Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
NCT ID: NCT06960577
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2025-05-15
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ddMVAC cohort
Durvalumab + chemotherapy
Durvalumab
Anti- PD-L1 Antibody.
Methotrexate
Chemotherapy agent.
Vinblastine
Chemotherapy agent
Doxorubicin
Chemotherapy agent
Cisplatin
Chemotherapy agent
gem/cis cohort
Durvalumab + chemotherapy
Durvalumab
Anti- PD-L1 Antibody
Gemcitabine
Chemotherapy agent
Cisplatin
Chemotherapy agent
Interventions
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Durvalumab
Anti- PD-L1 Antibody
Gemcitabine
Chemotherapy agent
Cisplatin
Chemotherapy agent
Durvalumab
Anti- PD-L1 Antibody.
Methotrexate
Chemotherapy agent.
Vinblastine
Chemotherapy agent
Doxorubicin
Chemotherapy agent
Cisplatin
Chemotherapy agent
Eligibility Criteria
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Inclusion Criteria
* Patients must be planning to undergo radical cystectomy
* Patients 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 Criteria
* Inoperable tumour(s) with fixation to the pelvic wall on clinical examination
* 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 to the chemotherapy (ddMVAC or gem/cis).
* Uncontrolled intercurrent illness.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Chermside, , Australia
Research Site
Elizabeth Vale, , Australia
Research Site
Heidelberg, , Australia
Research Site
Hong Kong, , Australia
Research Site
Kogarah, , Australia
Research Site
Macquarie University, , Australia
Research Site
Murdoch, , Australia
Research Site
Port Macquarie, , Australia
Research Site
St Leonards, , Australia
Research Site
Barretos, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
Santo André, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Hamilton, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Québec, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
Research Site
Angers, , France
Research Site
Angers, , France
Research Site
Bordeaux, , France
Research Site
Chambray-lès-Tours, , France
Research Site
Dijon, , France
Research Site
Lille, , France
Research Site
Lyon, , France
Research Site
Marseille, , France
Research Site
Montpellier, , France
Research Site
Nice, , France
Research Site
Nîmes, , France
Research Site
Paris, , France
Research Site
Paris, , France
Research Site
Pierre-Bénite, , France
Research Site
Poitiers, , France
Research Site
Quint-Fonsegrives, , France
Research Site
Rennes, , France
Research Site
Rouen, , France
Research Site
Strasbourg, , France
Research Site
Suresnes, , France
Research Site
Florence, , Italy
Research Site
Orbassano, , Italy
Research Site
Roma, , Italy
Research Site
Amsterdam, , Netherlands
Research Site
Nijmegen, , Netherlands
Research Site
Rotterdam, , Netherlands
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Girona, , Spain
Research Site
Las Palmas de Gran Canaria, , Spain
Research Site
Lugo, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Santiago de Compostela, , Spain
Countries
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Central Contacts
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Other Identifiers
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D933RC00002
Identifier Type: -
Identifier Source: org_study_id