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ACTIVE NOT RECRUITING
NCT03737643
PHASE3

Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.

Official title: A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).

Key Details

Gender

FEMALE

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

1407

Start Date

2019-01-04

Completion Date

2028-03-30

Last Updated

2025-01-29

Healthy Volunteers

No

Interventions

DRUG

Bevacizumab

Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice.

DRUG

Durvalumab

Durvalumab by intravenous infusion

DRUG

Olaparib

Olaparib tablets

DRUG

Placebo olaparib

Placebo tablets to match olaparib

DRUG

Durvalumab placebo

Matching placebo for intravenous infusion

DRUG

Carboplatin+Paclitaxel

Standard of care chemotherapy

Locations (214)

Research Site

Foothill Ranch, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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San Francisco, California, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Hinsdale, Illinois, United States

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Indianapolis, Indiana, United States

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Towson, Maryland, United States

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Detroit, Michigan, United States

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Springfield, Missouri, United States

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Middletown, New Jersey, United States

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Montvale, New Jersey, United States

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Albany, New York, United States

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New York, New York, United States

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Uniondale, New York, United States

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Durham, North Carolina, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Hilliard, Ohio, United States

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Tulsa, Oklahoma, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Salt Lake City, Utah, United States

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Graz, Austria

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Innsbruck, Austria

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Linz, Austria

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Vienna, Austria

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Aalst, Belgium

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Leuven, Belgium

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Namur, Belgium

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Ostend, Belgium

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Sint-Niklaas, Belgium

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Barretos, Brazil

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Florianópolis, Brazil

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Fortaleza, 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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São Paulo, Brazil

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São Paulo, Brazil

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Burgas, Bulgaria

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Plovdiv, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Calgary, Alberta, Canada

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Barrie, Ontario, Canada

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Greater Sudbury, 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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Rimouski, Quebec, Canada

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Beijing, China

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Beijing, China

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Bengbu, China

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Changchun, China

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Changsha, China

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Changsha, China

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Chengdu, 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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Harbin, China

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Hefei, China

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Jinhua, China

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Kunming, China

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Lanzhou, China

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Luzhou, China

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Nanchong, China

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Nanjing, China

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Nanning, China

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Nantong, China

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Shanghai, China

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Shanghai, China

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Wuhan, China

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Wuhan, China

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Xi'an, China

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Zhengzhou, China

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Zhengzhou, China

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Zhuhai, China

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Aalborg, Denmark

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Aarhus N, Denmark

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Odense, Denmark

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Roskilde, Denmark

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Vejle, Denmark

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Kuopio, Finland

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Oulu, Finland

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Turku, Finland

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Besançon, France

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Bordeaux, France

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Limoges, France

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Lyon, France

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Marseille, France

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Nantes, France

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Paris, France

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Paris, France

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Paris, France

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Saint-Herblain, France

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Vandœuvre-lès-Nancy, France

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Bad Homburg, Germany

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Berlin, Germany

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Bielefeld, Germany

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Bonn, Germany

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Brandenburg, Germany

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Cologne, Germany

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Dresden, Germany

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Düsseldorf, Germany

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Essen, Germany

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Essen, Germany

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Esslingen am Neckar, Germany

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Frankfurt, Germany

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Freiburg im Breisgau, Germany

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Fürth, Germany

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Greifswald, Germany

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Gütersloh, Germany

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Hamburg, Germany

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Hamburg, Germany

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Hamburg, Germany

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Hanover, Germany

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Hanover, Germany

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Jena, Germany

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Karlsruhe, Germany

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Karlsruhe, Germany

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Kassel, Germany

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Kiel, Germany

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Leipzig, Germany

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Ludwigsburg, Germany

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Lübeck, Germany

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Mainz, Germany

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Mannheim, Germany

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München, Germany

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Offenbach, Germany

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Oldenburg, Germany

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Rosenheim, Germany

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Rostock, Germany

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Saalfeld, Germany

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Schweinfurt, Germany

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Tübingen, Germany

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Ulm, Germany

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Worms, Germany

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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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Kaposvár, Hungary

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Szeged, Hungary

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Zalaegerszeg, Hungary

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Brescia, Italy

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Lecce, Italy

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Lecco, Italy

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Milan, Italy

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Milan, Italy

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Mirano, Italy

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Naples, Italy

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Reggio Calabria, Italy

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Reggio Emilia, Italy

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Roma, Italy

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Torino, Italy

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Torino, Italy

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Fukuoka, 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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Kyoto, Japan

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Minatoku, Japan

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Nagoya, Japan

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Niigata, Japan

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Okayama, 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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Toyoake-shi, Japan

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Bellavista, Peru

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La Libertad, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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San Isidro, Peru

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Gdynia, Poland

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Lodz, Poland

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Szczecin, Poland

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Warsaw, Poland

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Warsaw, Poland

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Floreşti, Romania

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Goyang-si, 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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Suwon, South Korea

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Córdoba, 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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Terrassa(Barcelona), Spain

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Vigo, Spain

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Adana, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)