A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | November 16, 2018 | Phase 3 | Interventional |
Primary Outcome 1 - Measure: Pathologic complete response (pCR) rates at time of cystectomy
Primary Outcome 1 - Time Frame: Up to 6 months
Primary Outcome 2 - Measure: Event-free survival (EFS) per central review defined as time from randomization to event
Primary Outcome 2 - Time Frame: Up to 48 months
Criteria:
Inclusion:
- Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0
with transitional and mixed transitional cell histology
- Patients must be planning to undergo a radical cystectomy
- Patients who have not received prior systemic chemotherapy or immunotherapy for
treatment of MIBC
- ECOG performance status of 0 or 1
- Must have a life expectancy of at least 12 weeks at randomization
Exclusion:
- Evidence of lymph node (N2-N3) or metastatic (M1) disease at time of screening.
- Prior pelvic radiotherapy treatment within 2 years of randomization to study
- Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin
[BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or
anti-PD-L2 antibodies.
- Current or prior use of immunosuppressive medication within 14 days before the first
dose of investigational product (IP). The following are exceptions to this criterion:
Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra
articular injection); Systemic corticosteroids at physiologic doses not to exceed 10
mg/day of prednisone or its equivalent; Steroids as premedication for hypersensitivity
reactions (eg, CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
- Uncontrolled intercurrent illness
- Active infection including Tuberculosis, Hepatitis B, Hepatitis C, and Human
Immunodeficiency
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Gender: All
Minimum Age: 18 Years
Maximum Age: 130 Years
Healthy Volunteers: No
Name: AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
Email: information.center@astrazeneca.com
Facility | Status | Contact |
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Research Site Birmingham, Alabama 35294 United States |
Recruiting | |
Research Site Los Angeles, California 90095 United States |
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Research Site Palo Alto, California 94304 United States |
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Research Site New Haven, Connecticut 06520 United States |
Recruiting | |
Research Site Chicago, Illinois 60611 United States |
Recruiting | |
Research Site Geneva, Illinois 60134 United States |
Not yet recruiting | |
Research Site Iowa City, Iowa 52242 United States |
Recruiting | |
Research Site Westwood, Kansas 66205 United States |
Recruiting | |
Research Site Louisville, Kentucky 40202 United States |
Recruiting | |
Research Site New Orleans, Louisiana 70112 United States |
Suspended | |
Research Site Baltimore, Maryland 21204 United States |
Terminated | |
Research Site Ann Arbor, Michigan 48109 United States |
Recruiting | |
Research Site Detroit, Michigan 48201 United States |
Recruiting | |
Research Site New York, New York 10029 United States |
Recruiting | |
Research Site Rochester, New York 14642 United States |
Recruiting | |
Research Site Bethlehem, Pennsylvania 18015 United States |
Suspended | |
Research Site Burlington, Vermont 05401 United States |
Recruiting | |
Research Site Milwaukee, Wisconsin 53226 United States |
Recruiting | |
Research Site Brisbane, 4122 Australia |
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Research Site Elizabeth Vale, 5112 Australia |
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Research Site Macquarie University, 2109 Australia |
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Research Site Melbourne, 3004 Australia |
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Research Site Murdoch, 6150 Australia |
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Research Site South Brisbane, 4101 Australia |
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Research Site Brugge, 8000 Belgium |
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Research Site Charleroi, 6000 Belgium |
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Research Site Kortrijk, 8500 Belgium |
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Research Site Leuven, 3000 Belgium |
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Research Site Liège, 4000 Belgium |
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Research Site Roeselare, 8800 Belgium |
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Research Site Barretos, 14784-400 Brazil |
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Research Site Porto Alegre, 90020-090 Brazil |
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Research Site Porto Alegre, 90470-340 Brazil |
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Research Site Porto Alegre, 90610-000 Brazil |
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Research Site Porto Alegre, 91350-200 Brazil |
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Research Site Rio de Janeiro, 20231-050 Brazil |
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Research Site Santa Maria, 97015-450 Brazil |
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Research Site Sao Paulo, 01323-903 Brazil |
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Research Site Sao Paulo, 01509-900 Brazil |
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Research Site São José do Rio Preto, 15090-000 Brazil |
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Research Site São Paulo, 01246-000 Brazil |
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Research Site São Paulo, 03102-002 Brazil |
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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 |
Withdrawn | |
Research Site London, Ontario N6A 5W9 Canada |
Terminated | |
Research Site Ottawa, Ontario K1H 8L6 Canada |
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Research Site Toronto, Ontario M5G IX6 Canada |
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Research Site Montreal, Quebec H2X 0C2 Canada |
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Research Site Sherbrooke, Quebec J1H 5N4 Canada |
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Research Site Antofagasta, 1267348 Chile |
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Research Site Puerto Montt, 5480000 Chile |
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Research Site Santiago, 7520349 Chile |
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Research Site Temuco, 4810218 Chile |
Terminated | |
Research Site Temuco, 4810469 Chile |
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Research Site Viña del Mar, 2540488 Chile |
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Research Site Brno, 656 53 Czechia |
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Research Site Brno, 656 91 Czechia |
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Research Site Hradec Kralove, 500 05 Czechia |
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Research Site Olomouc, 779 00 Czechia |
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Research Site Praha 2, 128 08 Czechia |
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Research Site Praha 5, 150 06 Czechia |
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Research Site Praha, 140 59 Czechia |
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Research Site Praha, 180 81 Czechia |
Terminated | |
Research Site Angers Cedex 01, 49033 France |
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Research Site Dijon, 21079 France |
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Research Site Grenoble Cedex 09, 38043 France |
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Research Site Montpellier, 34070 France |
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Research Site Nimes, 30029 France |
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Research Site Pierre Benite, 69495 France |
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Research Site Poitiers Cedex, 86021 France |
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Research Site Rouen, F-76031 CE France |
Terminated | |
Research Site Bergisch Gladbach, 51465 Germany |
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Research Site Bonn, 53127 Germany |
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Research Site Erlangen, 91054 Germany |
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Research Site Göttingen, 37075 Germany |
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Research Site Herne, 44625 Germany |
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Research Site Jena, 07747 Germany |
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Research Site Köln, 50937 Germany |
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Research Site Magdeburg, 39120 Germany |
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Research Site Mannheim, 68167 Germany |
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Research Site Münster, 48149 Germany |
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Research Site Nürnberg, 90491 Germany |
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Research Site Oldenburg, 23758 Germany |
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Research Site Regensburg, 93053 Germany |
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Research Site Ulm, 89081 Germany |
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Research Site Würzburg, 97080 Germany |
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Research Site Haifa, 31096 Israel |
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Research Site Jerusalem, 91120 Israel |
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Research Site Kfar Saba, 95847 Israel |
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Research Site Petach-Tikva, 4941492 Israel |
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Research Site Ramat Gan, 52621 Israel |
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Research Site Bari, 70124 Italy |
Recruiting | |
Research Site Bologna, 40138 Italy |
Not yet recruiting | |
Research Site Firenze, 50134 Italy |
Recruiting | |
Research Site Milano, 20132 Italy |
Not yet recruiting | |
Research Site Milano, 20133 Italy |
Recruiting | |
Research Site Napoli, 80131 Italy |
Recruiting | |
Research Site Orbassano, 10043 Italy |
Recruiting | |
Research Site Verona, 37126 Italy |
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Research Site Bunkyo-ku, 113-8603 Japan |
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Research Site Fukuoka-shi, 811-1347 Japan |
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Research Site Fukuoka, 812-8582 Japan |
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Research Site Hirosaki-shi, 036-8563 Japan |
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Research Site Hiroshima-shi, 730-8518 Japan |
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Research Site Kanazawa-shi, 920-8641 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 Miyazaki-city, 889-1692 Japan |
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Research Site Nagasaki-shi, 852-8501 Japan |
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Research Site Nagoya-shi, 466-8560 Japan |
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Research Site Niigata-shi, 951-8520 Japan |
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Research Site Osaka-shi, 541-8567 Japan |
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Research Site Osaka-shi, 545-8586 Japan |
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Research Site Osakasayama-shi, 589-8511 Japan |
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Research Site Sendai-shi, 980-0872 Japan |
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Research Site Toyama-shi, 930-0194 Japan |
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Research Site Tsukuba-shi, 305-8576 Japan |
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Research Site Yokohama-shi, 232-0024 Japan |
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Research Site Yokohama-shi, 241-8515 Japan |
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Research Site Daegu, 41404 Korea, Republic of |
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Research Site Goyang-si, 10408 Korea, Republic of |
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Research Site Incheon, 21565 Korea, Republic of |
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Research Site Seongnam, 13620 Korea, Republic of |
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Research Site Seoul, 03080 Korea, Republic of |
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Research Site Seoul, 05505 Korea, Republic of |
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Research Site Seoul, 136-705 Korea, Republic of |
Terminated | |
Research Site Amsterdam, 1066 CX Netherlands |
Recruiting | |
Research Site Amsterdam, 1081 HV Netherlands |
Terminated | |
Research Site Breda, 4818 CK Netherlands |
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Research Site Rotterdam, 3015 GD Netherlands |
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Research Site Baguio City, 2600 Philippines |
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Research Site Cebu, 6000 Philippines |
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Research Site Davao City, 8000 Philippines |
Recruiting | |
Research Site Makati, 1229 Philippines |
Suspended | |
Research Site Manila, 1015 Philippines |
Suspended | |
Research Site Quezon City, 1101 Philippines |
Recruiting | |
Research Site Quezon City, 1104 Philippines |
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Research Site Bialystok, 15-027 Poland |
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Research Site Gdańsk, 80-214 Poland |
Recruiting | |
Research Site Grudziądz, 86-300 Poland |
Suspended | |
Research Site Koszalin, 75-581 Poland |
Recruiting | |
Research Site Kraków, 30-510 Poland |
Not yet recruiting | |
Research Site Olsztyn, 10-228 Poland |
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Research Site Ostrołęka, 07-410 Poland |
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Research Site Poznan, 60-693 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 Krasnoyarsk, 660133 Russian Federation |
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Research Site Moscow, 105077 Russian Federation |
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Research Site Nizhniy Novgorod, 603074 Russian Federation |
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Research Site Novosibirsk, 630007 Russian Federation |
Recruiting | |
Research Site Samara, 443031 Russian Federation |
Suspended | |
Research Site St Petersburg, 194044 Russian Federation |
Not yet recruiting | |
Research Site St. Petersburg, 194017 Russian Federation |
Suspended | |
Research Site St. Petersburg, 194354 Russian Federation |
Suspended | |
Research Site Vologda, 160012 Russian Federation |
Suspended | |
Research Site Badalona, 08916 Spain |
Recruiting | |
Research Site Barcelona, 08035 Spain |
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Research Site Córdoba, 14004 Spain |
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Research Site Las Palmas de Gran Canaria, 35016 Spain |
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Research Site Madrid, 28007 Spain |
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Research Site Madrid, 28041 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 Kaohsiung, 807 Taiwan |
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Research Site Taichung, 40443 Taiwan |
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Research Site Taichung, 40705 Taiwan |
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Research Site Tainan, 704 Taiwan |
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Research Site Tainan, 710 Taiwan |
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Research Site Taipei City, 10050 Taiwan |
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Research Site Taipei, 11217 Taiwan |
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Research Site Taoyuan, 333 Taiwan |
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Research Site Ankara, 06590 Turkey |
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Research Site Edirne, 22030 Turkey |
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Research Site Istanbul, 34030 Turkey |
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Research Site Izmir, Turkey |
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Research Site Edinburgh, EH4 2XR United Kingdom |
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Research Site London, E1 1BB United Kingdom |
Recruiting | |
Research Site Nottingham, NG5 1PB United Kingdom |
Suspended | |
Research Site Sheffield, S10 2SJ United Kingdom |
Recruiting | |
Research Site Wirral, CH63 4JY United Kingdom |
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Research Site Hanoi, 100000 Vietnam |
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Research Site Ho Chi Minh, 700000 Vietnam |
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Research Site Hochiminh, 70000 Vietnam |
Recruiting |