A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy

Last updated: June 23, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Lung Cancer

Head And Neck Cancer

Carcinoma

Treatment

volrustomig

Clinical Study ID

NCT06129864
D798EC00001
  • Ages 18-130
  • All Genders

Study Summary

The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically documented locally advanced squamous cell carcinomaof the oropharynx, hypopharynx, oral cavity, or larynx with no evidence ofmetastatic disease (i.e. M0).

  • Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition ofthe American Joint Committee on Cancer (AJCC) staging manual (tumor, node,metastasis (TNM) staging system).

  • Participants will have completed definitive concurrent chemoradiotherapy (cCRT) withcurative intent prior to randomization.

Exclusion

Exclusion Criteria:

  • Histologically/cytologically confirmed head and neck cancer of any other primaryanatomic location in the head and neck not specified in the inclusion criteriaincluding participants with squamous cell carcinoma of unknown primary ornon-squamous histologies (eg, nasopharynx or salivary gland). Participants with >1primary tumors are not eligible for the study.

  • Participants with any of the following:

  1. LA-HNSCC that was resected before definitive cCRT

  2. LA-HNSCC that was treated and is recurrent at the time of screening

  • Participants who have received radiotherapy (RT) alone as definitive local therapyfor LA-HNSCC.

Study Design

Total Participants: 1145
Treatment Group(s): 1
Primary Treatment: volrustomig
Phase: 3
Study Start date:
December 14, 2023
Estimated Completion Date:
February 28, 2031

Connect with a study center

  • Research Site

    Graz, 8036
    Austria

    Active - Recruiting

  • Research Site

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • Research Site

    Linz, 4010
    Austria

    Active - Recruiting

  • Research Site

    Salzburg, 5020
    Austria

    Active - Recruiting

  • Research Site

    Vienna, 1080
    Austria

    Active - Recruiting

  • Research Site

    Charleroi, 6060
    Belgium

    Active - Recruiting

  • Research Site

    Edegem, 2650
    Belgium

    Active - Recruiting

  • Research Site

    Jette, 1090
    Belgium

    Active - Recruiting

  • Research Site

    La Louvière, 7100
    Belgium

    Active - Recruiting

  • Research Site

    Namur, 5000
    Belgium

    Active - Recruiting

  • Research Site

    Barretos, 14784-400
    Brazil

    Active - Recruiting

  • Research Site

    Florianópolis, 88034-000
    Brazil

    Active - Recruiting

  • Research Site

    Fortaleza, 60336-045
    Brazil

    Active - Recruiting

  • Research Site

    Ijuí, 98700-000
    Brazil

    Active - Recruiting

  • Research Site

    Ipatinga, 35162-189
    Brazil

    Active - Recruiting

  • Research Site

    Londrina, 86015-520
    Brazil

    Active - Recruiting

  • Research Site

    Natal, 59075-740
    Brazil

    Active - Recruiting

  • Research Site

    Porto Alegre, 91350200
    Brazil

    Active - Recruiting

  • Research Site

    Ribeirão Preto, 14051-140
    Brazil

    Suspended

  • Research Site

    Rio de Janeiro, 20231-050
    Brazil

    Suspended

  • Research Site

    Sao Paulo, 01509-900
    Brazil

    Active - Recruiting

  • Research Site

    São Paulo, 04538-132
    Brazil

    Active - Recruiting

  • Research Site

    São Paulo 3448439, 04538-132
    Brazil

    Active - Recruiting

  • Research Site

    Teresina, 64049-200
    Brazil

    Active - Recruiting

  • Research Site

    Calgary, Alberta T2N 5G2
    Canada

    Active - Recruiting

  • Research Site

    Edmonton, Alberta T6G 1Z2
    Canada

    Active - Recruiting

  • Research Site

    Kelowna, British Columbia V1Y 5L3
    Canada

    Active - Recruiting

  • Research Site

    Kingston, Ontario K7L 2V7
    Canada

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  • Research Site

    London, Ontario N6A 5W9
    Canada

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  • Research Site

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • Research Site

    Chicoutimi, Quebec G7H 5H6
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec H3T 1E2
    Canada

    Terminated

  • Research Site

    Montreal 6077243, Quebec 6115047 H2X 0C1
    Canada

    Completed

  • Research Site

    Regina, S4T 7T1
    Canada

    Site Not Available

  • Research Site

    Beijing, 100210
    China

    Active - Recruiting

  • Research Site

    Beijing 1816670, 100142
    China

    Active - Recruiting

  • Research Site

    Bengbu, 233004
    China

    Active - Recruiting

  • Research Site

    Changchun, 130000
    China

    Site Not Available

  • Research Site

    Changsha, 410013
    China

    Active - Recruiting

  • Research Site

    Changsha 1815577, 410013
    China

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  • Research Site

    Chengdu, 610000
    China

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  • Research Site

    Chengdu 1815286, 610072
    China

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  • Research Site

    Chongqing, 400016
    China

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  • Research Site

    Chongqing 1814906, 400016
    China

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  • Research Site

    Dongwan, 523058
    China

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  • Research Site

    Fuzhou, 350014
    China

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  • Research Site

    Guangzhou, 510060
    China

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  • Research Site

    Guangzhou 1809858, 510080
    China

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  • Research Site

    Guiyang, 550002
    China

    Active - Recruiting

  • Research Site

    Hangzhou, 310022
    China

    Active - Recruiting

  • Research Site

    Harbin, 150049
    China

    Active - Recruiting

  • Research Site

    Hefei, 230001
    China

    Active - Recruiting

  • Research Site

    Huizhou, 516001
    China

    Active - Recruiting

  • Research Site

    Jinan, 250117
    China

    Active - Recruiting

  • Research Site

    Kunming, 650118
    China

    Site Not Available

  • Research Site

    Lanzhou, 730000
    China

    Active - Recruiting

  • Research Site

    Nanchang, 330029
    China

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  • Research Site

    Nanning, 530021
    China

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  • Research Site

    Shanghai, 20032
    China

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  • Research Site

    Shenyang, 110004
    China

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  • Research Site

    Shijiazhuang, 050000
    China

    Active - Recruiting

  • Research Site

    Tianjin, 300060
    China

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  • Research Site

    Tianjin 1792947, 300060
    China

    Site Not Available

  • Research Site

    Wuhan, 430060
    China

    Active - Recruiting

  • Research Site

    Wuhan 1791247, 430030
    China

    Active - Recruiting

  • Research Site

    Wuxi, 214122
    China

    Site Not Available

  • Research Site

    Xi'an, 710061
    China

    Active - Recruiting

  • Research Site

    Xiamen, 361003
    China

    Site Not Available

  • Research Site

    Zhengzhou, 450008
    China

    Active - Recruiting

  • Research Site

    Zhuhai, 519000
    China

    Active - Recruiting

  • Research Site

    Ürümqi, 830000
    China

    Site Not Available

  • Research Site

    Avignon, 84918
    France

    Active - Recruiting

  • Research Site

    Bordeaux, 33075
    France

    Active - Recruiting

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    Le Mans, 72000
    France

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    Lyon, 69373
    France

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    Nice, 06100
    France

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    Saint-Herblain, 44805
    France

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    Toulouse, 31059
    France

    Active - Recruiting

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    Villejuif, 94805
    France

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    Berlin, 12200
    Germany

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    Erlangen, 91054
    Germany

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    Essen, 45122
    Germany

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    Freiburg im Breisgau, 79106
    Germany

    Site Not Available

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    Greifswald, 17475
    Germany

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    Hamburg, 20246
    Germany

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    Hanover, 30625
    Germany

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    Leipzig, 04103
    Germany

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    Lübeck, 23538
    Germany

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    München, 81675
    Germany

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    Rostock, 18059
    Germany

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  • Research Site

    Tübingen, 72076
    Germany

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  • Research Site

    Ulm, 89075
    Germany

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  • Research Site

    Würzburg, 97070
    Germany

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  • Research Site

    Budapest, 1145
    Hungary

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  • Research Site

    Budapest 3054643, 1122
    Hungary

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  • Research Site

    Gyula, 5700
    Hungary

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  • Research Site

    Győr, 9024
    Hungary

    Active - Recruiting

  • Research Site

    Kecskemét, 6000
    Hungary

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  • Research Site

    Miskolc, 3526
    Hungary

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  • Research Site

    Nyíregyháza, 4400
    Hungary

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  • Research Site

    Pécs, 7624
    Hungary

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  • Research Site

    Szekszárd, 7100
    Hungary

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  • Research Site

    Bengaluru, 560027
    India

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  • Research Site

    Hyderabad, 500032
    India

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  • Research Site

    Jaipur, 302022
    India

    Site Not Available

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    Kanpur, 208005
    India

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  • Research Site

    Kochi, 682027
    India

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  • Research Site

    Kolkata, 700099
    India

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  • Research Site

    Lucknow, 226003
    India

    Site Not Available

  • Research Site

    Madurai, 625107
    India

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  • Research Site

    Mohali, 160055
    India

    Site Not Available

  • Research Site

    Nashik, 422002
    India

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  • Research Site

    New Delhi, 110076
    India

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  • Research Site

    Thiruvananthapuram, 695011
    India

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  • Research Site

    Vadodara, 391760
    India

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  • Research Site

    Varanasi, 221005
    India

    Active - Recruiting

  • Research Site

    Aviano, 33081
    Italy

    Active - Recruiting

  • Research Site

    Florence, 50139
    Italy

    Active - Recruiting

  • Research Site

    Milan, 20133
    Italy

    Active - Recruiting

  • Research Site

    Modena, 41124
    Italy

    Active - Recruiting

  • Research Site

    Naples, 80131
    Italy

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  • Research Site

    Padova, 35128
    Italy

    Active - Recruiting

  • Research Site

    Pavia, 27100
    Italy

    Active - Recruiting

  • Research Site

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Research Site

    Bunkyo-ku, 113-8519
    Japan

    Active - Recruiting

  • Research Site

    Bunkyō City, 113-8431
    Japan

    Active - Recruiting

  • Research Site

    Bunkyō City 11790632, 113-8519
    Japan

    Active - Recruiting

  • Research Site

    Chiba, 260-8677
    Japan

    Active - Recruiting

  • Research Site

    Chiba 2113015, 260-0877
    Japan

    Active - Recruiting

  • Research Site

    Chiba-shi, 260-8717
    Japan

    Active - Recruiting

  • Research Site

    Chūōku, 104-0045
    Japan

    Active - Recruiting

  • Research Site

    Fukuoka, 811-1395
    Japan

    Active - Recruiting

  • Research Site

    Hidaka-shi, 350-1298
    Japan

    Active - Recruiting

  • Research Site

    Hiroshima, 734-8551
    Japan

    Active - Recruiting

  • Research Site

    Kashiwa, 277-8577
    Japan

    Active - Recruiting

  • Research Site

    Kobe, 650-0017
    Japan

    Active - Recruiting

  • Research Site

    Kyoto, 606-8507
    Japan

    Site Not Available

  • Research Site

    Kōtoku, 135-8550
    Japan

    Active - Recruiting

  • Research Site

    Nagoya, 466-8560
    Japan

    Active - Recruiting

  • Research Site

    Nagoya 1856057, 466-8560
    Japan

    Active - Recruiting

  • Research Site

    Nagoya-shi, 464-8681
    Japan

    Active - Recruiting

  • Research Site

    Niigata, 951-8520
    Japan

    Active - Recruiting

  • Research Site

    Okayama, 700-8558
    Japan

    Active - Recruiting

  • Research Site

    Osaka, 541-8567
    Japan

    Active - Recruiting

  • Research Site

    Osakasayama-shi, 589-8511
    Japan

    Active - Recruiting

  • Research Site

    Sagamihara-shi, 252-0375
    Japan

    Active - Recruiting

  • Research Site

    Sapporo, 060-8638
    Japan

    Active - Recruiting

  • Research Site

    Sendai, 980-8574
    Japan

    Active - Recruiting

  • Research Site

    Shinjuku-ku, 160-0023
    Japan

    Active - Recruiting

  • Research Site

    Shiwa-gun, 028-3695
    Japan

    Active - Recruiting

  • Research Site

    Sunto-gun, 411-8777
    Japan

    Active - Recruiting

  • Research Site

    Yokohama, 236-0004
    Japan

    Active - Recruiting

  • Research Site

    Yokohama 1848354, 241-8515
    Japan

    Active - Recruiting

  • Research Site

    Yokohama-shi, 236-0004
    Japan

    Active - Recruiting

  • Research Site

    Seoul, 5505
    Korea, Republic of

    Active - Recruiting

  • Research Site

    George Town, 10450
    Malaysia

    Active - Recruiting

  • Research Site

    Johor Bahru, 81100
    Malaysia

    Active - Recruiting

  • Research Site

    Kuala Lumpur, 59100
    Malaysia

    Active - Recruiting

  • Research Site

    Kuala Lumpur 1735161, 59100
    Malaysia

    Active - Recruiting

  • Research Site

    Kuala Selangor, 62250
    Malaysia

    Active - Recruiting

  • Research Site

    Kuching, 93586
    Malaysia

    Active - Recruiting

  • Research Site

    Cebu City, 6000
    Philippines

    Site Not Available

  • Research Site

    General Santos, 9500
    Philippines

    Site Not Available

  • Research Site

    Iloilo City, 5000
    Philippines

    Site Not Available

  • Research Site

    Manila, 1008
    Philippines

    Site Not Available

  • Research Site

    Pasig, 1605
    Philippines

    Site Not Available

  • Research Site

    Quezon City, 1112
    Philippines

    Site Not Available

  • Research Site

    West San Juan City, 1502
    Philippines

    Site Not Available

  • Research Site

    Bialystok, 15-027
    Poland

    Active - Recruiting

  • Research Site

    Bielsko-Biala, 43-300
    Poland

    Active - Recruiting

  • Research Site

    Bydgoszcz, 85-796
    Poland

    Active - Recruiting

  • Research Site

    Gliwice, 44-102
    Poland

    Active - Recruiting

  • Research Site

    Olsztyn, 10-228
    Poland

    Active - Recruiting

  • Research Site

    Piotrkow Trybunalski, 97-300
    Poland

    Active - Recruiting

  • Research Site

    Siedlce, 08-110
    Poland

    Active - Recruiting

  • Research Site

    Tomaszów Mazowiecki, 97-200
    Poland

    Site Not Available

  • Research Site

    Warsaw, 02-781
    Poland

    Active - Recruiting

  • Research Site

    San Juan, 00927
    Puerto Rico

    Completed

  • Research Site

    Goyang-si, 410-769
    South Korea

    Active - Recruiting

  • Research Site

    Gyeonggi-do, 13620
    South Korea

    Active - Recruiting

  • Research Site

    Incheon, 21565
    South Korea

    Active - Recruiting

  • Research Site

    Seoul, 06351
    South Korea

    Active - Recruiting

  • Research Site

    Seoul 1835848, 3722
    South Korea

    Active - Recruiting

  • Research Site

    Suwon, 16247
    South Korea

    Active - Recruiting

  • Research Site

    Badalona, 08916
    Spain

    Active - Recruiting

  • Research Site

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Research Site

    Barcelona 3128760, 08036
    Spain

    Active - Recruiting

  • Research Site

    Jaén, 23007
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28034
    Spain

    Active - Recruiting

  • Research Site

    Madrid 3117735, 28007
    Spain

    Active - Recruiting

  • Research Site

    Valencia, 46026
    Spain

    Active - Recruiting

  • Research Site

    Valencia 2509954, 46014
    Spain

    Active - Recruiting

  • Research Site

    Changhua, 500
    Taiwan

    Active - Recruiting

  • Research Site

    Kaohsiung, 80756
    Taiwan

    Site Not Available

  • Research Site

    Kaohsiung City, 80756
    Taiwan

    Active - Recruiting

  • Research Site

    Kaohsiung City 1673820, 80756
    Taiwan

    Active - Recruiting

  • Research Site

    Taichung, 404
    Taiwan

    Active - Recruiting

  • Research Site

    Taichung 1668399, 40705
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei 1668341, 11217
    Taiwan

    Active - Recruiting

  • Research Site

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Research Site

    Bangkok, 10400
    Thailand

    Active - Recruiting

  • Research Site

    Bangkok 1609350, 10300
    Thailand

    Active - Recruiting

  • Research Site

    Chaing Mai, 50200
    Thailand

    Active - Recruiting

  • Research Site

    Hat Yai, 90110
    Thailand

    Active - Recruiting

  • Research Site

    Khon Kaen, 40002
    Thailand

    Site Not Available

  • Research Site

    Lampang, 52000
    Thailand

    Active - Recruiting

  • Research Site

    Muang, 22000
    Thailand

    Active - Recruiting

  • Research Site

    Mueang, 20000
    Thailand

    Active - Recruiting

  • Research Site

    Ankara, 06230
    Turkey

    Active - Recruiting

  • Research Site

    Ankara, 06230
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Ankara 323786, 6200
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Antalya, 07059
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Cordaleo, 35575
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Eskişehir, 26040
    Turkey (Türkiye)

    Active - Recruiting

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    Istanbul, 34722
    Turkey (Türkiye)

    Site Not Available

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    Yenimahalle, 06170
    Turkey (Türkiye)

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    Aberdeen, AB25 2ZN
    United Kingdom

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    Cambridge, CB2 0XY
    United Kingdom

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    Hampshire, SO16 6YD
    United Kingdom

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    Leeds, LS9 7TF
    United Kingdom

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    London, SW3 6JJ
    United Kingdom

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    London 2643743, SW3 6JJ
    United Kingdom

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    Manchester, M20 4BX
    United Kingdom

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    Metropolitan Borough of Wirral, CH63 4JY
    United Kingdom

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    Northwood, HA6 2RN
    United Kingdom

    Active - Recruiting

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    Sutton, SM2 5PT
    United Kingdom

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    Taunton, TA1 5DA
    United Kingdom

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    Birmingham, Alabama 35233
    United States

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    Phoenix, Arizona 85028
    United States

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    Prescott Valley, Arizona 86314
    United States

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    Springdale, Arkansas 72762
    United States

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    Fountain Valley, California 92708
    United States

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    Los Angeles, California 90024
    United States

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    Orange, California 92868
    United States

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    San Francisco, California 94143
    United States

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    Santa Rosa, California 95403
    United States

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    Whittier, California 90602
    United States

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    Aurora, Colorado 80045
    United States

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    Colorado Springs, Colorado 80909
    United States

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    Lone Tree, Colorado 80124
    United States

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    Washington D.C., District of Columbia 20037
    United States

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    Fort Myers, Florida 33901
    United States

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    Gainesville, Florida 32610
    United States

    Site Not Available

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    Miami, Florida 33125
    United States

    Site Not Available

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    Palm Bay, Florida 32909
    United States

    Active - Recruiting

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    West Palm Beach, Florida 33401
    United States

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    Niles, Illinois 60714
    United States

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    Des Moines, Iowa 50309
    United States

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  • Research Site

    Kansas City, Kansas 66160
    United States

    Completed

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    Louisville, Kentucky 40202
    United States

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    Baton Rouge, Louisiana 70817
    United States

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    Shreveport, Louisiana 71101
    United States

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    Baltimore, Maryland 21231
    United States

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    Bethesda, Maryland 20817
    United States

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    Hyattsville, Maryland 20782
    United States

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    Towson, Maryland 21204
    United States

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    Upper Marlboro, Maryland 20774
    United States

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    Boston, Massachusetts 02215
    United States

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    Fairhaven, Massachusetts 02719
    United States

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    Ann Arbor, Michigan 48105
    United States

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    Ann Arbor 4984247, Michigan 5001836 48105
    United States

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    Minneapolis, Minnesota 55417
    United States

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  • Research Site

    Columbia, Missouri 65211
    United States

    Site Not Available

  • Research Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    St Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Research Site

    East Brunswick, New Jersey 08816
    United States

    Site Not Available

  • Research Site

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Research Site

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Research Site

    Albuquerque, New Mexico 87108
    United States

    Active - Recruiting

  • Research Site

    New York, New York 10075
    United States

    Active - Recruiting

  • Research Site

    Stony Brook, New York 11794
    United States

    Active - Recruiting

  • Research Site

    New York 5128581, New York 5128638 10075
    United States

    Active - Recruiting

  • Research Site

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Research Site

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Research Site

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Research Site

    Portland, Oregon 97213
    United States

    Site Not Available

  • Research Site

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

  • Research Site

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Research Site

    Pittsburgh, Pennsylvania 15261
    United States

    Active - Recruiting

  • Research Site

    York, Pennsylvania 17403
    United States

    Active - Recruiting

  • Research Site

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • Research Site

    Sioux Falls 5231851, South Dakota 5769223 57104
    United States

    Active - Recruiting

  • Research Site

    Nashville, Tennessee 37212
    United States

    Active - Recruiting

  • Research Site

    Austin, Texas 78745
    United States

    Active - Recruiting

  • Research Site

    Dallas, Texas 75251
    United States

    Active - Recruiting

  • Research Site

    Flower Mound, Texas 75028
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    Odessa, Texas 79761
    United States

    Active - Recruiting

  • Research Site

    Tyler, Texas 75702
    United States

    Site Not Available

  • Research Site

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Research Site

    West Jordan, Utah 84088
    United States

    Active - Recruiting

  • Research Site

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Research Site

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Research Site

    Richmond, Virginia 23230
    United States

    Site Not Available

  • Research Site

    Spokane, Washington 99204
    United States

    Site Not Available

  • Research Site

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Research Site

    Tacoma 5812944, Washington 5815135 98415
    United States

    Active - Recruiting

  • Research Site

    Da Nang, 550000
    Vietnam

    Active - Recruiting

  • Research Site

    Hanoi, 100000
    Vietnam

    Active - Recruiting

  • Research Site

    Ho Chi Minh City, 700000
    Vietnam

    Active - Recruiting

  • Research Site

    Huế, 530000
    Vietnam

    Active - Recruiting

  • Research Site

    Hà Nội, 100000
    Vietnam

    Active - Recruiting

  • Research Site

    Vinh, 460000
    Vietnam

    Active - Recruiting

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