Tests durvalumab with chemotherapy before surgery for bladder cancer
Tests durvalumab with chemotherapy before and after surgery in adults with muscle-invasive bladder cancer.
Key facts
- Who runs it
- AstraZeneca
- Where
- Florence, Orbassano, and Rome, ItalySee the 3 sitesAlso in 6 other countries, 55 sites
- Trial code
- Registry title
- Perioperative Durvalumab With Neoadjuvant ddMVAC in Patients With Muscle-Invasive Bladder Cancer (NIAGARA-2)
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 150 people, planned
- Started
- 15 May 2025
- Expected to end
- 30 Aug 2028
- Type of study
- Interventional, 2 groups
- Treatments tested
- Durvalumab
- Methotrexate
- Vinblastine
- Doxorubicin
- Cisplatin
- Gemcitabine
- Record updated
- 8 October 2026
Who can take part
AI summary
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
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Italy
Also in 6 other countries, 55 sites
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, ItalyTaking people
- I.F.O. Istituti Fisioterapici OspitalieriRome, ItalyTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- ddMVAC cohortTreatment being tested
Durvalumab + chemotherapy, approximately 120 participants
Treatment: Durvalumab, Methotrexate, Vinblastine, Doxorubicin, and Cisplatin
- gem/cis cohortTreatment being tested
Durvalumab + chemotherapy; approximately 30 participants; closed to further enrolment
Treatment: Durvalumab, Gemcitabine, and Cisplatin
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- An Open-label, Single-arm, Global Study of Perioperative Durvalumab With Cisplatin-based Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer (NIAGARA-2)
- Plain-language title
- Tests durvalumab with chemotherapy before surgery for bladder cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 8 October 2026