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BRIEF 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

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


  • Org Study ID: D933SC00001
  • Secondary ID:
  • NCT ID: NCT03682068
  • NCT Alias:
  • Sponsor: AstraZeneca - Industry
  • Source: AstraZeneca

Brief 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).

Overal Status Start Date Phase Study Type
Recruiting September 27, 2018 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Progression Free Survival (PFS)

Primary Outcome 1 - Time Frame: approximately 4 years

Primary Outcome 2 - Measure: Overall Survival (OS)

Primary Outcome 2 - Time Frame: approximately 4 years

Condition:

  • Unresectable Locally Advanced Urothelial Cancer
  • Metastatic Urothelial Cancer

Eligibility

Criteria:
Key Inclusion Criteria:

- Patients with histologically or cytologically documented, unresectable, locally
advanced or metastatic transitional cell carcinoma (transitional cell and mixed
transitional/non-transitional cell histologies) of the urothelium (including renal
pelvis, ureters, urinary bladder, and urethra)

- Patients who have not been previously treated with first-line chemotherapy. Patients
who have received prior definitive chemoradiation, adjuvant or neoadjuvant treatment
for locally advanced disease are eligible provided that progression to locally
advanced or metastatic disease has occurred >12 months from the last therapy [for
chemoradiation and adjuvant treatment] or >12 months from the last surgery [for
neoadjuvant treatment].

- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target
lesion at baseline.

- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance
status (PS) of 0 or 1 at enrolment

- Adequate organ and marrow function as defined in the protocol

- Life expectancy ≥12 weeks in the opinion of the investigator

- Evidence of post-menopausal status, or negative urinary or serum pregnancy test for
female pre-menopausal patients.

Key Exclusion Criteria:

- Prior exposure to immune-mediated therapy (with exclusion of Bacillus Calmette
Guerin), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD L1, or
anti-PD-L2 antibodies, except therapeutic anticancer vaccines, which are permitted.
Prior local intervesical chemotherapy or immunotherapy is allowed if completed at
least 28 days prior to the initiation of study treatment.

- No severe concomitant condition that requires immunosuppression medication

- Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis

- Patients who may be eligible for or are being considered for radical resection during
the course of the study.

- Any medical contraindications to platinum (cisplatin or carboplatin) based doublet
chemotherapy and/or known allergy or hypersensitivity to any of the study drugs or any
of the study drug excipients
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Gender: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Healthy Volunteers: No

Overall Contact

Name: AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Locations

Facility Status Contact
Research Site
Birmingham, Alabama 35294
United States
Not yet recruiting
Research Site
Bakersfield, California 93309
United States
Not yet recruiting
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Fountain Valley, California 92708
United States
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Fullerton, California 92835
United States
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Los Angeles, California 90095
United States
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Salinas, California 93901
United States
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Santa Barbara, California 93105
United States
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Santa Maria, California 93454
United States
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Truckee, California 96161
United States
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New Haven, Connecticut 06520
United States
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Orlando, Florida 32806
United States
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Chicago, Illinois 60611
United States
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Fort Wayne, Indiana 46808
United States
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Kansas City, Kansas 66160
United States
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Louisville, Kentucky 40202
United States
Recruiting
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New Orleans, Louisiana 70112
United States
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Bozeman, Montana 59718
United States
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Livingston, New Jersey 07039
United States
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Neptune, New Jersey 07753
United States
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Bronx, New York 10467
United States
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Lake Success, New York 11042
United States
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New York, New York 10029
United States
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New York, New York 10065
United States
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Rochester, New York 14642
United States
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Germantown, Tennessee 38138
United States
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Fort Worth, Texas 76104
United States
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Box Hill, 3128
Australia
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Elizabeth Vale, 5112
Australia
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Kogarah, 2217
Australia
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Macquarie University, 2109
Australia
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Murdoch, 6150
Australia
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South Brisbane, 4101
Australia
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St Albans, 3021
Australia
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Fortaleza, 60810-180
Brazil
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Porto Alegre, 90020-090
Brazil
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Porto Alegre, 91350-200
Brazil
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Ribeirão Preto, 14048-900
Brazil
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Rio de Janeiro, 22793-080
Brazil
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São José do Rio Preto, 15090-000
Brazil
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Burgas, 8000
Bulgaria
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Pleven, 5800
Bulgaria
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Plovdiv, 4000
Bulgaria
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Sofia, 1303
Bulgaria
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Sofia, 1431
Bulgaria
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Sofia, 1797
Bulgaria
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Varna,
Bulgaria
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Edmonton, Alberta T6G 1Z2
Canada
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Vancouver, British Columbia V5Z 4E6
Canada
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Hamilton, Ontario L8V 5C2
Canada
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Ottawa, Ontario K1H 8L6
Canada
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Toronto, Ontario M5G 2M9
Canada
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Brno, 656 91
Czechia
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Hradec Kralove, 500 05
Czechia
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Olomouc, 779 00
Czechia
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Ostrava, 708 52
Czechia
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Praha 2, 128 08
Czechia
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Praha, 140 59
Czechia
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Praha, 180 81
Czechia
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Budapest, 1062
Hungary
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Budapest, 1122
Hungary
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Budapest, 1145
Hungary
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Györ, 9024
Hungary
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Kecskemét, 6000
Hungary
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Szolnok, 5004
Hungary
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Haifa, 31096
Israel
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Jerusalem, 91120
Israel
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Kfar Saba, 95847
Israel
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Petach-Tikva, 4941492
Israel
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Ramat Gan, 52621
Israel
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Milano, 20133
Italy
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Napoli, 80131
Italy
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Orbassano, 10043
Italy
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Parma, 43100
Italy
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Pavia, 27100
Italy
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San Giovanni Rotondo, 71013
Italy
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Terni, 05100
Italy
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Bunkyo-ku, 113-8603
Japan
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Hirosaki-shi, 036-8563
Japan
Recruiting
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Kanazawa-shi, 920-8641
Japan
Recruiting
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Kita-gun, 761-0793
Japan
Not yet recruiting
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Koshigaya-shi, 343-8555
Japan
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Koto-ku, 135-8550
Japan
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Kyoto-shi, 606-8507
Japan
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Miyazaki-city, 889-1692
Japan
Recruiting
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Nagasaki-shi, 852-8501
Japan
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Niigata-shi, 951-8520
Japan
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Osaka-shi, 541-8567
Japan
Recruiting
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Osaka-shi, 545-0051
Japan
Recruiting
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Osakasayama-shi, 589-8511
Japan
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Shinjuku-ku, 160-8582
Japan
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Suita-shi, 565-0871
Japan
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Toyama-shi, 930-0194
Japan
Recruiting
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Tsukuba-shi, 305-8576
Japan
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Yokohama-shi, 232-0024
Japan
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Goyang-si, 10408
Korea, Republic of
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Incheon, 21565
Korea, Republic of
Recruiting
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Seoul, 02841
Korea, Republic of
Recruiting
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Seoul, 03722
Korea, Republic of
Recruiting
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Seoul, 05505
Korea, Republic of
Recruiting
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Seoul, 06351
Korea, Republic of
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Suwon-si, 442-723
Korea, Republic of
Recruiting
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Bacolod, 6100
Philippines
Not yet recruiting
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Baguio City, 2600
Philippines
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Cebu, 6000
Philippines
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Davao City, 8000
Philippines
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Makati, 1229
Philippines
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Manila,
Philippines
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Quezon City, 1104
Philippines
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Bialystok, 15-027
Poland
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Gdańsk, 80-952
Poland
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Grudziądz, 86-300
Poland
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Koszalin, 75-581
Poland
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Lublin, 20-090
Poland
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Warszawa, 02-616
Poland
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Warszawa, 02-781
Poland
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Wroclaw, 53-413
Poland
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Łódź, 93-509
Poland
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Ivanovo, 153040
Russian Federation
Recruiting
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Krasnoyarsk, 660133
Russian Federation
Recruiting
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Moscow, 105229
Russian Federation
Recruiting
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Moscow, 115280
Russian Federation
Not yet recruiting
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Moscow, 125367
Russian Federation
Withdrawn
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Nizhny Novgorod, 603006
Russian Federation
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Omsk, 644013
Russian Federation
Recruiting
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Rostov-on-Don, 344037
Russian Federation
Recruiting
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Saint-Petersburg, 195067
Russian Federation
Not yet recruiting
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St. Petersburg, 199178
Russian Federation
Recruiting
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St.-Petersburg,, 198205
Russian Federation
Withdrawn
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Vologda, 160012
Russian Federation
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Barcelona, 08908
Spain
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Barcelona, 8003
Spain
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Barcelona, 8035
Spain
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Lugo, 27003
Spain
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Madrid, 28034
Spain
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Madrid, 28040
Spain
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Malaga, 29010
Spain
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Santander, 39008
Spain
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Sevilla, 41013
Spain
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Taichung, 404
Taiwan
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Taichung, 40705
Taiwan
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Taipei City, 10050
Taiwan
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Taipei, 11217
Taiwan
Recruiting
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Bangkok, 10300
Thailand
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Bangkok, 10400
Thailand
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Chom Thon, 50200
Thailand
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Adana, 1260
Turkey
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Adapazari, 54290
Turkey
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Ankara, 06590
Turkey
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Edirne, 22030
Turkey
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Istanbul, 34030
Turkey
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Izmir,
Turkey
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Ha Noi, 100000
Vietnam
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Ho Chi Minh city,
Vietnam
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