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Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer
Sponsor: AstraZeneca
Summary
A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer
Official title: A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Cancer
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
1126
Start Date
2015-11-02
Completion Date
2026-12-31
Last Updated
2026-01-28
Healthy Volunteers
No
Conditions
Interventions
MEDI4736 (Durvalumab)
IV infusion
Tremelimumab
IV infusion
Cisplatin
IV infusion
Carboplatin
IV infusion
Gemcitabine
IV infusion
Locations (222)
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Los Angeles, California, United States
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Stanford, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Louisville, Kentucky, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Omaha, Nebraska, United States
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New York, New York, United States
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New York, New York, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Seattle, Washington, United States
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Box Hill, Australia
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Elizabeth Vale, Australia
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Macquarie University, Australia
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St Leonards, Australia
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Waratah, Australia
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Linz, Austria
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Vienna, Austria
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Vienna, Austria
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Brussels, Belgium
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Brussels, Belgium
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Leuven, Belgium
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Liège, Belgium
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Barretos, Brazil
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Belo Horizonte, Brazil
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Ijuí, Brazil
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Itajaí, 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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Rio de Janeiro, 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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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Hamilton, Ontario, Canada
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Newmarket, Ontario, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Beijing, China
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Beijing, China
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Beijing, China
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Changchun, China
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Changsha, China
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Chongqing, China
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Hangzhou, China
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Hangzhou, China
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Nanjing, China
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Shanghai, China
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Shanghai, China
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Shanghai, China
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Shanghai, China
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Shanghai, China
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Shenyang, China
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Tianjin, China
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Xi'an, China
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Xiamen, China
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Århus C, Denmark
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Herlev, Denmark
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København Ø, Denmark
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Odense C, Denmark
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Bordeaux, France
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Bordeaux, France
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Caen, France
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Lyon, France
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Marseille, France
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Paris, France
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Poitiers, France
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Suresnes, France
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Toulouse, France
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Villejuif, France
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Düsseldorf, Germany
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Erlangen, Germany
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Hanover, Germany
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Heidelberg, Germany
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Jena, Germany
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München, Germany
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Münster, Germany
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Athens, Greece
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Athens, Greece
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Heraklion, Greece
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Holargos, Athens, Greece
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Maroussi, Athens, Greece
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Pátrai, Greece
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Thessaloniki, Greece
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Haifa, Israel
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Jerusalem, Israel
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Petah Tikva, Israel
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Ramat Gan, Israel
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Ẕerifin, Israel
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Arezzo, Italy
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Meldola, Italy
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Milan, Italy
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Milan, Italy
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Naples, Italy
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Orbassano, Italy
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Pavia, Italy
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Roma, Italy
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San Giovanni Rotondo, Italy
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Akita, Japan
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Bunkyō City, Japan
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Fukuoka, Japan
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Hakata-shi, Japan
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Hirosaki-shi, Japan
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Hiroshima, Japan
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Izumo-shi, Japan
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Kagoshima, Japan
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Kanazawa, Japan
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Kita-gun, Japan
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Kobe, Japan
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Koshigaya-shi, Japan
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Kōtoku, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Matsuyama, Japan
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Morioka, Japan
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Nagasaki, Japan
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Nagoya, Japan
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Nagoya, Japan
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Osaka, Japan
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Osaka, Japan
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Osakasayama-shi, Japan
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Saga, Japan
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Sagamihara-shi, Japan
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Sakura-shi, Japan
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Sapporo, Japan
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Suita-shi, Japan
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Takatsuki-shi, Japan
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Yokohama, Japan
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Yokohama, Japan
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Guadalajara, Mexico
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León, Mexico
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Mexico City, Mexico
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México, Mexico
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México, Mexico
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Monterrey, Mexico
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Amsterdam, Netherlands
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Amsterdam, Netherlands
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Breda, Netherlands
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Enschede, Netherlands
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Groningen, Netherlands
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Leiden, Netherlands
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Maastricht, Netherlands
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Nijmegen, Netherlands
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Gdansk, Poland
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Gdansk, Poland
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Gdynia, Poland
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Gliwice, Poland
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Olsztyn, Poland
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Otwock, Poland
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Szczecin, Poland
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Warsaw, Poland
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Lisbon, Portugal
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Loures, Portugal
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Porto, Portugal
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Moscow, Russia
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Moscow, Russia
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Murmansk, Russia
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Nizhnyi Novgorod, Russia
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Obninsk, Russia
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Omsk, 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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Saint Petersburg, Russia
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Ufa, Russia
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Yaroslavl, Russia
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Incheon, South Korea
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Seongnam-si, 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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Seoul, South Korea
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Seoul, South Korea
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Badajoz, Spain
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Badalona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Elche(Alicante), Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Pozuelo de Alarcón, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Kaohsiung City, Taiwan
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Taichung, 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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Izmir, Turkey (Türkiye)
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Cambridge, United Kingdom
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Cardiff, United Kingdom
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Glasgow, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Metropolitan Borough of Wirral, United Kingdom
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Sheffield, United Kingdom
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Southampton, United Kingdom