New combo therapy aims to shrink head and neck tumors that resist standard treatment

NCT ID NCT06788990

Recruiting now Disease control Sponsor: Bicara Therapeutics Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 4 times

Summary

This study tests whether adding an experimental drug called ficerafusp alfa to the immunotherapy pembrolizumab (Keytruda) works better than pembrolizumab alone for people with PD-L1-positive head and neck cancer that has spread or returned. About 650 adults will be randomly assigned to receive either the combination or a placebo plus pembrolizumab. The goal is to see if the combo shrinks tumors and helps people live longer.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: ficerafusp alfa (BCA101) combined with pembrolizumab (Keytruda)
What this could lead to: If it works, this could offer a new first-line treatment option for people with advanced head and neck cancer that has spread or come back.
What could go wrong: This is an early-to-mid stage trial, so the combination may not prove more effective than current standard therapy. Side effects from adding a new drug to immunotherapy are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Camurati-Engelmann Syndrome Head and Neck Neoplasms head and neck squamous cell carcinoma laryngeal disorder metastatic squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

METASTATIC HEAD AND NECK SQUAMOUS CELL CARCINOMA RECURRENT HEAD AND NECK SQUAMOUS CELL CARCINOMA

Contacts and locations

Locations

Site # 0137
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Birmingham, Alabama, 35233, United States
Site # 0153
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Milwaukee, Wisconsin, 53233, United States
Site # 0159
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Seattle, Washington, 98104, United States
Site # 0160
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Edmonds, Washington, 98026, United States
Site # 0204
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Toronto, M4N 3M5, Canada
Site # 0501
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Sutton, SM2 5PT, United Kingdom
Site # 0510
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Glasgow, G12 0YN, United Kingdom
Site # 0514
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Portsmouth, PO6 3LY, United Kingdom
Site # 0603
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Cork, T12 DC4A, Ireland
Site # 0701
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Berlin, 12200, Germany
Site # 0702
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Ulm, 89075, Germany
Site # 0703
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Stuttgart, 70174, Germany
Site # 0705
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Chemnitz, 09116, Germany
Site # 0708
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Göttingen, 37075, Germany
Site # 0709
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Braunschweig, 38114, Germany
Site # 0711
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Dresden, 01307, Germany
Site # 0714
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Berlin, 12351, Germany
Site # 0715
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München, 81675, Germany
Site # 0716
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Essen, 45147, Germany
Site # 0718
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Hanover, 30625, Germany
Site # 0804
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Lille, 59000, France
Site # 0811
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Toulouse, 31059, France
Site # 0812
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Bordeaux, 33075, France
Site # 0813
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Paris, 75005, France
Site # 0902
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Siena, 53100, Italy
Site # 0903
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Pavia, 27100, Italy
Site # 0909
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Pisa, 56126, Italy
Site # 0910
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Padova, 35128, Italy
Site # 0912
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Milan, 20162, Italy
Site # 0916
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Naples, 80131, Italy
Site # 0919
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Rozzano, 20089, Italy
Site # 1201
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Ankara, 6100, Turkey (Türkiye)
Site # 1302
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Barcelona, 08908, Spain
Site # 1311
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Badalona, 8916, Spain
Site # 1405
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Gliwice, 44-102, Poland
Site # 1504
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Vila Nova de Gaia, 4434-502, Portugal
Site # 1701
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Athens, 12461, Greece
Site # 1702
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Larissa, 41110, Greece
Site # 1801
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Lausanne, 1011, Switzerland
Site # 1802
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Geneva, 1205, Switzerland
Site # 1803
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Fribourg, 1752, Switzerland
Site # 1902
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Tel Aviv, 6423906, Israel
Site # 1903
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Jerusalem, 9112001, Israel
Site # 2101
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Hradec Králové, 500 03, Czechia
Site # 2301
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Buenos Aires, C1190, Argentina
Site # 2302
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Santa Fe, S2002KDT, Argentina
Site # 2303
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Pilar, B1629ODT, Argentina
Site # 2305
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Rosario, CP2000, Argentina
Site # 2306
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Buenos Aires, C1425, Argentina
Site # 2401
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Santa Lúcia, 30360680, Brazil
Site # 2402
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Ijuí, 98700-000, Brazil
Site # 2404
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Curitiba, 80810-050, Brazil
Site # 2405
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São Paulo, 04014-002, Brazil
Site # 2406
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São José do Rio Preto, 15090-000, Brazil
Site # 2411
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Jaú, 17210-120, Brazil
Site # 2412
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Rio de Janeiro, 22250-905, Brazil
Site # 2413
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Barretos, 14784-400, Brazil
Site # 2415
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Santa Cruz do Sul, 96835-100, Brazil
Site # 2416
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São Paulo, 04543, Brazil
Site # 2419
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Passo Fundo, 99010-260, Brazil
Site # 2420
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Santa Cecília, Vitoria ES, 29043-260, Brazil
Site # 2422
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Natal, 59062-000, Brazil
Site # 2601
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Kaohsiung City, 807, Taiwan
Site # 2602
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Changhua, 50006, Taiwan
Site # 2603
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Taichung, 40447, Taiwan
Site # 2604
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Taipei, 10002, Taiwan
Site # 2701
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Seoul, 3080, South Korea
Site # 2702
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Seoul, 3722, South Korea
Site # 2704
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Goyang-si, 10408, South Korea
Site # 2705
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Hwasun, 58128, South Korea
Site # 2706
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Seongnam, 13620, South Korea
Site # 2707
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Busan, 49267, South Korea
Site # 2801
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Kuching, 93200, Malaysia
Site # 2802
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George Town, 11200, Malaysia
Site # 2803
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Kuala Lumpur, 50586, Malaysia
Site # 2804
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Pulau Pinang, 10450, Malaysia
Site # 2805
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Kuala Lumpur, 59100, Malaysia
Site # 2901
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Singapore, 168583, Singapore
Site # 2902
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Novena, 308433, Singapore
Site # 3002
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Sūrat, 395004, India
Site #0103
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Pittsburgh, Pennsylvania, 15206, United States
Site #0105
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Tampa, Florida, 33612, United States
Site #0106
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Los Angeles, California, 90095, United States
Site #0107
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La Jolla, California, 92093, United States
Site #0108
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Cleveland, Ohio, 44195, United States
Site #0112
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Baltimore, Maryland, 21201, United States
Site #0113
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Portland, Oregon, 97213, United States
Site #0114
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St Louis, Missouri, 63110, United States
Site #0116
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Nashville, Tennessee, 37232, United States
Site #0122
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Aurora, Colorado, 80012, United States
Site #0123
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Pittsburgh, Pennsylvania, 15240, United States
Site #0124
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Aurora, Colorado, 80045, United States
Site #0125
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Seattle, Washington, 98109, United States
Site #0129
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Richmond, Virginia, 23219, United States
Site #0130
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San Francisco, California, 94143, United States
Site #0131
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Boston, Massachusetts, 02114, United States
Site #0132
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Providence, Rhode Island, 02903, United States
Site #0136
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Palm Bay, Florida, 32901, United States
Site #0138
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Richmond, Virginia, 23249, United States
Site #0141
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Madison, Wisconsin, 53705, United States
Site #0145
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Newark, New Jersey, 07103, United States
Site #0146
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Rochester, Minnesota, 55905, United States
Site #0147
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Phoenix, Arizona, 85054, United States
Site #0148
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Jacksonville, Florida, 32224, United States
Site #0149
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Westwood, Kansas, 66205, United States
Site #0150
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Stanford, California, 94305, United States
Site #0151
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Cleveland, Ohio, 44106, United States
Site #0152
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Waco, Texas, 676712, United States
Site #0155
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New York, New York, 10003, United States
Site #0156
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Maplewood, Minnesota, 55109, United States
Site #0157
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Madison, Wisconsin, 53792, United States
Site #0202
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Vancouver, British Columbia, V5Z 4E6, Canada
Site #0203
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Montreal, Quebec, H2X 0C1, Canada
Site #0303
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Heidelberg, Victoria, 3084, Australia
Site #0305
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Southport, Queensland, 4215, Australia
Site #0306
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Kingswood, New South Wales, 2747, Australia
Site #0401
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Christchurch, 8011, New Zealand
Site #0502
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London, WC1E 6AG, United Kingdom
Site #0503
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Nottingham, NG5 1PB, United Kingdom
Site #0504
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Aberdeen, AB25 2ZN, United Kingdom
Site #0505
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London, SW3 6JJ, United Kingdom
Site #0506
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Middlesex, HA6 2RN, United Kingdom
Site #0507
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Liverpool, L7 8YA, United Kingdom
Site #0508
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Manchester, M20 4BX, United Kingdom
Site #0511
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Leeds, LS9 7TF, United Kingdom
Site #0512
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Birmingham, B15 2TH, United Kingdom
Site #0513
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Cambridge, CB2 0QQ, United Kingdom
Site #0515
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Oxford, OX3 7LE, United Kingdom
Site #0601
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Dublin, D09 V2N0, Ireland
Site #0602
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Dublin, D08 NHY1, Ireland
Site #0706
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Düsseldorf, 40225, Germany
Site #0707
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Dresden, 01067, Germany
Site #0710
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Aachen, 52074, Germany
Site #0717
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Karlsruhe, 76137, Germany
Site #0801
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Villejuif, 94805, France
Site #0805
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Rennes, 35042, France
Site #0806
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Vandœuvre-lès-Nancy, 54519, France
Site #0807
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Saint-Grégoire, 35760, France
Site #0808
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Strasbourg, 67200, France
Site #0809
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Amiens, 80480, France
Site #0810
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Lyon, 69004, France
Site #0901
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Milan, 20133, Italy
Site #0904
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Bologna, 40138, Italy
Site #0905
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Milan, 20142, Italy
Site #0906
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Rome, 00186, Italy
Site #0907
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Milan, 20132, Italy
Site #0908
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Palermo, 90127, Italy
Site #0911
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Florence, 50134, Italy
Site #0915
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Naples, 80131, Italy
Site #0917
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Rome, 00161, Italy
Site #0918
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Rome, 00168, Italy
Site #1001
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Sint-Niklaas, 9100, Belgium
Site #1002
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Namur, 5000, Belgium
Site #1003
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Namur, 5530, Belgium
Site #1005
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Mons, 7000, Belgium
Site #1006
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Wilrijk, 2610, Belgium
Site #1007
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Bruges, 8000, Belgium
Site #1301
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Barcelona, 08035, Spain
Site #1303
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Madrid, 28041, Spain
Site #1304
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Barcelona, 08041, Spain
Site #1305
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Barcelona, 08036, Spain
Site #1306
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Pamplona, 31008, Spain
Site #1307
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Valencia, 46010, Spain
Site #1308
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Valencia, 46014, Spain
Site #1309
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Santander, 39008, Spain
Site #1310
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Madrid, 28027, Spain
Site #1401
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Gdansk, 80-214, Poland
Site #1402
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Siedlce, 08-110, Poland
Site #1403
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Katowice, 40-519, Poland
Site #1404
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Krakow, 31-826, Poland
Site #1406
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Warsaw, 02-781, Poland
Site #1407
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Konin, 62-500, Poland
Site #1501
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Portimão, 8500-338, Portugal
Site #1502
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Senhora da Hora, 4464-509, Portugal
Site #1503
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Coimbra, Portugal
Site #1505
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Porto, 4200-072, Portugal
Site #1506
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Braga, 4710-243, Portugal
Site #1507
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Porto, 4200-319, Portugal
Site #1508
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Lisbon, 1099-023, Portugal
Site #1601
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Vienna, 1090, Austria
Site #1602
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Salzburg, 5020, Austria
Site #2102
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Prague, 15006, Czechia
Site#0101
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Boston, Massachusetts, 02136, United States
Site#0102
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Houston, Texas, 77005, United States
Site#0104
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Charleston, South Carolina, 29425, United States
Site#0111
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Louisville, Kentucky, 40202, United States
Site#0115
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Louisville, Kentucky, 40202, United States
Site#0117
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Cincinnati, Ohio, 45221, United States
Site#0118
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Durham, North Carolina, 27703, United States
Site#0120
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Vancouver, Washington, 98684, United States
Site#0121
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Aurora, Colorado, 80045, United States
Site#0126
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Nashville, Tennessee, 37203, United States
Site#0134
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Charlottesville, Virginia, 22904, United States
Site#0140
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Iowa City, Iowa, 52242, United States
Site#0142
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New York, New York, 10021, United States
Site#0144
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Sacramento, California, 95817, United States
Site#0154
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Canton, Ohio, 44708, United States
Site#0301
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North Melbourne, Victoria, 3051, Australia
Site#0302
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Camperdown, New South Wales, 2050, Australia
Site#0304
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Waratah, New South Wales, 2298, Australia
Site#0307
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Tugun, Queensland, 4224, Australia
Site#0308
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Murdoch, Western Australia, 6150, Australia
Site#0402
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Rotorua, 3010, New Zealand

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