Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
NCT ID: NCT03732677
Last Updated: 2025-11-21
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1063 participants
INTERVENTIONAL
2018-11-16
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Chemotherapy + Durvalumab
Durvalumab
Anti- PD-L1 Antibody
Cisplatin
Chemotherapy Agent
Gemcitabine
Chemotherapy agent
Arm 2
Chemotherapy alone
Cisplatin
Chemotherapy Agent
Gemcitabine
Chemotherapy agent
Interventions
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Durvalumab
Anti- PD-L1 Antibody
Cisplatin
Chemotherapy Agent
Gemcitabine
Chemotherapy agent
Eligibility Criteria
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Inclusion Criteria
* Patients must be planning to undergo a radical cystectomy
* Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC
* ECOG performance status of 0 or 1
* Must have a life expectancy of at least 12 weeks at randomization
Exclusion:
* Evidence of lymph node (N2-N3) or metastatic (M1) disease at time of screening.
* Prior pelvic radiotherapy treatment within 2 years of randomization to study
* Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin \[BCG\]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies.
* Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product (IP). The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent; Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
* Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
* Uncontrolled intercurrent illness
* Active infection including Tuberculosis, Hepatitis B, Hepatitis C, and Human Immunodeficiency
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
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Los Angeles, California, United States
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Palo Alto, California, United States
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New Haven, Connecticut, United States
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Chicago, Illinois, United States
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Geneva, Illinois, United States
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Iowa City, Iowa, United States
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Westwood, Kansas, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Towson, Maryland, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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New York, New York, United States
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Rochester, New York, United States
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Bethlehem, Pennsylvania, United States
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Burlington, Vermont, United States
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Milwaukee, Wisconsin, United States
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Brisbane, , Australia
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Elizabeth Vale, , Australia
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Macquarie University, , Australia
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Melbourne, , Australia
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Murdoch, , Australia
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South Brisbane, , Australia
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Bruges, , Belgium
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Charleroi, , Belgium
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Kortrijk, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Roeselare, , Belgium
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Barretos, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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Santa Maria, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Antofagasta, , Chile
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Port Montt, , Chile
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Santiago, , Chile
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Temuco, , Chile
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Temuco, , Chile
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Viña del Mar, , Chile
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Brno, , Czechia
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Brno, , Czechia
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Hradec Králové, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Angers, , France
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Dijon, , France
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Grenoble, , France
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Montpellier, , France
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Nîmes, , France
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Pierre-Bénite, , France
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Poitiers, , France
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Rouen, , France
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Bergisch Gladbach, , Germany
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Bonn, , Germany
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Cologne, , Germany
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Erlangen, , Germany
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Göttingen, , Germany
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Herne, , Germany
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Jena, , Germany
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Magdeburg, , Germany
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Mannheim, , Germany
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Münster, , Germany
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Nuremberg, , Germany
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Oldenburg, , Germany
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Regensburg, , Germany
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Ulm, , Germany
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Würzburg, , Germany
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Haifa, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Bari, , Italy
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Bologna, , Italy
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Florence, , Italy
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Milan, , Italy
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Milan, , Italy
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Napoli, , Italy
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Orbassano, , Italy
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Pozzuoli, , Italy
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Verona, , Italy
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Bunkyō City, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Hirosaki-shi, , Japan
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Hiroshima, , Japan
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Kanazawa, , Japan
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Kōtoku, , Japan
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Kumamoto, , Japan
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Miyazaki, , Japan
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Nagasaki, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Sendai, , Japan
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Toyama, , Japan
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Tsukuba, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Breda, , Netherlands
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Rotterdam, , Netherlands
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Baguio City, , Philippines
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Cebu, , Philippines
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Davao City, , Philippines
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Makati, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Bialystok, , Poland
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Gdansk, , Poland
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Grudziądz, , Poland
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Koszalin, , Poland
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Krakow, , Poland
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Olsztyn, , Poland
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Ostrołęka, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Ufa, , Russia
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Vologda, , Russia
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Daegu, , South Korea
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Goyang-si, , South Korea
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Gyeonggi-do, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Badalona, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Las Palmas de Gran Canaria, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Santander, , Spain
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Seville, , Spain
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan, , Taiwan
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Ankara, , Turkey (Türkiye)
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Edirne, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Karşıyaka, , Turkey (Türkiye)
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Edinburgh, , United Kingdom
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London, , United Kingdom
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Metropolitan Borough of Wirral, , United Kingdom
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Nottingham, , United Kingdom
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Sheffield, , United Kingdom
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Hochiminh, , Vietnam
Countries
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References
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Powles T, Catto JWF, Galsky MD, Al-Ahmadie H, Meeks JJ, Nishiyama H, Vu TQ, Antonuzzo L, Wiechno P, Atduev V, Kann AG, Kim TH, Suarez C, Chang CH, Roghmann F, Ozguroglu M, Eigl BJ, Oliveira N, Buchler T, Gadot M, Zakharia Y, Armstrong J, Gupta A, Hois S, van der Heijden MS; NIAGARA Investigators. Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer. N Engl J Med. 2024 Nov 14;391(19):1773-1786. doi: 10.1056/NEJMoa2408154. Epub 2024 Sep 15.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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D933RC00001\_CSR synopsis\_Redacted
Other Identifiers
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2023-510015-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-001811-59
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D933RC00001
Identifier Type: -
Identifier Source: org_study_id
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