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

Last updated: June 24, 2025
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Carboplatin + Gemcitabine

Durvalumab

Cisplatin + Gemcitabine

Clinical Study ID

NCT03682068
D933SC00001
2018-001883-48
  • Ages 18-130
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Patients with histologically or cytologically documented, unresectable, locallyadvanced or metastatic transitional cell carcinoma (transitional cell and mixedtransitional/non-transitional cell histologies) of the urothelium (including renalpelvis, ureters, urinary bladder, and urethra)

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

  • At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 targetlesion 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 forfemale pre-menopausal patients.

Exclusion

Key Exclusion Criteria:

  • Prior exposure to immune-mediated therapy (with exclusion of Bacillus CalmetteGuerin), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD L1, oranti-PD-L2 antibodies, except therapeutic anticancer vaccines, which are permitted.Prior local intervesical chemotherapy or immunotherapy is allowed if completed atleast 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 resectionduring the course of the study.

  • Any medical contraindications to platinum (cisplatin or carboplatin) based doubletchemotherapy and/or known allergy or hypersensitivity to any of the study drugs orany of the study drug excipients

Study Design

Total Participants: 1246
Treatment Group(s): 4
Primary Treatment: Carboplatin + Gemcitabine
Phase: 3
Study Start date:
September 27, 2018
Estimated Completion Date:
April 29, 2026

Connect with a study center

  • Research Site

    Buenos Aires, C1120AAT
    Argentina

    Site Not Available

  • Research Site

    Ciudad de Buenos Aires, C1419AHL
    Argentina

    Site Not Available

  • Research Site

    Rosario, S2000DEJ
    Argentina

    Site Not Available

  • Research Site

    Box Hill, 3128
    Australia

    Site Not Available

  • Research Site

    Elizabeth Vale, 5112
    Australia

    Site Not Available

  • Research Site

    Kogarah, 2217
    Australia

    Site Not Available

  • Research Site

    Macquarie University, 2109
    Australia

    Site Not Available

  • Research Site

    Murdoch, 6150
    Australia

    Site Not Available

  • Research Site

    Orange, 2800
    Australia

    Site Not Available

  • Research Site

    South Brisbane, 4101
    Australia

    Site Not Available

  • Research Site

    St Albans, 3021
    Australia

    Site Not Available

  • Research Site

    Belo Horizonte, 30380-472
    Brazil

    Site Not Available

  • Research Site

    Curitiba, 80810-050
    Brazil

    Site Not Available

  • Research Site

    Fortaleza, 60336-232
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre, 91350-200
    Brazil

    Site Not Available

  • Research Site

    Ribeirão Preto, 14048-900
    Brazil

    Site Not Available

  • Research Site

    Rio de Janeiro, 20231-050
    Brazil

    Site Not Available

  • Research Site

    Salvador, 41.950-610
    Brazil

    Site Not Available

  • Research Site

    Santa Maria, 97015-450
    Brazil

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  • Research Site

    Sao Paulo, 01327-001
    Brazil

    Site Not Available

  • Research Site

    São José do Rio Preto, 15090-000
    Brazil

    Site Not Available

  • Research Site

    São Paulo, 01246-000
    Brazil

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  • Research Site

    Burgas, 8000
    Bulgaria

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  • Research Site

    Pleven, 5800
    Bulgaria

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  • Research Site

    Plovdiv, 4000
    Bulgaria

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  • Research Site

    Sofia, 1527
    Bulgaria

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  • Research Site

    Varna, 9010
    Bulgaria

    Site Not Available

  • Research Site

    Calgary, Alberta T2N 5G2
    Canada

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  • Research Site

    Edmonton, Alberta T6G 1Z2
    Canada

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  • Research Site

    Vancouver, British Columbia V5Z 4E6
    Canada

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  • Research Site

    Hamilton, Ontario L8V 5C2
    Canada

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  • Research Site

    Ottawa, Ontario K1H 8L6
    Canada

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    Toronto, Ontario M5G IX6
    Canada

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    Montreal, Quebec H3T 1E2
    Canada

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    Sherbrooke, Quebec J1H 5N4
    Canada

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  • Research Site

    Beijing, 100191
    China

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  • Research Site

    Changchun, 130021
    China

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  • Research Site

    Changsha, 410008
    China

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  • Research Site

    Chengdu, 610072
    China

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  • Research Site

    Chongqing, 400038
    China

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  • Research Site

    Dalian, 116027
    China

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    Guangzhou, 510060
    China

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    Hangzhou, 310014
    China

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    Harbin, 150049
    China

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  • Research Site

    Hefei, 230022
    China

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  • Research Site

    Jinan, 250012
    China

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  • Research Site

    Nanchang, 330006
    China

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  • Research Site

    Nanjing, 2100008
    China

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    Shanghai, 200032
    China

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    Shenyang, 110001
    China

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    Suzhou, 215006
    China

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  • Research Site

    Tianjin,
    China

    Site Not Available

  • Research Site

    Urumqi, 830000
    China

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  • Research Site

    Wuhan, 430022
    China

    Site Not Available

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    Xi'an, 710061
    China

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    Xiamen, 361003
    China

    Site Not Available

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    Zhengzhou, 450052
    China

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    Brno, 656 91
    Czechia

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  • Research Site

    Hradec Kralove, 500 05
    Czechia

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    Olomouc, 77900
    Czechia

    Site Not Available

  • Research Site

    Ostrava, 708 52
    Czechia

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  • Research Site

    Praha, 140 59
    Czechia

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  • Research Site

    Praha 2, 128 08
    Czechia

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  • Research Site

    Praha 8, 180 81
    Czechia

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  • Research Site

    Budapest, 1122
    Hungary

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  • Research Site

    Debrecen, 4032
    Hungary

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  • Research Site

    Gyula, 5700
    Hungary

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  • Research Site

    Györ, 9024
    Hungary

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  • Research Site

    Győr, 9024
    Hungary

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  • Research Site

    Kecskemét, 6000
    Hungary

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  • Research Site

    Szolnok, 5000
    Hungary

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  • Research Site

    Ahmedabad, 380015
    India

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  • Research Site

    Bangalore, 560055
    India

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  • Research Site

    Calicut, 673601
    India

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  • Research Site

    Gurgaon, 122001
    India

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  • Research Site

    Hubli, 580025
    India

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  • Research Site

    Hyderabad, 500084
    India

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    Kolkata, 700160
    India

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    Mangalore, 575018
    India

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  • Research Site

    Mysuru, 570017
    India

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  • Research Site

    Nagpur, 440012
    India

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    Nasik, 422005
    India

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    New Delhi, 110085
    India

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  • Research Site

    Pune, 411004
    India

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    Vadodara, 390007
    India

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  • Research Site

    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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    Arezzo, 52100
    Italy

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    Catania, 95126
    Italy

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    Milano, 20132
    Italy

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    Napoli, 80131
    Italy

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    Orbassano, 10043
    Italy

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    Parma, 43126
    Italy

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  • Research Site

    Pavia, 27100
    Italy

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  • Research Site

    Roma, 00100
    Italy

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  • Research Site

    San Giovanni Rotondo, 71013
    Italy

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  • Research Site

    Terni, 05100
    Italy

    Site Not Available

  • Research Site

    Verona, 37134
    Italy

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  • Research Site

    Bunkyo-ku, 113-8603
    Japan

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  • Research Site

    Chuo-ku, 104-0045
    Japan

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  • Research Site

    Fukuoka-shi, 811-1347
    Japan

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  • Research Site

    Hirosaki-shi, 036-8563
    Japan

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  • Research Site

    Kanazawa-shi, 920-8641
    Japan

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  • Research Site

    Kita-gun, 761-0793
    Japan

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  • Research Site

    Koshigaya-shi, 343-8555
    Japan

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  • Research Site

    Koto-ku, 135-8550
    Japan

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  • Research Site

    Kumamoto-shi, 860-0008
    Japan

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  • Research Site

    Kyoto-shi, 606-8507
    Japan

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  • Research Site

    Miyazaki-city, 889-1692
    Japan

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  • Research Site

    Nagasaki-shi, 852-8501
    Japan

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  • Research Site

    Nagoya-shi, 467-0001
    Japan

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  • Research Site

    Niigata-shi, 951-8520
    Japan

    Site Not Available

  • Research Site

    Osaka-shi, 545-8586
    Japan

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  • Research Site

    Osakasayama-shi, 589-8511
    Japan

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  • Research Site

    Shinjuku-ku, 160-8582
    Japan

    Site Not Available

  • Research Site

    Suita-shi, 565-0871
    Japan

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  • Research Site

    Toyama-shi, 930-0194
    Japan

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  • Research Site

    Tsukuba-shi, 305-8576
    Japan

    Site Not Available

  • Research Site

    Yokohama-shi, 232-0024
    Japan

    Site Not Available

  • Research Site

    Goyang-si, 10408
    Korea, Republic of

    Site Not Available

  • Research Site

    Incheon, 21565
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul, 02841
    Korea, Republic of

    Site Not Available

  • Research Site

    Suwon, 16247
    Korea, Republic of

    Site Not Available

  • Research Site

    Suwon-si, 442-723
    Korea, Republic of

    Site Not Available

  • Research Site

    Bacolod, 6100
    Philippines

    Site Not Available

  • Research Site

    Baguio City, 2600
    Philippines

    Site Not Available

  • Research Site

    Cebu, 6000
    Philippines

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  • Research Site

    Davao City, 8000
    Philippines

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  • Research Site

    Iloilo City,
    Philippines

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  • Research Site

    Legazpi City, 4500
    Philippines

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  • Research Site

    Makati, 1229
    Philippines

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  • Research Site

    Manila, 1015
    Philippines

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  • Research Site

    Quezon City, 1104
    Philippines

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  • Research Site

    Bialystok, 15-027
    Poland

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  • Research Site

    Gdańsk, 80-952
    Poland

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  • Research Site

    Grudziądz, 86-300
    Poland

    Site Not Available

  • Research Site

    Koszalin, 75-581
    Poland

    Site Not Available

  • Research Site

    Kraków, 31-501
    Poland

    Site Not Available

  • Research Site

    Lublin, 20-090
    Poland

    Site Not Available

  • Research Site

    Olsztyn, 10-228
    Poland

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  • Research Site

    Otwock, 05-400
    Poland

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  • Research Site

    Poznan, 60-693
    Poland

    Site Not Available

  • Research Site

    Radom, 26-600
    Poland

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  • Research Site

    Warszawa, 02-781
    Poland

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  • Research Site

    Wroclaw, 53-413
    Poland

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  • Research Site

    Wrocław, 50-556
    Poland

    Site Not Available

  • Research Site

    Łódź, 93-509
    Poland

    Site Not Available

  • Research Site

    Ivanovo, 153040
    Russian Federation

    Site Not Available

  • Research Site

    Krasnoyarsk, 660133
    Russian Federation

    Site Not Available

  • Research Site

    Lipetsk, 398005
    Russian Federation

    Site Not Available

  • Research Site

    Moscow, 105229
    Russian Federation

    Site Not Available

  • Research Site

    Nizhniy Novgorod, 603137
    Russian Federation

    Site Not Available

  • Research Site

    Nizhny Novgorod, 603006
    Russian Federation

    Site Not Available

  • Research Site

    Omsk, 644013
    Russian Federation

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  • Research Site

    Rostov-on-Don, 344037
    Russian Federation

    Site Not Available

  • Research Site

    Ryazan, 390046
    Russian Federation

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  • Research Site

    Saint-Petersburg, 195067
    Russian Federation

    Site Not Available

  • Research Site

    St. Petersburg, 199178
    Russian Federation

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  • Research Site

    St.-Petersburg,, 198205
    Russian Federation

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  • Research Site

    St.Petersburg, 191014
    Russian Federation

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  • Research Site

    Tyumen, 625041
    Russian Federation

    Site Not Available

  • Research Site

    Vologda, 160012
    Russian Federation

    Site Not Available

  • Research Site

    Barcelona, 8003
    Spain

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  • Research Site

    Lugo, 27003
    Spain

    Site Not Available

  • Research Site

    Madrid, 28034
    Spain

    Site Not Available

  • Research Site

    Malaga, 29010
    Spain

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  • Research Site

    Santander, 39008
    Spain

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  • Research Site

    Sevilla, 41013
    Spain

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  • Research Site

    Taichung, 40705
    Taiwan

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  • Research Site

    Tainan, 704
    Taiwan

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  • Research Site

    Taipei, 11217
    Taiwan

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  • Research Site

    Taipei City, 10050
    Taiwan

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  • Research Site

    Tao-Yuan, 333
    Taiwan

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  • Research Site

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Research Site

    Bangkok, 10400
    Thailand

    Site Not Available

  • Research Site

    Chom Thon, 50200
    Thailand

    Site Not Available

  • Research Site

    Khon Kaen, 40002
    Thailand

    Site Not Available

  • Research Site

    Lampang, 52000
    Thailand

    Site Not Available

  • Research Site

    Muang, 50200
    Thailand

    Site Not Available

  • Research Site

    Mueang, 50200
    Thailand

    Site Not Available

  • Research Site

    Songkla, 90110
    Thailand

    Site Not Available

  • Research Site

    Adana, 1260
    Turkey

    Site Not Available

  • Research Site

    Adapazari, 54290
    Turkey

    Site Not Available

  • Research Site

    Ankara, 06590
    Turkey

    Site Not Available

  • Research Site

    Edirne, 22030
    Turkey

    Site Not Available

  • Research Site

    Istanbul, 34030
    Turkey

    Site Not Available

  • Research Site

    Izmir,
    Turkey

    Site Not Available

  • Research Site

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Research Site

    Bakersfield, California 93309
    United States

    Site Not Available

  • Research Site

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Research Site

    Fullerton, California 92835
    United States

    Site Not Available

  • Research Site

    Los Angeles, California 90095
    United States

    Site Not Available

  • Research Site

    Salinas, California 93901
    United States

    Site Not Available

  • Research Site

    Santa Barbara, California 93105
    United States

    Site Not Available

  • Research Site

    Santa Monica, California 90904
    United States

    Site Not Available

  • Research Site

    Truckee, California 96161
    United States

    Site Not Available

  • Research Site

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Research Site

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Research Site

    Orlando, Florida 32806
    United States

    Site Not Available

  • Research Site

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Research Site

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Research Site

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Research Site

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Research Site

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Research Site

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Research Site

    Bozeman, Montana 59715
    United States

    Site Not Available

  • Research Site

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • Research Site

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Research Site

    Bronx, New York 10467
    United States

    Site Not Available

  • Research Site

    Lake Success, New York 11042
    United States

    Site Not Available

  • Research Site

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • Research Site

    New York, New York 10065
    United States

    Site Not Available

  • Research Site

    Rochester, New York 14642
    United States

    Site Not Available

  • Research Site

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Research Site

    Sioux Falls, South Dakota 57104
    United States

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  • Research Site

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Research Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Research Site

    Ha Noi, 100000
    Vietnam

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  • Research Site

    Hanoi, 10000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh, 70000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh city,
    Vietnam

    Site Not Available

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