Bladder Cancer Clinical Trial

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

Summary

A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

View Eligibility Criteria

Eligibility Criteria

Inclusion:

Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology
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

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

1063

Study ID:

NCT03732677

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 185 Locations for this study

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Birmingham Alabama, 35294, United States
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Los Angeles California, 90095, United States
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Palo Alto California, 94304, United States
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New Haven Connecticut, 06520, United States
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Chicago Illinois, 60611, United States
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Geneva Illinois, 60134, United States
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Iowa City Iowa, 52242, United States
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Westwood Kansas, 66205, United States
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Louisville Kentucky, 40202, United States
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New Orleans Louisiana, 70112, United States
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Towson Maryland, 21204, United States
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Ann Arbor Michigan, 48109, United States
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Detroit Michigan, 48201, United States
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New York New York, 10029, United States
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Rochester New York, 14642, United States
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Bethlehem Pennsylvania, 18015, United States
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Burlington Vermont, 05401, United States
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Milwaukee Wisconsin, 53226, United States
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Brisbane , 4122, Australia
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Elizabeth Vale , 5112, Australia
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Macquarie University , 2109, Australia
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Melbourne , 3004, Australia
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Murdoch , 6150, Australia
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South Brisbane , 4101, Australia
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Brugge , 8000, Belgium
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Charleroi , 6000, Belgium
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Kortrijk , 8500, Belgium
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Leuven , 3000, Belgium
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Liège , 4000, Belgium
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Roeselare , 8800, Belgium
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Barretos , 14784, Brazil
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Porto Alegre , 90020, Brazil
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Porto Alegre , 90470, Brazil
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Porto Alegre , 90610, Brazil
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Porto Alegre , 91350, Brazil
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Rio de Janeiro , 20231, Brazil
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Santa Maria , 97015, Brazil
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Sao Paulo , 01323, Brazil
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Sao Paulo , 01509, Brazil
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São José do Rio Preto , 15090, Brazil
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São Paulo , 01246, Brazil
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São Paulo , 03102, Brazil
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Edmonton Alberta, T6G 1, Canada
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Vancouver British Columbia, V5Z 4, Canada
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London Ontario, N6A 5, Canada
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Ottawa Ontario, K1H 8, Canada
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Toronto Ontario, M5G I, Canada
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Montreal Quebec, H2X 0, Canada
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Sherbrooke Quebec, J1H 5, Canada
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Antofagasta , 12673, Chile
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Puerto Montt , 54800, Chile
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Santiago , 75203, Chile
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Temuco , 48102, Chile
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Temuco , 48104, Chile
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Viña del Mar , 25404, Chile
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Brno , 656 5, Czechia
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Brno , 656 9, Czechia
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Hradec Kralove , 500 0, Czechia
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Olomouc , 779 0, Czechia
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Praha 2 , 128 0, Czechia
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Praha 8 , 180 8, Czechia
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Praha , 140 5, Czechia
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Angers Cedex 01 , 49033, France
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Dijon , 21079, France
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Grenoble Cedex 09 , 38043, France
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Montpellier , 34070, France
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Nimes , 30029, France
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Pierre Benite , 69495, France
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Poitiers Cedex , 86021, France
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Rouen , F-760, France
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Bergisch Gladbach , 51465, Germany
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Bonn , 53127, Germany
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Erlangen , 91054, Germany
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Göttingen , 37075, Germany
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Herne , 44625, Germany
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Jena , 07747, Germany
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Köln , 50937, Germany
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Magdeburg , 39120, Germany
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Mannheim , 68167, Germany
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Münster , 48149, Germany
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Nürnberg , 90491, Germany
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Oldenburg , 23758, Germany
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Regensburg , 93053, Germany
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Ulm , 89081, Germany
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Würzburg , 97080, Germany
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Haifa , 31096, Israel
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Jerusalem , 91120, Israel
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Kfar Saba , 95847, Israel
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Petach-Tikva , 49414, Israel
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Ramat Gan , 52621, Israel
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Bari , 70124, Italy
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Bologna , 40138, Italy
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Firenze , 50134, Italy
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Milano , 20132, Italy
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Milano , 20133, Italy
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Napoli , 80131, Italy
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Orbassano , 10043, Italy
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Pozzuoli , 80078, Italy
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Verona , 37126, Italy
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Bunkyo-ku , 113-8, Japan
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Fukuoka-shi , 811-1, Japan
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Fukuoka , 812-8, Japan
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Hirosaki-shi , 036-8, Japan
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Hiroshima-shi , 730-8, Japan
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Kanazawa-shi , 920-8, Japan
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Koto-ku , 135-8, Japan
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Kumamoto-shi , 860-0, Japan
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Miyazaki-city , 889-1, Japan
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Nagasaki-shi , 852-8, Japan
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Nagoya-shi , 466-8, Japan
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Niigata-shi , 951-8, Japan
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Osaka-shi , 541-8, Japan
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Osaka-shi , 545-8, Japan
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Osakasayama-shi , 589-8, Japan
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Sendai-shi , 980-0, Japan
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Shinjuku-ku , 160-8, Japan
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Toyama-shi , 930-0, Japan
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Tsukuba-shi , 305-8, Japan
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Yokohama-shi , 232-0, Japan
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Yokohama-shi , 241-8, Japan
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Daegu , 41404, Korea, Republic of
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Goyang-si , 10408, Korea, Republic of
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Gyeonggi-do , 13620, Korea, Republic of
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Incheon , 21565, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 136-7, Korea, Republic of
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Amsterdam , 1066 , Netherlands
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Amsterdam , 1081 , Netherlands
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Breda , 4818 , Netherlands
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Rotterdam , 3015 , Netherlands
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Baguio City , 2600, Philippines
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Cebu , 6000, Philippines
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Davao City , 8000, Philippines
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Makati , 1229, Philippines
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Manila , 1015, Philippines
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Quezon City , 1101, Philippines
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Quezon City , 1104, Philippines
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Bialystok , 15-02, Poland
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Gdańsk , 80-21, Poland
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Grudziądz , 86-30, Poland
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Koszalin , 75-58, Poland
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Kraków , 30-51, Poland
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Olsztyn , 10-22, Poland
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Ostrołęka , 07-41, Poland
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Poznan , 60-69, Poland
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Warszawa , 02-78, Poland
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Wroclaw , 53-41, Poland
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Krasnoyarsk , 66013, Russian Federation
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Moscow , 10507, Russian Federation
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Nizhniy Novgorod , 60307, Russian Federation
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Novosibirsk , 63000, Russian Federation
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Samara , 44303, Russian Federation
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St Petersburg , 19404, Russian Federation
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St. Petersburg , 19401, Russian Federation
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St. Petersburg , 19435, Russian Federation
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St. Petersburg , 19702, Russian Federation
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Ufa , 45000, Russian Federation
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Vologda , 16001, Russian Federation
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Badalona , 08916, Spain
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Barcelona , 08035, Spain
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Córdoba , 14004, Spain
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Las Palmas de Gran Canaria , 35016, Spain
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Madrid , 28007, Spain
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Madrid , 28041, Spain
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Santander , 39008, Spain
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Sevilla , 41013, Spain
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Kaohsiung , 807, Taiwan
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Taichung , 404, Taiwan
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Taichung , 40705, Taiwan
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Tainan , 704, Taiwan
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Tainan , 710, Taiwan
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Taipei City , 10050, Taiwan
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Taipei , 11217, Taiwan
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Taoyuan City , 333, Taiwan
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Ankara , 06590, Turkey
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Edirne , 22030, Turkey
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Istanbul , 34030, Turkey
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İstanbul , 34457, Turkey
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Izmir , , Turkey
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Karsiyaka , 35575, Turkey
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Edinburgh , EH4 2, United Kingdom
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London , E1 1B, United Kingdom
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Nottingham , NG5 1, United Kingdom
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Sheffield , S10 2, United Kingdom
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Wirral , CH63 , United Kingdom
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Hanoi , 10000, Vietnam
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Ho Chi Minh , 70000, Vietnam
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Hochiminh , 70000, Vietnam

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

1063

Study ID:

NCT03732677

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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