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

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

More Inclusion & Exclusion Criteria

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 who are ≥ 12 years of age and < 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent).

- Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).

Exclusion Criteria.

- 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.

Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.

- Other protocol-defined Inclusion/Exclusion criteria apply.

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.	NCT05625399
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 & Interventions

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.

Local Institution - 0125, Phoenix, Arizona

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Address

Local Institution - 0125

Phoenix, Arizona, 85013

Local Institution - 0189, Springdale, Arkansas

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Address

Local Institution - 0189

Springdale, Arkansas, 72762

Local Institution - 0098, Los Angeles, California

Status

Address

Local Institution - 0098

Los Angeles, California, 90025

Local Institution - 0093, Orange, California

Status

Address

Local Institution - 0093

Orange, California, 92868-3201

Local Institution - 0123, Stanford, California

Status

Address

Local Institution - 0123

Stanford, California, 94305

Local Institution - 0113, Englewood, Colorado

Status

Address

Local Institution - 0113

Englewood, Colorado, 80113

Local Institution - 0114, Jacksonville, Florida

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Address

Local Institution - 0114

Jacksonville, Florida, 32224

Local Institution - 0146, Baltimore, Maryland

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Address

Local Institution - 0146

Baltimore, Maryland, 21201

Local Institution - 0071, Rochester, Minnesota

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Address

Local Institution - 0071

Rochester, Minnesota, 55905

Local Institution - 0013, Omaha, Nebraska

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Address

Local Institution - 0013

Omaha, Nebraska, 68130

Local Institution - 0169, Cleveland, Ohio

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Address

Local Institution - 0169

Cleveland, Ohio, 44195

Local Institution - 0139, Easton, Pennsylvania

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Address

Local Institution - 0139

Easton, Pennsylvania, 18045

Local Institution - 0124, Philadelphia, Pennsylvania

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Address

Local Institution - 0124

Philadelphia, Pennsylvania, 19107

Local Institution - 0122, Murray, Utah

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Address

Local Institution - 0122

Murray, Utah, 84107

Local Institution - 0115, Fairfax, Virginia

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Address

Local Institution - 0115

Fairfax, Virginia, 22031

International Sites

Local Institution - 0050, Coffs Harbour, New South Wales, Australia

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Address

Local Institution - 0050

Coffs Harbour, New South Wales, 2450

Local Institution - 0175, Orange, New South Wales, Australia

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Address

Local Institution - 0175

Orange, New South Wales, 2800

Local Institution - 0172, Port Macquarie, New South Wales, Australia

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Address

Local Institution - 0172

Port Macquarie, New South Wales, 2444

Local Institution - 0118, Wagga Wagga, New South Wales, Australia

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Address

Local Institution - 0118

Wagga Wagga, New South Wales, 2650

Local Institution - 0184, Waratah, New South Wales, Australia

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Address

Local Institution - 0184

Waratah, New South Wales, 2298

Local Institution - 0033, Westmead, New South Wales, Australia

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Address

Local Institution - 0033

Westmead, New South Wales, 2145

Local Institution - 0055, Wollstonecraft, New South Wales, Australia

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Address

Local Institution - 0055

Wollstonecraft, New South Wales, 2065

Local Institution - 0090, Birtinya, Queensland, Australia

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Address

Local Institution - 0090

Birtinya, Queensland, 4575

Local Institution - 0008, Bendigo, Victoria, Australia

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Address

Local Institution - 0008

Bendigo, Victoria, 3550

Local Institution - 0059, Box Hill, Victoria, Australia

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Address

Local Institution - 0059

Box Hill, Victoria, 3128

Local Institution - 0154, Heidelberg, Victoria, Australia

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Address

Local Institution - 0154

Heidelberg, Victoria, 3084

Local Institution - 0030, Melbourne, Victoria, Australia

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Address

Local Institution - 0030

Melbourne, Victoria, 3004

Local Institution - 0109, Traralgon, Victoria, Australia

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Local Institution - 0109

Traralgon, Victoria, 3844

Local Institution - 0106, Nedlands, Western Australia, Australia

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Local Institution - 0106

Nedlands, Western Australia, 6009

Local Institution - 0161, Nedlands, Western Australia, Australia

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Address

Local Institution - 0161

Nedlands, Western Australia, 6009

Local Institution - 0027, Graz, Austria

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Local Institution - 0027

Graz, , 8036

Local Institution - 0029, Salzburg, Austria

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Local Institution - 0029

Salzburg, , 5020

Local Institution - 0168, St. Polten, Austria

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Address

Local Institution - 0168

St. Polten, , 3100

Local Institution - 0037, Wien, Austria

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Address

Local Institution - 0037

Wien, , 1090

Local Institution - 0072, Brussels, Belgium

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Local Institution - 0072

Brussels, , 1200

Local Institution - 0078, Charleroi, Belgium

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Local Institution - 0078

Charleroi, , 6000

Local Institution - 0016, Liege, Belgium

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Address

Local Institution - 0016

Liege, , 4000

Local Institution - 0177, Fortaleza, Ce, Brazil

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Address

Local Institution - 0177

Fortaleza, Ce, 60135237

Local Institution - 0180, Vitoria, ES, Brazil

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Local Institution - 0180

Vitoria, ES, 29043-260

Local Institution - 0107, Belo Horizonte, Minas Gerais, Brazil

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Local Institution - 0107

Belo Horizonte, Minas Gerais, 30130-090

Local Institution - 0025, Ijui, Rio Grande Do Sul, Brazil

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Local Institution - 0025

Ijui, Rio Grande Do Sul, 98700-000

Local Institution - 0002, Porto Alegrelegre, RIO Grande DO SUL, Brazil

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Local Institution - 0002

Porto Alegrelegre, RIO Grande DO SUL, 91350-250

Local Institution - 0031, Porto Alegre, RIO Grande DO SUL, Brazil

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Local Institution - 0031

Porto Alegre, RIO Grande DO SUL, 90035-903

Local Institution - 0058, Porto Alegre, Rio Grande Do Sul, Brazil

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Local Institution - 0058

Porto Alegre, Rio Grande Do Sul, 90610-000

Local Institution - 0009, Barretos, Sao Paulo, Brazil

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Local Institution - 0009

Barretos, Sao Paulo, 14784-400

Local Institution - 0018, Sao Jose do Rio Preto, Sao Paulo, Brazil

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Local Institution - 0018

Sao Jose do Rio Preto, Sao Paulo, 15090-000

Local Institution - 0159, Blumenau, SC, Brazil

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Local Institution - 0159

Blumenau, SC, 89010-340

Local Institution - 0110, Rio De Janeiro, Brazil

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Address

Local Institution - 0110

Rio De Janeiro, , 20220-410

Local Institution - 0130, Sao Paulo, Brazil

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Local Institution - 0130

Sao Paulo, , 01321-001

Local Institution - 0141, Calgary, Alberta, Canada

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Local Institution - 0141

Calgary, Alberta, T2N 5G2

Local Institution - 0121, Hamilton, Ontario, Canada

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Local Institution - 0121

Hamilton, Ontario, L8V 5C2

Local Institution - 0096, Ottawa, Ontario, Canada

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Local Institution - 0096

Ottawa, Ontario, K1H 8L6

Local Institution - 0116, Toronto, Ontario, Canada

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Local Institution - 0116

Toronto, Ontario, M4N 3M5

Local Institution - 0103, Quebec, Canada

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Local Institution - 0103

Quebec, , G1J 1Z4

Local Institution - 0143, Temuco, Araucania, Chile

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Local Institution - 0143

Temuco, Araucania, 4800827

Local Institution - 0178, Puerto Montt, Los Lagos, Chile

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Local Institution - 0178

Puerto Montt, Los Lagos, 5507642

Local Institution - 0140, Recoleta, Metropolitana, Chile

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Local Institution - 0140

Recoleta, Metropolitana, 8380455

Local Institution - 0144, Santiago, Metropolitana, Chile

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Local Institution - 0144

Santiago, Metropolitana, 0101010

Local Institution - 0010, Santiago, Metropolitana, Chile

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Local Institution - 0010

Santiago, Metropolitana, 7510032

Local Institution - 0074, Santiago, Metropolitana, Chile

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Address

Local Institution - 0074

Santiago, Metropolitana, 8150513

Local Institution - 0119, Santiago de Chile, Providencia, Chile

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Address

Local Institution - 0119

Santiago de Chile, Providencia, 7500653

Local Institution - 0028, Vina Del Mar, Valparaiso, Chile

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Local Institution - 0028

Vina Del Mar, Valparaiso, 2520598

Local Institution - 0017, Santiago, Chile

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Local Institution - 0017

Santiago, , 7500921

Local Institution - 0083, Prague, NY, Czechia

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Local Institution - 0083

Prague, NY, 128 00

Local Institution - 0094, Hradec Kralove, Czechia

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Local Institution - 0094

Hradec Kralove, , 500 05

Local Institution - 0091, Olomouc, Czechia

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Local Institution - 0091

Olomouc, , 77900

Local Institution - 0082, Ostrava Poruba, Czechia

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Local Institution - 0082

Ostrava Poruba, , 708 52

Local Institution - 0095, Prague, Czechia

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Local Institution - 0095

Prague, , 182 00

Local Institution - 0164, Helsinki, Finland

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Local Institution - 0164

Helsinki, , 00029

Local Institution - 0167, Tampere, Finland

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Local Institution - 0167

Tampere, , 33521

Local Institution - 0162, Turku, Finland

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Local Institution - 0162

Turku, , 20520

Local Institution - 0108, Toulouse, Cedex 9, France

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Local Institution - 0108

Toulouse, Cedex 9, 31059

Local Institution - 0034, Paris, Ile De France, France

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Local Institution - 0034

Paris, Ile De France, 75475

Local Institution - 0127, Chambray-les-Tours, Indre-Et-Loire, France

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Local Institution - 0127

Chambray-les-Tours, Indre-Et-Loire, 37044

Local Institution - 0111, Lille, Nord, France

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Local Institution - 0111

Lille, Nord, 59000

Local Institution - 0063, Nantes Cedex 01, OH, France

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Local Institution - 0063

Nantes Cedex 01, OH, 44093

Local Institution - 0061, Villejuif Cedex, Val-De-Marne, France

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Local Institution - 0061

Villejuif Cedex, Val-De-Marne, 94805

Local Institution - 0007, Amiens, France

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Local Institution - 0007

Amiens, , 80054

Local Institution - 0128, Bayonne, France

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Address

Local Institution - 0128

Bayonne, , 64100

Local Institution - 0022, Bordeaux, France

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Local Institution - 0022

Bordeaux, , 33000

Local Institution - 0129, Clermont Ferrand Cedex 1, France

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Address

Local Institution - 0129

Clermont Ferrand Cedex 1, , 63003

Local Institution - 0046, Dijon, France

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Address

Local Institution - 0046

Dijon, , 21079

Local Institution - 0117, Marseille, France

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Address

Local Institution - 0117

Marseille, , 13385

Local Institution - 0052, Pierre-Benite, France

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Address

Local Institution - 0052

Pierre-Benite, , 69310

Local Institution - 0089, Rennes Cedex, France

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Address

Local Institution - 0089

Rennes Cedex, , 35042

Local Institution - 0099, Rouen, France

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Local Institution - 0099

Rouen, , 76031

Local Institution - 0101, Heidelberg, Baden-Wurttemberg, Germany

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Address

Local Institution - 0101

Heidelberg, Baden-Wurttemberg, 69120

Local Institution - 0079, Ulm, Baden-Wurttemberg, Germany

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Local Institution - 0079

Ulm, Baden-Wurttemberg, 89081

Local Institution - 0011, Regensburg, Bayern, Germany

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Local Institution - 0011

Regensburg, Bayern, 93042

Local Institution - 0003, Luebeck, Schleswig-Holstein, Germany

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Local Institution - 0003

Luebeck, Schleswig-Holstein, 23538

Local Institution - 0060, Berlin, Germany

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Local Institution - 0060

Berlin, , 10117

Local Institution - 0038, Buxtehude, Germany

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Local Institution - 0038

Buxtehude, , 21614

Local Institution - 0136, Dortmund, Germany

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Local Institution - 0136

Dortmund, , 44137

Local Institution - 0039, Erfurt, Germany

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Local Institution - 0039

Erfurt, , 99089

Local Institution - 0049, Essen, Germany

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Address

Local Institution - 0049

Essen, , 45147

Local Institution - 0166, Frankfurt am Main, Germany

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Address

Local Institution - 0166

Frankfurt am Main, , 60590

Local Institution - 0065, Giessen, Germany

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Address

Local Institution - 0065

Giessen, , 35385

Local Institution - 0135, Goettingen, Germany

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Local Institution - 0135

Goettingen, , 37075

Local Institution - 0138, Hamburg, Germany

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Address

Local Institution - 0138

Hamburg, , 20251

Local Institution - 0137, Ludwigshafen, Germany

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Address

Local Institution - 0137

Ludwigshafen, , 67063

Local Institution - 0165, Marburg, Germany

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Address

Local Institution - 0165

Marburg, , 35043

Local Institution - 0044, Minden, Germany

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Address

Local Institution - 0044

Minden, , 32429

Local Institution - 0112, Nuernberg, Germany

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Address

Local Institution - 0112

Nuernberg, , 90419

Local Institution - 0053, Rostock, Germany

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Address

Local Institution - 0053

Rostock, , 18057

Local Institution - 0081, Tuebingen, Germany

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Address

Local Institution - 0081

Tuebingen, , 72076

Local Institution - 0026, Afula, Israel

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Address

Local Institution - 0026

Afula, , 1834111

Local Institution - 0054, Jerusalem, Israel

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Address

Local Institution - 0054

Jerusalem, , 9112001

Local Institution - 0102, Petah-Tikvah, Israel

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Address

Local Institution - 0102

Petah-Tikvah, , 4941492

Local Institution - 0035, Tel Hashomer, Israel

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Address

Local Institution - 0035

Tel Hashomer, , 5262100

Local Institution - 0173, Tel-Aviv, Israel

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Address

Local Institution - 0173

Tel-Aviv, , 6423906

Local Institution - 0051, Bari, Italy

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Address

Local Institution - 0051

Bari, , 70124

Local Institution - 0077, Genova, Italy

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Local Institution - 0077

Genova, , 16132

Local Institution - 0170, Milan, Italy

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Local Institution - 0170

Milan, , 20133

Local Institution - 0084, Napoli, Italy

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Local Institution - 0084

Napoli, , 80131

Local Institution - 0032, Perugia, Italy

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Local Institution - 0032

Perugia, , 06132

Local Institution - 0064, Roma, Italy

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Address

Local Institution - 0064

Roma, , 00168

Local Institution - 0014, Siena, Italy

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Address

Local Institution - 0014

Siena, , 53100

Local Institution - 0163, Bodo, Norway

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Address

Local Institution - 0163

Bodo, , 8005

Local Institution - 0156, Gralum, Norway

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Local Institution - 0156

Gralum, , 1714

Local Institution - 0158, Lørenskog, Norway

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Address

Local Institution - 0158

Lørenskog, , 1474

Local Institution - 0155, Oslo, Norway

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Address

Local Institution - 0155

Oslo, , 0379

Local Institution - 0171, Bydgoszcz, Kujawsko-pomorskie, Poland

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Address

Local Institution - 0171

Bydgoszcz, Kujawsko-pomorskie, 85-796

Local Institution - 0021, Krakow, Malopolskie, Poland

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Address

Local Institution - 0021

Krakow, Malopolskie, 30727

Local Institution - 0005, Opole, Opolskie, Poland

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Address

Local Institution - 0005

Opole, Opolskie, 45-061

Local Institution - 0015, Poznan, Wiekopolskie, Poland

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Address

Local Institution - 0015

Poznan, Wiekopolskie, 60-780

Local Institution - 0066, Warszawa, Poland

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Address

Local Institution - 0066

Warszawa, , 02-781

Local Institution - 0012, Donostia, Gipuzkoa, Spain

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Address

Local Institution - 0012

Donostia, Gipuzkoa, 20014

Local Institution - 0086, A Coruna, Spain

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Address

Local Institution - 0086

A Coruna, , 15006

Local Institution - 0134, Badalona, Spain

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Address

Local Institution - 0134

Badalona, , 08916

Local Institution - 0047, Barcelona, Spain

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Address

Local Institution - 0047

Barcelona, , 08035

Local Institution - 0024, Barcelona, Spain

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Address

Local Institution - 0024

Barcelona, , 08036

Local Institution - 0153, Jaen, Spain

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Address

Local Institution - 0153

Jaen, , 23007

Local Institution - 0045, Las Palmas de Gran Canaria, Spain

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Address

Local Institution - 0045

Las Palmas de Gran Canaria, , 35016

Local Institution - 0040, Madrid, Spain

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Local Institution - 0040

Madrid, , 28007

Local Institution - 0126, Madrid, Spain

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Address

Local Institution - 0126

Madrid, , 28009

Local Institution - 0004, Madrid, Spain

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Address

Local Institution - 0004

Madrid, , 28041

Local Institution - 0056, Madrid, Spain

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Address

Local Institution - 0056

Madrid, , 28050

Local Institution - 0006, Sevilla, Spain

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Address

Local Institution - 0006

Sevilla, , 41009

Local Institution - 0041, Valencia, Spain

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Address

Local Institution - 0041

Valencia, , 46009

Local Institution - 0043, Valencia, Spain

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Address

Local Institution - 0043

Valencia, , 46009

Local Institution - 0151, Valencia, Spain

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Address

Local Institution - 0151

Valencia, , 46014

Local Institution - 0062, Solna, Stockholm, Sweden

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Address

Local Institution - 0062

Solna, Stockholm, 171 64

Local Institution - 0097, Lund, Sweden

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Address

Local Institution - 0097

Lund, , 222 42

Local Institution - 0092, Bern, Switzerland

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Address

Local Institution - 0092

Bern, , 3010

Local Institution - 0080, Chur, Switzerland

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Address

Local Institution - 0080

Chur, , 7000

Local Institution - 0105, Lausanne, Switzerland

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Address

Local Institution - 0105

Lausanne, , 1011

Local Institution - 0088, London, Greater London, United Kingdom

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Address

Local Institution - 0088

London, Greater London, SW3 6JJ

Local Institution - 0068, Headington, Oxford, Oxfordshire, United Kingdom

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Address

Local Institution - 0068

Headington, Oxford, Oxfordshire, OX3 7LE

Local Institution - 0120, Newcastle Upon Tyne, Tyne And Wear, United Kingdom

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Address

Local Institution - 0120

Newcastle Upon Tyne, Tyne And Wear, NE7 7DN

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