NCT06960577RecruitingPhase 2
Perioperative Durvalumab With Neoadjuvant ddMVAC in Patients With Muscle-Invasive Bladder Cancer (NIAGARA-2)
An Open-label, Single-arm, Global Study of Perioperative Durvalumab With Cisplatin-based Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer (NIAGARA-2)
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 29 Apr 2025
- Start date
- 15 May 2025
- Primary completion date
- 30 Aug 2028
- Lead sponsor
- AstraZeneca
- Diseases
- Bladder cancer
- NCT number
- NCT06960577
- EU CT number
- 2024-519246-75-01
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- From 15 May 2025 to the primary completion date, 30 Aug 2028
- 58 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Evidence of lymph node (N2-N3) or metastatic (M1) disease
- Uncontrolled intercurrent illness.
Other
- Inoperable tumour(s) with fixation to the pelvic wall on clinical examination
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (58)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Chermside | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Elizabeth Vale | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Hong Kong | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Kogarah | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Macquarie University | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Murdoch | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Port Macquarie | Australia | Withdrawn |
| - Coordinator of this site? Confirm its status | St Leonards | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Barretos | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Jaú | Brazil | Withdrawn |
| - Coordinator of this site? Confirm its status | Natal | Brazil | Withdrawn |
| - Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Withdrawn |
| - Coordinator of this site? Confirm its status | Santo André | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Withdrawn |
| - Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Ottawa | Canada | Withdrawn |
| - Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Sherbrooke | Canada | Recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Vall d'Hebron Institute of Oncology Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Institut Català d'Oncologia Coordinator of this site? Confirm its status | Girona | Spain | Recruiting |
| Complejo Hospitalario Universitario Insular Materno Infantil Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Recruiting |
| Hospital Universitario Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Institut de Cancerologie de L'Ouest Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Hospitalier Universitaire De Bordeaux Coordinator of this site? Confirm its status | Bordeaux Cedex | France | Recruiting |
| Centre D'Oncologie Et de Radiotherapie 37 Coordinator of this site? Confirm its status | Chambray-lès-Tours | France | Recruiting |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre De Cancerologue Du Grand Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice Cedex 2 | France | Recruiting |
| Institut de Cancérologie du Gard Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
| Hopital Européen George Pompidou Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Capio La Croix Du Sud Coordinator of this site? Confirm its status | Quint-Fonsegrives | France | Recruiting |
| Centre De Lutte Contre Le Cancer Eugene Marquis Coordinator of this site? Confirm its status | Rennes Cedex | France | Recruiting |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Recruiting |
| Hospital Foch Coordinator of this site? Confirm its status | Suresnes | France | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Netherlands Cancer Institute Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.