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DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer
Sponsor: AstraZeneca
Summary
DESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.
Official title: DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2025-03-27
Completion Date
2031-02-19
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Trastuzumab deruxtecan
Experimental therapy by intravenous infusion
Rilvegostomig
Experimental therapy by intravenous infusion
Pembrolizumab
Immunotherapy by intravenous infusion
Carboplatin
Standard of Care (SoC) chemotherapy by intravenous infusion
Paclitaxel
Standard of Care (SoC) chemotherapy by intravenous infusion
Docetaxel
Standard of Care (SoC) chemotherapy by intravenous infusion
Locations (249)
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Duarte, California, United States
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Irvine, California, United States
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La Jolla, California, United States
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Palo Alto, California, United States
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San Francisco, California, United States
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Sylmar, California, United States
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Fort Myers, Florida, United States
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Miami Beach, Florida, United States
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Orlando, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Augusta, Georgia, United States
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Honolulu, Hawaii, United States
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Arlington Heights, Illinois, United States
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Evanston, Illinois, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Jackson, Mississippi, United States
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Jackson, Mississippi, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Hackensack, New Jersey, United States
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Albuquerque, New Mexico, 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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New York, New York, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Eugene, Oregon, United States
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Abington, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Austin, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Saint Johnsbury, Vermont, United States
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Charlottesville, Virginia, United States
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Fairfax, Virginia, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Blacktown, Australia
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East Melbourne, Australia
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Nedlands, Australia
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South Brisbane, Australia
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Innsbruck, Austria
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Linz, Austria
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Vienna, Austria
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Wein, Austria
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Anderlecht, Belgium
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Brussels, Belgium
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Charleroi, Belgium
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Ghent, 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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Goiânia, Brazil
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Londrina, 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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Salvador, 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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Teresina, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Beijing, China
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Changchun, China
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Changsha, China
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Chengdu, China
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Chengdu, China
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Chongqing, China
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Fuzhou, China
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Fuzhou, China
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Guangzhou, China
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Guangzhou, China
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Guangzhou, China
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Haikou, China
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Hangzhou, China
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Harbin, China
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Hefei, China
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Jinan, China
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Jinan, China
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Jining, China
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Kunming, China
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Lanzhou, China
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Nanchang, China
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Nanning, China
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Shanghai, China
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Shanghai, China
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Shantou, China
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Shenyang, China
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Shenyang, China
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Taiyuan, China
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Tianjin, China
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Ürümqi, China
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Wuhan, China
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Wuhan, China
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Xi'an, China
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Xuzhou, China
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Yibin, China
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Aalborg, Denmark
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Herlev, Denmark
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København Ø, Denmark
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Odense, Denmark
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Helsinki, Finland
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Oulu, Finland
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Tampere, Finland
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Turku, Finland
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Besançon, France
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Bordeaux, France
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Caen, France
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Clermont-Ferrand, France
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Lyon, France
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Montpellier, France
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Nice, France
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Paris, France
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Plérin, France
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Poitiers, France
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Saint-Herblain, France
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Toulouse, France
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Berlin, Germany
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Chemnitz, Germany
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Dessau, Germany
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Dresden, Germany
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Essen, Germany
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Hamburg, Germany
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Kassel, Germany
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Leipzig, Germany
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Mannheim, Germany
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Marburg, Germany
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Münster, Germany
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Saarbrücken, Germany
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Budapest, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Catania, Italy
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Florence, Italy
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Milan, Italy
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Milan, Italy
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Milan, Italy
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Monza, Italy
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Naples, Italy
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Reggio Emilia, Italy
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Roma, Italy
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Rome, Italy
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Torino, Italy
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Turin, Italy
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Akashi-shi, Japan
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Ginowan-shi, Japan
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Hidaka-shi, Japan
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Isehara-shi, Japan
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Kashiwa, Japan
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Kashiwa-shi, Japan
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Kobe, Japan
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Kōtoku, Japan
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Kurume-shi, Japan
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Matsuyama, Japan
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Morioka, Japan
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Nagoya, Japan
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Niigata, Japan
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Osaka, Japan
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Ota-shi, Japan
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Sapporo, Japan
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Sendai, Japan
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Shinjuku-ku, Japan
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Sunto-gun, Japan
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Tokyo, Japan
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Amsterdam, Netherlands
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Leiden, Netherlands
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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Oslo, Norway
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Stavanger, Norway
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Bialystok, Poland
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Gdansk, Poland
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Lodz, Poland
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Poznan, Poland
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Siedlce, Poland
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Szczecin, Poland
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Goyang-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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Suwon, South Korea
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A Coruña, Spain
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Córdoba, Spain
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Donostia / San Sebastian, Spain
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El Palmar, Spain
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L'Hospitalet de Llobregat, Spain
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Madrid, Spain
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Madrid, Spain
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Palma de Mallorca, Spain
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Valencia, Spain
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Valencia, Spain
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Zaragoza, Spain
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Linköping, Sweden
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Lund, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Frauenfeld, Switzerland
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Liestal, Switzerland
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Sankt Gallen, Switzerland
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Zurich, Switzerland
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Changhua, Taiwan
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Kaohsiung City, Taiwan
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New Taipei City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Bath, United Kingdom
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Cambridge, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Northwood, United Kingdom
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Taunton, United Kingdom