 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.
Exclusion: 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 with ddMVAC; Evidence of lymph node (N2-N3) or metastatic (M1) disease; Uncontrolled intercurrent illness; Inoperable tumour(s) with fixation to the pelvic wall on clinical examination.