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

Last updated: October 2, 2024
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Head And Neck Cancer

Carcinoma

Lung Cancer

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 within 12 weeks 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. Residual disease that needs further treatment with curative intent afterdefinitive cCRT administration;

  2. LA-HNSCC that was resected before definitive cCRT

  3. 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.

  • Receipt of the last dose of anticancer therapy (chemotherapy and/or RT) > 12 weeks (84 days) prior to randomization.

Study Design

Total Participants: 1145
Treatment Group(s): 1
Primary Treatment: volrustomig
Phase: 3
Study Start date:
December 14, 2023
Estimated Completion Date:
May 23, 2030

Connect with a study center

  • Research Site

    Graz, 8036
    Austria

    Site Not Available

  • Research Site

    Innsbruck, 6020
    Austria

    Site Not Available

  • Research Site

    Linz, 4010
    Austria

    Site Not Available

  • Research Site

    Salzburg, 5020
    Austria

    Site Not Available

  • Research Site

    Wien, 1080
    Austria

    Site Not Available

  • Research Site

    Charleroi, 6000
    Belgium

    Site Not Available

  • Research Site

    Edegem, 2650
    Belgium

    Site Not Available

  • Research Site

    Jette, 1090
    Belgium

    Site Not Available

  • Research Site

    La Louvière, 7100
    Belgium

    Site Not Available

  • Research Site

    Namur, 5000
    Belgium

    Site Not Available

  • 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

    Porto Alegre, 91350200
    Brazil

    Active - Recruiting

  • Research Site

    Ribeirão Preto, 14051-140
    Brazil

    Active - Recruiting

  • Research Site

    Rio de Janeiro, 20231-050
    Brazil

    Site Not Available

  • Research Site

    Sao Paulo, 01509-900
    Brazil

    Active - Recruiting

  • Research Site

    Teresina, 64049-200
    Brazil

    Active - Recruiting

  • Research Site

    Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • Research Site

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • Research Site

    Kelowna, British Columbia V1Y 5L3
    Canada

    Site Not Available

  • Research Site

    Kingston, Ontario K7L 2V7
    Canada

    Active - Recruiting

  • Research Site

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • Research Site

    Toronto, Ontario M4N 3M5
    Canada

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  • Research Site

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • Research Site

    Regina, S4T 7T1
    Canada

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  • Research Site

    Beijing, 100210
    China

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  • Research Site

    Bengbu, 233060
    China

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  • Research Site

    Changchun, 130000
    China

    Site Not Available

  • Research Site

    Changsha, 410008
    China

    Site Not Available

  • Research Site

    Chengdu, 610072
    China

    Site Not Available

  • Research Site

    Chongqing, 400016
    China

    Site Not Available

  • Research Site

    Fuzhou, 350014
    China

    Site Not Available

  • Research Site

    Guangzhou, 510060
    China

    Site Not Available

  • Research Site

    Guiyang, 550002
    China

    Site Not Available

  • Research Site

    Hangzhou, 310022
    China

    Site Not Available

  • Research Site

    Harbin, 150049
    China

    Site Not Available

  • Research Site

    Hefei, 230001
    China

    Site Not Available

  • Research Site

    Jinan, 250117
    China

    Site Not Available

  • Research Site

    Kunming, 650118
    China

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  • 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

    Tianjin, 300060
    China

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  • Research Site

    Tianjin Shi, 300060
    China

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  • Research Site

    Urumqi, 830000
    China

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  • Research Site

    Wuhan, 430030
    China

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  • Research Site

    Wuxi, 214122
    China

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  • Research Site

    Xiamen, 361003
    China

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  • Research Site

    Xian, 710061
    China

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    Zhengzhou, 450008
    China

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  • Research Site

    Avignon Cedex 09, 84918
    France

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  • Research Site

    Bordeaux, 33075
    France

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    Lyon, 69373
    France

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  • Research Site

    Saint Herblain, 44805
    France

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  • Research Site

    Toulouse Cedex 09, 31059
    France

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  • Research Site

    Villejuif, 94805
    France

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  • Research Site

    Berlin, 12200
    Germany

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  • Research Site

    Essen, 45122
    Germany

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    Greifswald, 17475
    Germany

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    Hamburg, 20246
    Germany

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    Hannover, 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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  • Research Site

    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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    Budapest, 1122
    Hungary

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    Győr, 9024
    Hungary

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    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

    Site Not Available

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    Bengaluru, 560027
    India

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    Hyderabad, 500032
    India

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    Jaipur, 302022
    India

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    Kanpur, 208005
    India

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  • Research Site

    Kochi, 682027
    India

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    Kolkata, 700099
    India

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  • Research Site

    Lucknow, 226003
    India

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    Madurai, 625107
    India

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    Mohali, 160055
    India

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    New Delhi, 110076
    India

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    Thiruvananthapuram, 695011
    India

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    Vadodara, 391760
    India

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    Varanasi, 221005
    India

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  • Research Site

    Aviano, 33081
    Italy

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    Firenze, 50139
    Italy

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    Milano, 20133
    Italy

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  • Research Site

    Modena, 41124
    Italy

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  • Research Site

    Napoli, 80131
    Italy

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  • Research Site

    Padova, 35128
    Italy

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  • Research Site

    Pavia, 27100
    Italy

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  • Research Site

    Rozzano, 20089
    Italy

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  • Research Site

    Bunkyo-ku, 113-8519
    Japan

    Active - Recruiting

  • Research Site

    Chiba-shi, 260-8717
    Japan

    Active - Recruiting

  • Research Site

    Chuo-ku, 104-0045
    Japan

    Active - Recruiting

  • Research Site

    Fukuoka, 811-1395
    Japan

    Active - Recruiting

  • Research Site

    Hiroshima-shi, 734-8551
    Japan

    Active - Recruiting

  • Research Site

    Kashiwa, 277-8577
    Japan

    Active - Recruiting

  • Research Site

    Kobe-shi, 650-0017
    Japan

    Active - Recruiting

  • Research Site

    Koto-ku, 135-8550
    Japan

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  • Research Site

    Morioka, 020-8505
    Japan

    Site Not Available

  • Research Site

    Nagoya-shi, 466-8560
    Japan

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  • Research Site

    Niigata-shi, 951-8520
    Japan

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  • Research Site

    Okayama-shi, 700-8558
    Japan

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  • Research Site

    Osaka-shi, 541-8567
    Japan

    Active - Recruiting

  • Research Site

    Osakasayama-shi, 589-8511
    Japan

    Active - Recruiting

  • Research Site

    Sapporo-shi, 060-8638
    Japan

    Active - Recruiting

  • Research Site

    Sendai-shi, 980-8574
    Japan

    Active - Recruiting

  • Research Site

    Shiwa-gun, 028-3695
    Japan

    Active - Recruiting

  • Research Site

    Sunto-gun, 411-8777
    Japan

    Active - Recruiting

  • Research Site

    Yokohama-shi, 241-8515
    Japan

    Active - Recruiting

  • Research Site

    Goyang-si, 410-769
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Gyeonggi-do, 13620
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Incheon, 21565
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Seoul, 5505
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Suwon, 16247
    Korea, Republic of

    Active - Recruiting

  • Research Site

    George Town, 10450
    Malaysia

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  • Research Site

    Johor Bahru, 81100
    Malaysia

    Active - Recruiting

  • Research Site

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Research Site

    Kuching, 93586
    Malaysia

    Active - Recruiting

  • Research Site

    Selangor, 62250
    Malaysia

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  • Research Site

    Białystok, 15-027
    Poland

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  • Research Site

    Bielsko-Biała, 43-300
    Poland

    Site Not Available

  • Research Site

    Gliwice, 44-102
    Poland

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  • Research Site

    Piotrków Trybunalski, 97-300
    Poland

    Site Not Available

  • Research Site

    Tomaszów Mazowiecki, 97-200
    Poland

    Site Not Available

  • Research Site

    Warszawa, 02-781
    Poland

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  • Research Site

    Badalona, 08916
    Spain

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  • Research Site

    Barcelona, 08036
    Spain

    Site Not Available

  • Research Site

    Jaén, 23007
    Spain

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  • Research Site

    Madrid, 28007
    Spain

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  • Research Site

    Valencia, 46026
    Spain

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  • Research Site

    València, 46014
    Spain

    Site Not Available

  • Research Site

    Changhua, 500
    Taiwan

    Active - Recruiting

  • Research Site

    Kaohsiung City, 833401
    Taiwan

    Active - Recruiting

  • Research Site

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei City, 11217
    Taiwan

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  • Research Site

    Bangkok, 10400
    Thailand

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  • Research Site

    Chaing Mai, 50200
    Thailand

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  • Research Site

    Hat Yai, 90110
    Thailand

    Active - Recruiting

  • Research Site

    Khon Kaen, 40002
    Thailand

    Active - Recruiting

  • Research Site

    Ankara, 6200
    Turkey

    Active - Recruiting

  • Research Site

    Antalya, 07059
    Turkey

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  • Research Site

    Istanbul, 34722
    Turkey

    Active - Recruiting

  • Research Site

    Karsiyaka, 35575
    Turkey

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  • Research Site

    Yenimahalle, 06170
    Turkey

    Active - Recruiting

  • Research Site

    Aberdeen, AB25 2ZN
    United Kingdom

    Active - Recruiting

  • Research Site

    Cambridge, CB2 0XY
    United Kingdom

    Active - Recruiting

  • Research Site

    Hampshire, SO16 6YD
    United Kingdom

    Site Not Available

  • Research Site

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Research Site

    London, SW3 6JJ
    United Kingdom

    Active - Recruiting

  • Research Site

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • Research Site

    Northwood, HA6 2RN
    United Kingdom

    Active - Recruiting

  • Research Site

    Sutton, SM2 5PT
    United Kingdom

    Active - Recruiting

  • Research Site

    Taunton, TA1 5DA
    United Kingdom

    Site Not Available

  • Research Site

    Wirral, CH63 4JY
    United Kingdom

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  • Research Site

    Birmingham, Alabama 35233
    United States

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  • Research Site

    Prescott Valley, Arizona 86314
    United States

    Active - Recruiting

  • Research Site

    Springdale, Arkansas 72762
    United States

    Active - Recruiting

  • Research Site

    Los Angeles, California 90024
    United States

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  • Research Site

    Orange, California 92868
    United States

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  • Research Site

    San Francisco, California 94143
    United States

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    Santa Rosa, California 95403
    United States

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  • Research Site

    Aurora, Colorado 80045
    United States

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  • Research Site

    Lone Tree, Colorado 80124
    United States

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  • Research Site

    Fort Myers, Florida 33901
    United States

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  • Research Site

    Gainesville, Florida 32610
    United States

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  • Research Site

    Miami, Florida 33125
    United States

    Site Not Available

  • Research Site

    Palm Bay, Florida 32909
    United States

    Active - Recruiting

  • Research Site

    West Palm Beach, Florida 33401
    United States

    Active - Recruiting

  • Research Site

    Niles, Illinois 60714
    United States

    Active - Recruiting

  • Research Site

    Des Moines, Iowa 50309
    United States

    Active - Recruiting

  • Research Site

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Research Site

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Research Site

    Baton Rouge, Louisiana 70817
    United States

    Active - Recruiting

  • Research Site

    Shreveport, Louisiana 71101
    United States

    Site Not Available

  • Research Site

    Baltimore, Maryland 21231
    United States

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  • Research Site

    Hyattsville, Maryland 20782
    United States

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  • Research Site

    Towson, Maryland 21204
    United States

    Active - Recruiting

  • Research Site

    Upper Marlboro, Maryland 20774
    United States

    Active - Recruiting

  • Research Site

    Boston, Massachusetts 02215
    United States

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  • Research Site

    Ann Arbor, Michigan 48105
    United States

    Active - Recruiting

  • Research Site

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

  • Research Site

    Columbia, Missouri 65211
    United States

    Site Not Available

  • Research Site

    Saint Louis, Missouri 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

    Site Not Available

  • Research Site

    Stony Brook, New York 11794
    United States

    Site Not Available

  • 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

    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

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Research Site

    Austin, Texas 78745
    United States

    Site Not Available

  • Research Site

    Dallas, Texas 75251
    United States

    Site Not Available

  • 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

    Site Not Available

  • 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

    Active - Recruiting

  • Research Site

    Spokane, Washington 99204
    United States

    Active - Recruiting

  • Research Site

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Research Site

    Hanoi, 100000
    Vietnam

    Active - Recruiting

  • Research Site

    Ho Chi Minh, 700000
    Vietnam

    Active - Recruiting

  • Research Site

    Ho Chi Minh City, 700000
    Vietnam

    Active - Recruiting

  • Research Site

    Vinh, 460000
    Vietnam

    Active - Recruiting

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