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
- Barcelona, Girona, Las Palmas de Gran Canaria, Lugo, Madrid, and Santiago de Compostela, SpainSee the 10 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with muscle-invasive bladder cancer who plan to have the bladder removed and have not had chemotherapy or immunotherapy for it.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Muscle-invasive bladder cancer, clinical tumour stage T2-T4aN0/1M0 or T1N1M0, with transitional or mixed transitional cell type.
- Earlier treatment
- Must not have had chemotherapy or immunotherapy for muscle-invasive bladder cancer. Must be planning radical cystectomy (bladder removal surgery).
Main reasons for not taking part
- Cancer in lymph nodes (N2-N3) or spread to other organs (M1)
- Tumour that cannot be operated on and is fixed to the pelvic wall
- Earlier immune-mediated therapy such as anti CTLA-4, anti-PD 1, anti-PD L1 or anti-PD-L2 antibodies (Bacillus Calmette-Guérin is allowed)
- Immunosuppressive medicine within 14 days before the first dose of durvalumab
- Uncontrolled other illness
Read by machine on 12 November 2026.
Where in Spain
- Hospital Clinic de BarcelonaBarcelona, SpainTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- Hospital del MarBarcelona, SpainTaking people
- Vall d'Hebron Institute of OncologyBarcelona, SpainTaking people
- Institut Català d'OncologiaGirona, SpainTaking people
- Complejo Hospitalario Universitario Insular Materno InfantilLas Palmas de Gran Canaria, SpainTaking people
- Hospital Universitario Lucus AugustiLugo, SpainTaking people
- Hospital Clínico San CarlosMadrid, SpainTaking people
- MD Anderson Cancer CenterMadrid, SpainTaking people
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpainTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.