A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
Study Purpose
The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 12 Years and Over |
Gender | All |
Inclusion Criteria:
- - Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only) - Histologically confirmed stage III (unresectable) or stage IV melanoma.
- - Treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant and/or neoadjuvant treatment for melanoma with approved agents.
Exclusion Criteria:
- - Active brain metastases or leptomeningeal metastases.
- - Uveal melanoma.
- - Participants with an active, known or suspected autoimmune disease.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03635983 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Bristol-Myers Squibb |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Bristol-Myers Squibb |
Principal Investigator Affiliation | Bristol-Myers Squibb |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Active, not recruiting |
Countries | Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Spain, Sweden, Switzerland, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Melanoma |
Study Website: | View Trial Website |
Arms
Experimental: Combination
NKTR-214 + Nivolumab
Experimental: Monotherapy
Nivolumab
Interventions
Biological: - NKTR-214
Specified dose on specified days
Biological: - Nivolumab
Specified dose on specified days
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
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Local Institution - 0187
Tucson, Arizona, 85724
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Local Institution - 0014
La Jolla, California, 92093
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Local Institution - 0122
Stanford, California, 94305
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Local Institution - 0051
Aurora, Colorado, 80045
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Local Institution - 0065
New Haven, Connecticut, 06510
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Local Institution - 0017
Miami Beach, Florida, 33140
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Local Institution - 0153
Miami, Florida, 33136
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Local Institution - 0112
Tampa, Florida, 33612
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Local Institution - 0012
Atlanta, Georgia, 30322-1013
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Local Institution - 0019
Louisville, Kentucky, 40202
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Local Institution - 0018
Boston, Massachusetts, 02215
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Local Institution - 0188
Ann Arbor, Michigan, 48109
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Local Institution - 0186
Fridley, Minnesota, 55432
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Local Institution - 0135
Saint Louis, Missouri, 63110
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Local Institution - 0016
Hackensack, New Jersey, 07601
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Local Institution - 0185
New Brunswick, New Jersey, 08903
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Local Institution - 0141
New York, New York, 10065
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Local Institution - 0037
Cleveland, Ohio, 44195
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Local Institution - 0011
Portland, Oregon, 97213
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Local Institution - 0013
Portland, Oregon, 97239
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St. Luke's Hospital & Health Network
Easton, Pennsylvania, 18045
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Local Institution - 0015
Philadelphia, Pennsylvania, 19111
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Local Institution - 0001
Houston, Texas, 77030
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Local Institution - 0064
Fairfax, Virginia, 22031
International Sites
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Local Institution - 0109
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1430
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Local Institution - 0107
Buenos Aires, Ciudad Autónoma De Buenos Aires, C1118AAT
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Local Institution - 0183
Buenos Aires, Distrito Federal, C1017
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Local Institution - 0108
Caba, , 1426
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Local Institution - 0157
Cordoba, , 5000
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Local Institution - 0146
Coffs Harbour, New South Wales, 2450
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Local Institution - 0053
North Sydney, New South Wales, 2060
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Local Institution - 0058
Cairns, Queensland, 4870
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Local Institution
Greenslopes, Queensland, 4120
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Local Institution - 0056
Woolloongabba, Queensland, 4102
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Local Institution - 0172
Elizabeth Vale, South Australia, 5112
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Local Institution - 0054
Melbourne, Victoria, 3000
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Local Institution - 0143
Melbourne, Victoria, 3004
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Local Institution - 0057
Nedlands, Western Australia, 6009
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Local Institution - 0097
Nedlands, Western Australia, 6009
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Local Institution - 0034
Graz, , 8036
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Local Institution - 0035
Salzburg, , 5020
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Local Institution - 0033
Wien, , 1090
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Local Institution - 0083
Bruxelles, , 1000
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Local Institution - 0084
Hasselt, , 3500
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Local Institution - 0085
Leuven, , B-3000
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Local Institution - 0168
Fortaleza, Ceara, 60130-241
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Local Institution - 0125
Belo Horizonte, Minas Gerais, 30130-090
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Local Institution - 0124
Ijui, RIO Grande DO SUL, 98700-000
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Local Institution - 0127
Porto Alegre, RIO Grande DO SUL, 90610-000
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Local Institution - 0171
Itajai, Santa Catarina, 88301-220
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Local Institution - 0126
Barretos, Sao Paulo, 14780-070
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Local Institution - 0182
Rio De Janeiro, , 20231-050
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Local Institution - 0169
Sao Paulo, , 01509-010
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Local Institution - 0068
Abbotsford, British Columbia, V2S 0C2
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Local Institution - 0139
St. John's, Newfoundland and Labrador, A1B 3V6
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Local Institution - 0066
Hamilton, Ontario, L8V 5C2
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Local Institution - 0067
Kitchener, Ontario, N2G 1G3
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Local Institution - 0041
Toronto, Ontario, M5G 2M9
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Local Institution - 0121
Edmonton, , T6X 1E8
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Quebec, , G1R 2J6
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Local Institution - 0174
Recoleta, Metropolitana, 0
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Local Institution - 0173
Santiago, Metropolitana, 8330024
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Local Institution - 0094
Brno, , 656 53
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Local Institution - 0093
Hradec Kralove, , 500 05
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Local Institution - 0091
Praha 10, , 100 34
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Local Institution - 0092
Praha 2, , 128 08
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Local Institution - 0166
Tampere, Oulun Lääni, FI-33520
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Local Institution - 0167
KYS, , 70029
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Local Institution - 0165
Turku, , 20520
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Centre Hospitalier Universitaire de Bordeaux Hospital Saint Andre
Bordeaux, , 33075
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Hopital Claude Huriez
Lille, , 59000
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Hopital Saint Eloi
Montpellier Cedex 05, , 34295
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Hotel Dieu - Chu De Nantes
Nantes Cedex 1, , 44093
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Chu De Nice Hopital De Cimiez
Nice, , 06200
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Hopital Saint Louis
Paris, , 75475
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Centre Hospitalier Lyon Sud
Pierre Benite, , 69310
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CHU Charles Nicolle
Rouen, , 76000
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Hopital Nord - CHU de Saint-Etienne
Saint Priest en Jarez, , 42270
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Institut Claudius Regaud
Toulouse Cedex 9, , 31059
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Institute Gustave Roussy
Villejuif, , 94805
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Local Institution - 0031
Buxtehude, , 21614
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Local Institution - 0029
Dresden, , 01307
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Local Institution - 0192
Erfurt, , 99089
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Local Institution - 0026
Essen, , 45147
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Local Institution - 0030
Goettingen, , 37075
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Local Institution - 0023
Hamburg, , 20251
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Local Institution - 0024
Hannover, , D30625
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Local Institution - 0020
Heidelberg, , 69120
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Local Institution - 0028
Kiel, , 24105
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Local Institution - 0022
Leipzig, , 04103
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Local Institution - 0021
Muenchen, , 80337
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Local Institution - 0027
Münster, , 48157
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Local Institution - 0060
Regensburg, , 93053
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Local Institution - 0025
Tuebingen, , 72076
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Local Institution - 0032
Wuerzburg, , 97080
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Local Institution - 0038
Athens, , 11526
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Local Institution - 0039
Neo Faliro, , 18547
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Local Institution - 0040
Thessaloniki, , 57001
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Local Institution - 0136
Wilton, Cork, 0
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Local Institution - 0129
Dublin 7, Dublin, 0
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Local Institution - 0128
Dublin, , 4
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Local Institution - 0130
Dublin, , Dublin 7
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Local Institution - 0098
Beer Sheva, , 84101
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Local Institution - 0088
Jerusalem, , 91120
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Local Institution - 0089
Ramat-gan, , 52621
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Istituto Europeo di Oncologia IRCCS
Milan, Lombardia, 20141
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Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino, Piemonte, 10126
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IRCCS Giovanni Paolo II Istituto Oncologico
Bari, , 70124
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ASST Papa Giovanni XXIII
Bergamo, , 24127
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IRST Meldola
Meldola (fc), , 47014
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IRCCS Istituto Nazionale Tumori Milano
Milano, , 20133
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Instituto Nazionale Tumori Fondazione G. Pascale
Napoli, , 80131
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Istituto Oncologico Veneto IOV
Padova, , 35128
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Azienda Ospedaliera Universitaria Senese
Siena, , 53100
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Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Torino, , 10060
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Local Institution - 0175
Ciudad de Mexico, Distrito Federal, 03100
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Local Institution - 0176
Zapopan, Jalisco, 45070
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Local Institution - 0177
Monterrey, Nuevo LEON, 64460
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Local Institution - 0180
Monterrey, Nuevo LEON, 64710
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Local Institution - 0178
Cancún, Quintana Roo, 77500
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Local Institution - 0179
Puebla, , 72424
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Local Institution - 0181
San Luis Potosi, , 78200
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Local Institution - 0101
Amsterdam, , 1066CX
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Local Institution - 0102
Amsterdam, , 1081 HV
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Local Institution - 0099
Leiden, , 2333 ZA
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Local Institution - 0100
Nijmegen, , 6525 GA
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Local Institution - 0147
Untrecht, , 3584CX
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Local Institution - 0159
Auckland, , 1142
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Local Institution - 0063
Christchurch, , 8011
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Local Institution - 0062
Wellington, , 6021
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Local Institution - 0152
Bydgoszcz, , 85-796
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Local Institution - 0090
Warszawa, , 02-781
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Local Institution - 0134
Lisboa, , 1649-035
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Local Institution - 0133
Porto, , 4200-072
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Local Institution - 0162
Bucharest, , 022328
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Local Institution - 0070
Cluj-Napoca, , 400015
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Local Institution - 0071
Craiova, , 200542
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Local Institution - 0120
Floresti, , 407280
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Local Institution - 0149
Krasnoyarsk, , 660133
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Local Institution - 0086
Moscow, , 105229
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Local Institution - 0111
Moscow, , 115478
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Local Institution - 0148
Moscow, , 121309
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Local Institution - 0116
Barcelona, , 08035
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Local Institution - 0115
Barcelona, , 08036
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Cordoba, , 14004
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Local Institution - 0190
Doniostia - San Sebastian, , 20014
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Donostia, , 20014
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Local Institution - 0118
Jaén, , 23007
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Local Institution - 0114
Madrid, , 28007
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Local Institution - 0119
Santiago Compostela, , 15706
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Local Institution - 0117
Valencia, , 46014
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Local Institution - 0163
Gothenburg, , 413 45
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Local Institution - 0164
Lund, , 222 42
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Local Institution - 0104
Bern, , 3010
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Local Institution - 0105
Lausanne, , 1011
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Local Institution - 0036
Zuerich, , 8091
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Local Institution - 0132
Southampton, Hampshire, SO16 6YD
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Edinburgh, Midlothian, EH16 4SB
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Local Institution - 0131
Sutton., Surrey, SM25PT
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Local Institution - 0078
Belfast, , BT9 7AB
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Local Institution - 0076
Cambridge, , CB2 0QQ
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Local Institution - 0079
Cottingham, , HU16 5JQ
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Local Institution - 0137
Liverpool, , L7 8YA
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Local Institution - 0077
London, , SW17 0RE
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Local Institution - 0074
London, , SW36JJ
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Local Institution - 0075
Manchester, , M20 4BX
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Local Institution - 0142
Tauton, , TA1 5DA