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A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
Study Purpose
The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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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.
- - Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of age).
- - Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.
- - Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- - Participants must be ≥ 12 years of age.
- - Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).
- - Participants must not have ocular melanoma.
- - Participants must not have a history of myocarditis, regardless of etiology.
- - Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment.
- - Other protocol-defined Inclusion/Exclusion criteria apply.
Trial Details
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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. |
NCT05625399 |
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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 | Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Finland, France, Germany, Israel, Italy, Norway, Poland, 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: Nivolumab + Relatlimab FDC SC
Active Comparator: Nivolumab + Relatlimab FDC IV
Interventions
Drug: - Nivolumab + Relatlimab
Specified dose on specified days
Drug: - rHuPH20
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.
Status
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Local Institution - 0125
Phoenix 5308655, Arizona 5551752, 85013
Status
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Local Institution - 0189
Springdale 4132093, Arkansas 4099753, 72762
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Local Institution - 0098
Los Angeles 5368361, California 5332921, 90025
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Local Institution - 0093
Orange 5379513, California 5332921, 92868-3201
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Local Institution - 0123
Stanford 5398563, California 5332921, 94305
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Local Institution - 0113
Englewood 5421250, Colorado 5417618, 80113
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Local Institution - 0114
Jacksonville 4160021, Florida 4155751, 32224
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Local Institution - 0146
Baltimore 4347778, Maryland 4361885, 21201
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Local Institution - 0071
Rochester 5043473, Minnesota 5037779, 55905
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Local Institution - 0013
Omaha 5074472, Nebraska 5073708, 68130
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Local Institution - 0169
Cleveland 5150529, Ohio 5165418, 44195
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Local Institution - 0139
Easton 5188140, Pennsylvania 6254927, 18045
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Local Institution - 0124
Philadelphia 4560349, Pennsylvania 6254927, 19107
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Local Institution - 0122
Murray 5778755, Utah 5549030, 84107
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Local Institution - 0115
Fairfax 4758023, Virginia 6254928, 22031
International Sites
Status
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Local Institution - 0050
Coffs Harbour 2171085, New South Wales 2155400, 2450
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Local Institution - 0175
Orange 2154219, New South Wales 2155400, 2800
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Local Institution - 0172
Port Macquarie 2152659, New South Wales 2155400, 2444
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Local Institution - 0118
Wagga Wagga 2145110, New South Wales 2155400, 2650
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Local Institution - 0184
Waratah 10103871, New South Wales 2155400, 2298
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Local Institution - 0033
Westmead 2143973, New South Wales 2155400, 2145
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Local Institution - 0055
Wollstonecraft 9972972, New South Wales 2155400, 2065
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Local Institution - 0090
Birtinya 8348723, Queensland 2152274, 4575
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Local Institution - 0008
Bendigo 2176187, Victoria 2145234, 3550
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Local Institution - 0059
Box Hill 2174360, Victoria 2145234, 3128
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Local Institution - 0154
Heidelberg 2163654, Victoria 2145234, 3084
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Local Institution - 0030
Melbourne 2158177, Victoria 2145234, 3004
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Local Institution - 0109
Traralgon 2146108, Victoria 2145234, 3844
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Local Institution - 0106
Nedlands 2064874, Western Australia 2058645, 6009
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Local Institution - 0161
Nedlands 2064874, Western Australia 2058645, 6009
Status
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Local Institution - 0027
Graz 2778067, , 8036
Status
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Local Institution - 0029
Salzburg 2766824, , 5020
Status
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Local Institution - 0168
Sankt Pölten 2766429, , 3100
Status
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Local Institution - 0037
Vienna 2761369, , 1090
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Local Institution - 0072
Brussels 2800866, , 1200
Status
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Local Institution - 0078
Charleroi 2800481, , 6000
Status
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Local Institution - 0016
Liège 2792413, , 4000
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Local Institution - 0177
Fortaleza 3399415, Ceará 3402362, 60135237
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Local Institution - 0180
Vitória 3444924, Espírito Santo 3463930, 29043-260
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Local Institution - 0107
Belo Horizonte 3470127, Minas Gerais 3457153, 30130-090
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Local Institution - 0025
Ijuí 3461444, Rio Grande do Sul 3451133, 98700-000
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Local Institution - 0031
Porto Alegre 3452925, Rio Grande do Sul 3451133, 90035-903
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Local Institution - 0058
Porto Alegre 3452925, Rio Grande do Sul 3451133, 90610-000
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Local Institution - 0002
Porto Alegrelegre, Rio Grande do Sul 3451133, 91350-250
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Local Institution - 0159
Blumenau 3469968, Santa Catarina 3450387, 89010-340
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Local Institution - 0009
Barretos 3470451, São Paulo 3448433, 14784-400
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Local Institution - 0018
São José do Rio Preto 3448639, São Paulo 3448433, 15090-000
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Local Institution - 0110
Rio de Janeiro 3451190, , 20220-410
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Local Institution - 0130
São Paulo 3448439, , 01321-001
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Local Institution - 0141
Calgary 5913490, Alberta 5883102, T2N 5G2
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Local Institution - 0121
Hamilton 5969782, Ontario 6093943, L8V 5C2
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Local Institution - 0096
Ottawa 6094817, Ontario 6093943, K1H 8L6
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Local Institution - 0116
Toronto 6167865, Ontario 6093943, M4N 3M5
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Local Institution - 0103
Québec 6325494, Quebec 6115047, G1J 1Z4
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Local Institution - 0178
Port Montt 3874960, Los Lagos Region 3881974, 5507642
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Local Institution - 0119
Santiago 3871336, Providencia, 7500653
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Local Institution - 0143
Temuco 3870011, Región de la Araucanía 3899463, 4800827
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Local Institution - 0028
Viña del Mar 3868121, Región de Valparaíso 3868621, 2520598
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Local Institution - 0140
Recoleta 3873635, Santiago Metropolitan 3873544, 8380455
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Local Institution - 0144
Santiago 3871336, Santiago Metropolitan 3873544, 0101010
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Local Institution - 0010
Santiago 3871336, Santiago Metropolitan 3873544, 7510032
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Local Institution - 0074
Santiago 3871336, Santiago Metropolitan 3873544, 8150513
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Local Institution - 0017
Santiago 3871336, , 7500921
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Local Institution - 0083
Prague 3067696, NY, 128 00
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Local Institution - 0094
Hradec Králové 3074967, , 500 05
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Local Institution - 0091
Olomouc 3069011, , 77900
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Local Institution - 0082
Ostrava Poruba, , 708 52
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Local Institution - 0095
Prague 3067696, , 182 00
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Local Institution - 0164
Helsinki 658225, , 00029
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Local Institution - 0167
Tampere 634963, , 33521
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Local Institution - 0162
Turku 633679, , 20520
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Local Institution - 0108
Toulouse 2972315, Cedex 9, 31059
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Local Institution - 0127
Chambray-lès-Tours 3027343, Indre-Et-Loire, 37044
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Local Institution - 0111
Lille 2998324, Nord, 59000
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Local Institution - 0063
Nantes 2990969, OH, 44093
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Local Institution - 0061
Villejuif 2968705, Val-De-Marne, 94805
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Local Institution - 0007
Amiens 3037854, , 80054
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Local Institution - 0128
Bayonne 3034475, , 64100
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Local Institution - 0022
Bordeaux 3031582, , 33000
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Local Institution - 0129
Clermont-Ferrand 3024635, , 63003
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Local Institution - 0046
Dijon 3021372, , 21079
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Local Institution - 0117
Marseille 2995469, , 13385
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Local Institution - 0052
Pierre-Bénite 2987314, , 69310
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Local Institution - 0089
Rennes 2983990, , 35042
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Local Institution - 0099
Rouen 2982652, , 76031
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Local Institution - 0034
Paris 2988507, Île-de-France Region 3012874, 75475
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Local Institution - 0101
Heidelberg 2907911, Baden-Wurttemberg 2953481, 69120
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Local Institution - 0079
Ulm 2820256, Baden-Wurttemberg 2953481, 89081
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Local Institution - 0011
Regensburg 2849483, Bavaria 2951839, 93042
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Local Institution - 0003
Lübeck 2875601, Schleswig-Holstein 2838632, 23538
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Local Institution - 0060
Berlin 2950159, , 10117
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Local Institution - 0038
Buxtehude 2940451, , 21614
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Local Institution - 0136
Dortmund 2935517, , 44137
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Local Institution - 0039
Erfurt 2929670, , 99089
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Local Institution - 0049
Essen 2928810, , 45147
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Local Institution - 0166
Frankfurt am Main 2925533, , 60590
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Local Institution - 0065
Giessen 2920512, , 35385
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Local Institution - 0135
Göttingen 2918632, , 37075
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Local Institution - 0138
Hamburg 2911298, , 20251
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Local Institution - 0137
Ludwigshafen 2875377, , 67063
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Local Institution - 0165
Marburg 2873759, , 35043
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Local Institution - 0044
Minden 2871039, , 32429
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Local Institution - 0112
Nuremberg 2861650, , 90419
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Local Institution - 0053
Rostock 2844588, , 18057
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Local Institution - 0081
Tübingen 2820860, , 72076
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Local Institution - 0026
Afula 295740, , 1834111
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Local Institution - 0054
Jerusalem 281184, , 9112001
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Local Institution - 0102
Petah-Tikvah, , 4941492
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Local Institution - 0173
Tel Aviv 293397, , 6423906
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Local Institution - 0035
Tel Litwinsky 293361, , 5262100
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Local Institution - 0051
Bari 3182351, , 70124
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Local Institution - 0077
Genova 8969657, , 16132
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Local Institution - 0170
Milan 3173435, , 20133
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Local Institution - 0084
Napoli 9031661, , 80131
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Local Institution - 0032
Perugia 3171180, , 06132
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Local Institution - 0064
Roma 8957247, , 00168
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Local Institution - 0014
Siena 3166548, , 53100
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Local Institution - 0163
Bodø 3160881, , 8005
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Local Institution - 0156
Grålum 9404106, , 1714
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Local Institution - 0158
Lørenskog, , 1474
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Address
Local Institution - 0155
Oslo 3143244, , 0379
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Local Institution - 0171
Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500, 85-796
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Address
Local Institution - 0021
Krakow 3094802, Lesser Poland Voivodeship 858786, 30727
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Address
Local Institution - 0005
Opole 3090048, Opole Voivodeship 3337495, 45-061
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Local Institution - 0015
Poznan 3088171, Wiekopolskie, 60-780
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Address
Local Institution - 0066
Warsaw 756135, , 02-781
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Local Institution - 0012
Donostia / San Sebastian 3110044, Gipuzkoa, 20014
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Local Institution - 0086
A Coruña 3119841, , 15006
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Local Institution - 0134
Badalona 3129028, , 08916
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Local Institution - 0047
Barcelona 3128760, , 08035
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Local Institution - 0024
Barcelona 3128760, , 08036
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Local Institution - 0153
Jaén 2516395, , 23007
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Local Institution - 0045
Las Palmas de Gran Canaria 2515270, , 35016
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Local Institution - 0040
Madrid 3117735, , 28007
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Local Institution - 0126
Madrid 3117735, , 28009
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Local Institution - 0004
Madrid 3117735, , 28041
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Local Institution - 0056
Madrid 3117735, , 28050
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Local Institution - 0006
Seville 2510911, , 41009
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Local Institution - 0041
Valencia 2509954, , 46009
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Address
Local Institution - 0043
Valencia 2509954, , 46009
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Address
Local Institution - 0151
Valencia 2509954, , 46014
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Address
Local Institution - 0062
Solna 2675397, Stockholm County 2673722, 171 64
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Local Institution - 0097
Lund 2693678, , 222 42
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Local Institution - 0092
Bern 2661552, , 3010
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Local Institution - 0080
Chur 2661169, , 7000
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Address
Local Institution - 0105
Lausanne 2659994, , 1011
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Address
Local Institution - 0088
London 2643743, Greater London, SW3 6JJ
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Local Institution - 0068
Headington, Oxford, Oxfordshire, OX3 7LE
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Address
Local Institution - 0120
Newcastle upon Tyne 2641673, Tyne and Wear, NE7 7DN
