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NCT06079671PHASE3Recruiting

Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)

AstraZeneca

Start Date

9/22/2023

Completion Date

9/30/2030

Summary

This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.

Detailed Description

Women with locally advanced cervical cancer will be randomized in a 1:1 ratio to receive treatment with Volrustomig or Placebo.

Eligibility Criteria

Age Range: 15 years to No maximum

Inclusion Criteria: For inclusion in the study, patients should fulfill the following criteria: 1. Female. 2. Aged at least 15 years at the time of screening. Note: Participants \< 18 years of age: physical changes should be aligned with Tanner Stage III. 3. Body weight \> 35 kg. 4. Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease. 5. Initial staging procedures performed no more than 56 days prior to the first dose of CCRT. 6. Provision of FFPE tumor sample to assess the PD-L1 expression. 7. Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent. 8. WHO/ECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks. 9. Adequate organ and bone marrow function. 10. Capable of providing signed informed consent. Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer. 2. Evidence of metastatic disease. 3. Intent to administer a fertility-sparing treatment regimen. 4. History of organ transplant or allogenic stem cell transplant. 5. History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders. 6. Uncontrolled intercurrent illness. 7. History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease. 8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated. 9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula. 10. History of anaphylaxis to any biologic therapy or vaccine. 11. Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg/day of prednisone (or equivalent) in the preceding 14 days. 12. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy. 13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer. 14. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery. 15. Exposure to immune mediated therapy prior to the study for any indication. 16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention. 17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.

Interventions

BIOLOGICAL

Volrustomig

OTHER

Placebo

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Conditions

Locally Advanced Cervical Cancer

Locations

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Birmingham, Alabama 35233

United States

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Phoenix, Arizona 85016

United States

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Tucson, Arizona 85711

United States

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Little Rock, Arkansas 72205

United States

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La Jolla, California 92093

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West Hollywood, California 90048

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Atlanta, Georgia 30322

United States

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Augusta, Georgia 30912

United States

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Savannah, Georgia 31405

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Melrose Park, Illinois 60160

United States

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Indianapolis, Indiana 46202

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New Orleans, Louisiana 70112

United States

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New Orleans, Louisiana 70121

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Shreveport, Louisiana 71103

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New York, New York 10016

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Syracuse, New York 13210

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Cleveland, Ohio 44195

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Columbus, Ohio 43210

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Eugene, Oregon 97401

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Philadelphia, Pennsylvania 19107

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Providence, Rhode Island 02905

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Dallas, Texas 75390

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Fort Worth, Texas 76104

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Houston, Texas 77030

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Tyler, Texas 75702

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Charlottesville, Virginia 22908

United States

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Fairfax, Virginia 22031

United States

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Richmond, Virginia 23298

United States

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Barretos, 14784-400

Brazil

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Belo Horizonte, 30130-100

Brazil

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Curitiba, 80730-150

Brazil

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Fortaleza, 60336-045

Brazil

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Fortaleza, 60430-230

Brazil

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Goiânia, 74110-060

Brazil

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Ijuí, 98700-000

Brazil

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Natal, 59075-740

Brazil

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Porto Alegre, 90570-060

Brazil

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Porto Alegre, 90619-900

Brazil

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Porto Alegre, 98850-170

Brazil

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Porto Velho, 76834-899

Brazil

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Recife, 52010-075

Brazil

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Rio de Janeiro, 20220-410

Brazil

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Salvador, 40050 410

Brazil

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São Paulo, 01246-000

Brazil

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São Paulo, 01323-000

Brazil

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São Paulo, 1323001

Brazil

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Teresina, 64049-200

Brazil

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Hamilton, Ontario L8V 1C3

Canada

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London, Ontario N6A 5W9

Canada

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Toronto, Ontario M4N 3M5

Canada

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Toronto, Ontario M5G 2M9

Canada

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Montreal, Quebec H2X 0C1

Canada

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Montreal, Quebec H3G 1A4

Canada

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Ste-Foy, Quebec G1V 4G2

Canada

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Beijing, 100026

China

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Beijing, 100142

China

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Beijing, 100730

China

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Changde, 415000

China

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Changsha, 410008

China

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Changsha, 410013

China

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Chengdu, 610041

China

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Chengdu, 610044

China

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Chongqing, 400030

China

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Fuzhou, 350014

China

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Ganzhou, 341000

China

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Guangzhou, 510060

China

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Guangzhou, 510120

China

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Hangzhou, 310022

China

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Harbin, 150081

China

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Kunming, 650118

China

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Lanzhou, 730000

China

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Lanzhou, 730050

China

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Linyi, 276001

China

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Luzhou, 646000

China

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Nanchang, 330006

China

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Nanchang, 330029

China

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Shandong,

China

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Shanghai, 200032

China

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Shanghai, 200080

China

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Shenyang, 110004

China

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Shenzhen, 518036

China

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Shenzhen, 518116

China

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Tianjin, 300060

China

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Wuhan, 430022

China

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Wuhan, 430030

China

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Xi'an, 710061

China

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Yibin, 610500

China

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Yinchuan, 750004

China

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Zhengzhou, 450008

China

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Zhengzhou, 450052

China

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Zhuzhou, 412007

China

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Aarhus N, 8200

Denmark

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København Ø, 2100

Denmark

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Odense, 5000

Denmark

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Berlin, 13353

Germany

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Bonn, 53127

Germany

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Hamburg, 20246

Germany

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Leipzig, 04103

Germany

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Calicut, 673601

India

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Jaipur, 302017

India

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Lucknow, 226003

India

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Madurai, 625107

India

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Mohali, 160055

India

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Nagpur, 440001

India

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Nashik, 422009

India

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Nashik, 422011

India

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New Delhi, 11029

India

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Vadodara, 391760

India

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Bari, 70124

Italy

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Bologna, 40138

Italy

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Catania, 95126

Italy

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Florence, 50141

Italy

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Lecco, 23900

Italy

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Milan, 20133

Italy

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Milan, 20141

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Milan, 20159

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Monza, 20900

Italy

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Naples, 80131

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Roma, 161

Italy

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Rome, 00168

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Turin, 10128

Italy

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Fukuoka, 812-8582

Japan

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Ginowan-shi, 901-2725

Japan

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Hidaka-shi, 350-1298

Japan

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Kagoshima, 890-8520

Japan

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Kōtoku, 135-8550

Japan

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Kurume-shi, 830-0011

Japan

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Maebashi, 371-8511

Japan

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Matsuyama, 791-0280

Japan

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Morioka, 028-3695

Japan

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Nagoya, 464-8681

Japan

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Osaka, 541-8567

Japan

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Sapporo, 003-0804

Japan

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Sapporo, 060-8638

Japan

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Shinjuku-ku, 160-8582

Japan

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Suita-shi, 565-0871

Japan

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Sunto-gun, 411-8777

Japan

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Toon-Shi, 791-0295

Japan

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Coyoacán, 04380

Mexico

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Culiacán, 80040

Mexico

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Guadalajara, 44650

Mexico

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Guadalajra, 44260

Mexico

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Mexico City, 03240

Mexico

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México, 04700

Mexico

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México, 14080

Mexico

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Monterrey, 64460

Mexico

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Oslo, 424

Norway

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Trondheim, 7030

Norway

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Concepción, 12125

Peru

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Lima, 15036

Peru

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Lima, 15038

Peru

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Lima, 15102

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Lima, LIMA 29

Peru

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Lima, Lima 34

Peru

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Lima, Lima39

Peru

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Bialystok, 15-027

Poland

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Gdansk, 80-214

Poland

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Gliwice, 44-101

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Krakow, 30-348

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Lodz, 90-513

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Poznan, 61-866

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Warsaw, 02-781

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Wroclaw, 53-413

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San Juan, 00927

Puerto Rico

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Daegu, 42601

South Korea

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Goyang-si, 10408

South Korea

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Gyeonggi-do, 13605

South Korea

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Seoul, 03080

South Korea

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Seoul, 03722

South Korea

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Seoul, 06351

South Korea

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Seoul, 5505

South Korea

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A Coruña, 15009

Spain

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Barcelona, 08036

Spain

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Barcelona, 8035

Spain

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Córdoba, 14004

Spain

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Girona, 17007

Spain

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Hospitalet deLlobregat, 08907

Spain

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Madrid, 28034

Spain

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Madrid, 28040

Spain

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Madrid, 28041

Spain

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Madrid, 28046

Spain

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Palma de Mallorca, 07010

Spain

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Valencia, 46009

Spain

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Valencia, 46010

Spain

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Changhua, 50006

Taiwan

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Kaohsiung City, 81362

Taiwan

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Kaohsiung City, 833

Taiwan

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New Taipei City, 220

Taiwan

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Taichung, 40447

Taiwan

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Taichung, 40705

Taiwan

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Tainan, 704

Taiwan

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Taipei, 10449

Taiwan

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Taipei, 11217

Taiwan

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Taoyuan, 333

Taiwan

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Bangkok, 10330

Thailand

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Bangkok, 10400

Thailand

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Bangkok, 10700

Thailand

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Muang, 50200

Thailand

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Udon Thani, 41330

Thailand

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Adana, 01250

Turkey (Türkiye)

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Ankara, 06100

Turkey (Türkiye)

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Ankara, 06490

Turkey (Türkiye)

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Cordaleo, 35575

Turkey (Türkiye)

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Istanbul, 32098

Turkey (Türkiye)

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Istanbul, 34214

Turkey (Türkiye)