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NCT03138512CompletedPhase 3

A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney

A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

Source: ClinicalTrials.gov · Last updated 18 Dec 2024

Brief summary (registry, in English)

The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1641 (actual)
First submitted
1 May 2017
Start date
7 Jul 2017
Primary completion date
28 Sept 2023
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT03138512
EudraCT number
2016-004502-34

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1641
  • From 7 Jul 2017 to the primary completion date, 28 Sept 2023
  • 200 sites in 25 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Participants with a condition requiring systemic treatment with corticosteroids
  • Participants who have received a live/attenuated vaccine within 30 days of first treatment
    • Other protocol-defined inclusion/exclusion criteria apply

Other illness

  • Participants with an active known or suspected autoimmune disease
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • History of allergy or hypersensitivity to study drug components

Lab values

  • Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation

Who the study is looking for

  • Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy
  • Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0
  • Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features
  • Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
  • Women must agree to follow methods of contraception, if applicable

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (200)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Local Institution - 0232
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BarilocheArgentinaUnknown status
Local Institution - 0179
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Buenos AiresArgentinaUnknown status
Local Institution - 0099
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CABAArgentinaUnknown status
Local Institution - 0178
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Capital FederalArgentinaUnknown status
Local Institution - 0126
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Ciudad Autonoma de Buenos AiresArgentinaUnknown status
Local Institution - 0203
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Ciudad Autónoma de Buenos AiresArgentinaUnknown status
Local Institution - 0098
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CórdobaArgentinaUnknown status
Local Institution - 0096
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CórdobaArgentinaUnknown status
Local Institution - 0208
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Mar del PlataArgentinaUnknown status
Local Institution - 0095
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Mar del PlataArgentinaUnknown status
Local Institution - 0173
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Río CuartoArgentinaUnknown status
Local Institution - 0164
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San JuanArgentinaUnknown status
Local Institution - 0097
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San Miguel de TucumánArgentinaUnknown status
Local Institution - 0068
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LinzAustriaUnknown status
Local Institution - 0084
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ViennaAustriaUnknown status
Local Institution - 0033
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ClaytonAustraliaUnknown status
Local Institution - 0034
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Elizabeth ValeAustraliaUnknown status
Local Institution - 0214
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HeidelbergAustraliaUnknown status
Local Institution - 0215
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Macquarie ParkAustraliaUnknown status
Local Institution - 0031
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MurdochAustraliaUnknown status
Local Institution - 0032
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NorthmeadAustraliaUnknown status
Local Institution - 0036
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RandwickAustraliaUnknown status
Local Institution - 0113
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South BrisbaneAustraliaUnknown status
Local Institution - 0213
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SouthportAustraliaUnknown status
Local Institution - 0035
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St LeonardsAustraliaUnknown status
Local Institution - 0064
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AnderlechtBelgiumUnknown status
Local Institution - 0058
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GhentBelgiumUnknown status
Local Institution - 0060
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HasseltBelgiumUnknown status
Local Institution - 0059
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LiègeBelgiumUnknown status
Local Institution - 0043
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BarretosBrazilUnknown status
Local Institution - 0045
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Belo HorizonteBrazilUnknown status
Local Institution - 0047
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BrasíliaBrazilUnknown status
Local Institution - 0046
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IjuíBrazilUnknown status
Local Institution - 0048
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Porto AlegreBrazilUnknown status
Local Institution - 0160
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Rio de JaneiroBrazilUnknown status
Local Institution - 0050
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São PauloBrazilUnknown status
Local Institution - 0044
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São PauloBrazilUnknown status
Local Institution - 0042
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MontrealCanadaUnknown status
Local Institution - 0087
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OshawaCanadaUnknown status
Local Institution - 0040
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RimouskiCanadaUnknown status
Local Institution - 0086
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Saint JohnCanadaUnknown status
Local Institution - 0112
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TorontoCanadaUnknown status
Local Institution - 0041
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VancouverCanadaUnknown status
Local Institution - 0218
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ChurSwitzerlandUnknown status
Local Institution - 0219
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Sankt GallenSwitzerlandUnknown status
Local Institution - 0225
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ZurichSwitzerlandUnknown status
Local Institution - 0223
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La SerenaChileUnknown status
Local Institution - 0221
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SantiagoChileUnknown status
Local Institution - 0246
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SantiagoChileUnknown status
Local Institution
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SantiagoChileUnknown status
Local Institution - 0222
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Viña del MarChileUnknown status
Local Institution - 0159
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BeijingChinaUnknown status
Local Institution - 0147
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BeijingChinaUnknown status
Local Institution - 0153
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BeijingChinaUnknown status
Local Institution - 0145
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ChangchunChinaUnknown status
Local Institution - 0143
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ChengduChinaUnknown status
Local Institution - 0142
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ChengduChinaUnknown status
Local Institution - 0132
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FuzhouChinaUnknown status
Local Institution - 0141
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GuangzhouChinaUnknown status
Local Institution - 0134
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GuangzhouChinaUnknown status
Local Institution - 0131
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HangzhouChinaUnknown status
Local Institution - 0157
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HangzhouChinaUnknown status
Local Institution - 0140
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NanchangChinaUnknown status
Local Institution - 0138
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NanjingChinaUnknown status
Local Institution - 0139
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NanjingChinaUnknown status
Local Institution - 0166
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ShanghaiChinaUnknown status
Local Institution - 0148
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ShanghaiChinaUnknown status
Local Institution - 0176
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ShanghaiChinaUnknown status
Local Institution - 0152
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ShanghaiChinaUnknown status
Local Institution - 0137
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ShanghaiChinaUnknown status
Local Institution - 0175
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TianjinChinaUnknown status
Local Institution - 0194
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WuhanChinaUnknown status
Local Institution - 0133
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WuhanChinaUnknown status
Local Institution - 0144
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Xi'anChinaUnknown status
Local Institution - 0146
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YantaiChinaUnknown status
Local Institution - 0229
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BogotáColombiaUnknown status
Local Institution - 0230
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FloridablancaColombiaUnknown status
Local Institution - 0227
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MedellínColombiaUnknown status
Local Institution - 0226
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PereiraColombiaUnknown status
Local Institution - 0228
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ValleduparColombiaUnknown status
Local Institution - 0094
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Hradec KrálovéCzechiaUnknown status
Local Institution - 0025
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OlomoucCzechiaUnknown status
Local Institution - 0053
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AachenGermanyUnknown status
Local Institution - 0103
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EssenGermanyUnknown status
Local Institution - 0052
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HamburgGermanyUnknown status
Local Institution - 0231
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HanoverGermanyUnknown status
Local Institution - 0061
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HanoverGermanyUnknown status
Local Institution - 0062
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JenaGermanyUnknown status
Local Institution - 0102
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MunichGermanyUnknown status
Local Institution - 0054
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NurembergGermanyUnknown status
Local Institution - 0055
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RostockGermanyUnknown status
Local Institution - 0217
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TübingenGermanyUnknown status
Local Institution - 0101
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WürzburgGermanyUnknown status
Local Institution - 0204
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BarcelonaSpainUnknown status
Local Institution - 0206
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BarcelonaSpainUnknown status
Local Institution - 0124
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CáceresSpainUnknown status
Local Institution - 0207
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CórdobaSpainUnknown status
Local Institution - 0118
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LugoSpainUnknown status
Local Institution - 0205
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MadridSpainUnknown status
Local Institution - 0114
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MadridSpainUnknown status
Local Institution - 0117
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SabadellSpainUnknown status
Local Institution - 0161
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SevilleSpainUnknown status
Local Institution - 0083
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BesançonFranceUnknown status
Local Institution - 0080
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BordeauxFranceUnknown status
Local Institution - 0082
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La Roche-sur-YonFranceUnknown status
Local Institution - 0116
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LyonFranceUnknown status
Local Institution - 0079
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MarseilleFranceUnknown status
Local Institution - 0198
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ParisFranceUnknown status
Local Institution - 0081
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RennesFranceUnknown status
Local Institution - 0077
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StrasbourgFranceUnknown status
Local Institution - 0115
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ToulouseFranceUnknown status
Local Institution - 0150
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ToursFranceUnknown status
Local Institution - 0078
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Vandœuvre-lès-NancyFranceUnknown status
Local Institution - 0076
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VillejuifFranceUnknown status
Local Institution - 0063
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ManchesterUnited KingdomUnknown status
Local Institution - 0071
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NorthwoodUnited KingdomUnknown status
Local Institution - 0073
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PrestonUnited KingdomUnknown status
Local Institution - 0075
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SouthamptonUnited KingdomUnknown status
Local Institution - 0072
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SwanseaUnited KingdomUnknown status
Local Institution - 0105
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ArezzoItalyUnknown status
Local Institution - 0172
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CremonaItalyUnknown status
Local Institution - 0106
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NaplesItalyUnknown status
Local Institution - 0107
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ParmaItalyUnknown status
Local Institution - 0109
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RomaItalyUnknown status
Local Institution - 0108
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VeronaItalyUnknown status
Local Institution - 0188
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Adachi-kuJapanUnknown status
Local Institution - 0119
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Bunkyo-kuJapanUnknown status
Local Institution - 0189
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Bunkyo-kuJapanUnknown status
Local Institution - 0158
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ChibaJapanUnknown status
Local Institution - 0121
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FukuokaJapanUnknown status
Local Institution - 0193
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Hirosaki-shiJapanUnknown status
Local Institution - 0165
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HiroshimaJapanUnknown status
Local Institution - 0130
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Kamigyō-kuJapanUnknown status
Local Institution - 0167
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KobeJapanUnknown status
Local Institution - 0216
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KumamotoJapanUnknown status
Local Institution - 0123
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NagasakiJapanUnknown status
Local Institution - 0120
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NiigataJapanUnknown status
Local Institution - 0125
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Osakasayama-shiJapanUnknown status
Local Institution - 0156
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SapporoJapanUnknown status
Local Institution - 0149
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Shinjuku-kuJapanUnknown status
Local Institution - 0168
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Shiwa-gunJapanUnknown status
Local Institution - 0122
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Suita-shiJapanUnknown status
Local Institution - 0162
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TokushimaJapanUnknown status
Local Institution - 0129
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Toyoake ShiJapanUnknown status
Local Institution - 0191
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TsukubaJapanUnknown status
Local Institution - 0163
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Ube-shiJapanUnknown status
Local Institution - 0192
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WakayamaJapanUnknown status
Local Institution - 0127
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YamagataJapanUnknown status
Local Institution - 0128
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YokohamaJapanUnknown status
Local Institution - 0089
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Chihuahua CityMexicoUnknown status
Local Institution - 0104
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MazatlánMexicoUnknown status
Local Institution - 0196
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MéridaMexicoUnknown status
Local Institution - 0151
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Mexico CityMexicoUnknown status
Local Institution - 0088
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Monterrey, NLMexicoUnknown status
Local Institution - 0169
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San Luis Potosí CityMexicoUnknown status
Local Institution - 0242
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TijuanaMexicoUnknown status
Local Institution - 0111
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TlalpanMexicoUnknown status
Local Institution - 0195
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TorreónMexicoUnknown status
Local Institution - 0197
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Tuxtla GutiérrezMexicoUnknown status
Local Institution - 0110
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ZapopanMexicoUnknown status
Local Institution - 0066
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AmsterdamNetherlandsUnknown status
Local Institution - 0067
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RotterdamNetherlandsUnknown status
Local Institution - 0092
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ZwolleNetherlandsUnknown status
Local Institution - 0155
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BydgoszczPolandUnknown status
Local Institution - 0038
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WroclawPolandUnknown status
Local Institution - 0243
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BucharestRomaniaUnknown status
Local Institution - 0200
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Cluj-NapocaRomaniaUnknown status
Local Institution - 0247
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Cluj-NapocaRomaniaUnknown status
Local Institution - 0199
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CraiovaRomaniaUnknown status
Local Institution - 0202
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IașiRomaniaUnknown status
Local Institution - 0065
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MoscowRussiaUnknown status
Local Institution - 0170
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NovosibirskRussiaUnknown status
Local Institution - 0021
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Saint PetersburgRussiaUnknown status
Local Institution - 0171
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Saint PetersburgRussiaUnknown status
Local Institution - 0018
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SingaporeSingaporeUnknown status
Local Institution - 0017
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SingaporeSingaporeUnknown status
Local Institution - 0010
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AllentownUnited StatesUnknown status
Local Institution - 0016
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AthensUnited StatesUnknown status
Local Institution - 0185
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AuroraUnited StatesUnknown status
Local Institution - 0019
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BirminghamUnited StatesUnknown status
Local Institution - 0007
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BuffaloUnited StatesUnknown status
Local Institution - 0013
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ChattanoogaUnited StatesUnknown status
Local Institution
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ChicagoUnited StatesUnknown status
Local Institution - 0005
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ChicagoUnited StatesUnknown status
Local Institution - 0008
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ColumbusUnited StatesUnknown status
Local Institution - 0057
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FairfaxUnited StatesUnknown status
Local Institution - 0014
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GreenvilleUnited StatesUnknown status
Local Institution - 0012
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Howell TownshipUnited StatesUnknown status
Local Institution - 0186
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Los AngelesUnited StatesUnknown status
Local Institution - 0180
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Los AngelesUnited StatesUnknown status
Local Institution - 0183
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NashvilleUnited StatesUnknown status
Local Institution - 0181
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New YorkUnited StatesUnknown status
Local Institution - 0001
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New YorkUnited StatesUnknown status
Local Institution - 0009
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PortlandUnited StatesUnknown status
Local Institution - 0002
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San FranciscoUnited StatesUnknown status
Local Institution - 0056
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SpringdaleUnited StatesUnknown status
Local Institution - 0006
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St LouisUnited StatesUnknown status
Local Institution - 0209
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AnkaraTurkey (Türkiye)Unknown status
Local Institution - 0210
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IstanbulTurkey (Türkiye)Unknown status
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IstanbulTurkey (Türkiye)Unknown status

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