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ACTIVE NOT RECRUITING
NCT03682068
PHASE3

Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).

Official title: A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer.

Key Details

Gender

All

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

1246

Start Date

2018-09-27

Completion Date

2026-04-29

Last Updated

2026-02-03

Healthy Volunteers

No

Interventions

DRUG

Durvalumab

Durvalumab IV (intravenous infusion)

DRUG

Tremelimumab

Tremelimumab IV (intravenous infusion)

DRUG

Cisplatin + Gemcitabine

Cisplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.

DRUG

Carboplatin + Gemcitabine

Carboplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.

Locations (222)

Research Site

Birmingham, Alabama, United States

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Bakersfield, California, United States

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Fullerton, California, United States

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Los Angeles, California, United States

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Salinas, California, United States

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Santa Barbara, California, United States

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Truckee, California, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Orlando, Florida, United States

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Chicago, Illinois, United States

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Fort Wayne, Indiana, United States

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Kansas City, Kansas, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Grand Rapids, Michigan, United States

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Bozeman, Montana, United States

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New Hyde Park, New York, 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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Rochester, New York, United States

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Germantown, Tennessee, United States

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Fort Worth, Texas, United States

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Ciudad de Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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Rosario, Argentina

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Box Hill, Australia

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Elizabeth Vale, Australia

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Kogarah, Australia

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Macquarie University, Australia

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Murdoch, Australia

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Orange, Australia

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South Brisbane, Australia

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St Albans, Australia

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Curitiba, Brazil

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Fortaleza, 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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Ribeirão Preto, Brazil

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Rio de Janeiro, Brazil

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Rio de Janeiro, Brazil

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Salvador, 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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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Hamilton, 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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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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Changsha, China

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Chongqing, China

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Chongqing, China

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Dalian, China

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Guangzhou, China

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Guangzhou, China

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Hangzhou, China

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Hangzhou, China

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Hangzhou, China

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Hangzhou, China

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Jinan, China

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Nanchang, China

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Nanjing, China

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Shanghai, China

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Shanghai, China

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Shenyang, China

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Suzhou, China

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Tianjin, China

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Tianjin, China

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Ürümqi, China

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Wuhan, China

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Xi'an, China

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Brno, Czechia

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Hradec Králové, Czechia

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Olomouc, Czechia

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Ostrava, Czechia

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Prague, Czechia

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Prague, Czechia

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Prague, Czechia

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Budapest, Hungary

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Budapest, Hungary

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Budapest, Hungary

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Debrecen, Hungary

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Győr, Hungary

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Kecskemét, Hungary

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Szolnok, Hungary

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Gūrgaon, India

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Hubli, India

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Kolkata, India

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Mysuru, India

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Nagpur, India

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Nashik, India

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New Delhi, India

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New Delhi, India

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Pune, India

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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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Arezzo, 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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Parma, Italy

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Pavia, Italy

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Roma, Italy

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Terni, Italy

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Verona, Italy

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Bunkyō City, Japan

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Chūōku, Japan

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Fukuoka, Japan

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Hirosaki-shi, Japan

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Kanazawa, Japan

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Kita-gun, Japan

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Koshigaya-shi, Japan

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Kōtoku, Japan

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Kumamoto, Japan

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Kumamoto, Japan

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Kyoto, Japan

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Miyazaki, Japan

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Nagasaki, Japan

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Nagoya, 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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Shinjuku-ku, Japan

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Suita-shi, Japan

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Toyama, Japan

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Yokohama, Japan

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Yokohama, Japan

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Bacolod, Philippines

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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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Poznan, Poland

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Radom, Poland

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Warsaw, Poland

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Ivanovo, Russia

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Krasnoyarsk, Russia

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Moscow, Russia

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Moscow, Russia

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Moscow, Russia

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Moscow, Russia

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Nizhny Novgorod, Russia

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Nizhny Novgorod, Russia

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Omsk, Russia

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Rostov-on-Don, 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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Tyumen, Russia

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Vologda, Russia

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Goyang-si, 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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Seoul, South Korea

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Suwon, South Korea

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Barcelona, Spain

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Barcelona, Spain

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Barcelona, Spain

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Lugo, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Málaga, Spain

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Santander, Spain

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Seville, Spain

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Taichung, 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 District, Taiwan

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Bangkok, Thailand

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Bangkok, Thailand

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Khon Kaen, Thailand

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Mueang, Thailand

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Songkhla, Thailand

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Adana, Turkey (Türkiye)

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Adapazarı, Turkey (Türkiye)

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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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Izmir, Turkey (Türkiye)

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Hanoi, Vietnam

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Hanoi, Vietnam

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Hà Nội, Vietnam

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Ho Chi Minh City, Vietnam