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Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
Sponsor: AstraZeneca
Summary
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.
Official title: A Phase IIIb, Open-label, Single-arm, Global Study of Perioperative Durvalumab With Neoadjuvant ddMVAC or Gem/Cis in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-05-15
Completion Date
2028-10-31
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Durvalumab
Anti- PD-L1 Antibody.
Methotrexate
Chemotherapy agent.
Vinblastine
Chemotherapy agent
Doxorubicin
Chemotherapy agent
Cisplatin
Chemotherapy agent
Durvalumab
Anti- PD-L1 Antibody
Gemcitabine
Chemotherapy agent
Cisplatin
Chemotherapy agent
Locations (59)
Research Site
Chermside, Australia
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Elizabeth Vale, Australia
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Heidelberg, Australia
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Hong Kong, Australia
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Kogarah, Australia
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Macquarie University, Australia
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Murdoch, Australia
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Port Macquarie, Australia
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St Leonards, Australia
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Barretos, Brazil
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Jaú, Brazil
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Natal, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Santo André, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Angers, France
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Angers, France
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Bordeaux, France
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Chambray-lès-Tours, France
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Dijon, France
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Lille, France
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Lyon, France
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Marseille, France
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Montpellier, France
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Nice, France
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Nîmes, France
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Paris, France
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Paris, France
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Pierre-Bénite, France
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Poitiers, France
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Quint-Fonsegrives, France
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Rennes, France
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Rouen, France
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Strasbourg, France
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Suresnes, France
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Florence, Italy
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Orbassano, Italy
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Roma, Italy
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Amsterdam, Netherlands
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Girona, Spain
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Las Palmas de Gran Canaria, Spain
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Lugo, Spain
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Madrid, Spain
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Madrid, Spain
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Santiago de Compostela, Spain