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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm | Experimental | Participants in this arm will receive volrustomig. |
|
| Observation Arm | No Intervention | Patients in this arm will undergo observation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| volrustomig | Drug | volrustomig |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors | PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause (in the absence of progression). The analysis will include all randomized participants with PD-L1 expressing tumors. | Up to approximately 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population | PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants. | Up to approximately 8 years |
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Inclusion Criteria:
Exclusion Criteria:
Histologically/cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including participants with squamous cell carcinoma of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland). Participants with >1 primary tumors are not eligible for the study.
Participants with any of the following:
Participants who have received radiotherapy (RT) alone as definitive local therapy for LA-HNSCC.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
| Name | Affiliation | Role |
|---|---|---|
| Robert Haddad, MD | Dana Farber Cancer Institute Massachusetts, USA | Study Chair |
| Lisa Licitra, MD | Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan Milan, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Birmingham | Alabama | 35233 | United States | |
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool .
Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| Landmark Progression-Free Survival (PFS) Rates | PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). These analyses will include participants with PD-L1 expressing tumors and all randomized participants. | Up to approximately 8 years |
| Overall Survival (OS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors | Overall survival (OS) is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants with PD-L1 expressing tumors. | Up to approximately 8 years |
| Landmark Overall Survival (OS) Rates | OS is defined as the time from randomization until the date of death due to any cause. These analyses will include participants with PD-L1 expressing tumors as randomized and all randomized participants. | Up to approximately 8 years |
| Overall Survival (OS) in the unresected LA-HNSCC ITT population | OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants. | Up to approximately 8 years |
| Progression Free Survival 2 (PFS2) | PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial investigator-assessed progression), after the start of the first subsequent therapy, or death from any cause, whichever occurs first. The date of the second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice. These analyses will include participants with PD-L1 expressing tumors as randomized and all randomized participants. | Up to approximately 8 years |
| Presence of Anti-Drug-Antibodies (ADAs) against volrustomig in serum | To investigate the immunogenicity of volrustomig. | Up to approximately 8 years |
| Participant-reported physical functioning | Change from baseline of physical functioning as measured by scores on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v.20 - Physical Function 8c are reported on a T score metric (mean = 50 and SD = 10), with higher scores reflecting better physical functioning. The analysis will include all randomized participants. | Up to approximately 8 years |
| Participant-reported global health status (GHS)/quality of life (QoL) | Change from baseline of Global Health Status/Quality of Life subscale scores as measured by the European Organization for Research and Treatment of Cancer (EORTC) Item Library 172 are transformed to a 0-100 range; a higher score represents higher quality of life. The analysis will include all randomized participants. | Up to approximately 8 years |
| Percentage of participants with Adverse Events | Adverse Events as assessed by Common Terminology Criteria for Adverse Events (CTCAE). | Up to approximately 8 years |
| Area under the curve (AUC) | The concentration of Volrustomig in serum will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered. | Up to approximately 8 years |
| Maximum plasma concentration of the drug (Cmax) | The concentration of Volrustomig in serum will be determined (Cmax will be derived). | Up to approximately 8 years |
| The time taken to reach the maximum concentration (Tmax) | The concentration of Volrustomig in serum will be determined (Tmax will be derived). | Up to approximately 8 years |
| Recruiting |
| Phoenix |
| Arizona |
| 85028 |
| United States |
| Research Site | Recruiting | Prescott Valley | Arizona | 86314 | United States |
| Research Site | Withdrawn | Springdale | Arkansas | 72762 | United States |
| Research Site | Recruiting | Fountain Valley | California | 92708 | United States |
| Research Site | Recruiting | Los Angeles | California | 90024 | United States |
| Research Site | Withdrawn | Orange | California | 92868 | United States |
| Research Site | Recruiting | San Francisco | California | 94143 | United States |
| Research Site | Recruiting | Santa Rosa | California | 95403 | United States |
| Research Site | Recruiting | Whittier | California | 90602 | United States |
| Research Site | Recruiting | Aurora | Colorado | 80045 | United States |
| Research Site | Recruiting | Colorado Springs | Colorado | 80909 | United States |
| Research Site | Recruiting | Lone Tree | Colorado | 80124 | United States |
| Research Site | Recruiting | Washington D.C. | District of Columbia | 20037 | United States |
| Research Site | Recruiting | Fort Myers | Florida | 33901 | United States |
| Research Site | Withdrawn | Gainesville | Florida | 32610 | United States |
| Research Site | Withdrawn | Miami | Florida | 33125 | United States |
| Research Site | Recruiting | Palm Bay | Florida | 32909 | United States |
| Research Site | Recruiting | West Palm Beach | Florida | 33401 | United States |
| Research Site | Recruiting | Niles | Illinois | 60714 | United States |
| Research Site | Recruiting | Des Moines | Iowa | 50309 | United States |
| Research Site | Completed | Kansas City | Kansas | 66160 | United States |
| Research Site | Recruiting | Louisville | Kentucky | 40202 | United States |
| Research Site | Recruiting | Baton Rouge | Louisiana | 70817 | United States |
| Research Site | Withdrawn | Shreveport | Louisiana | 71101 | United States |
| Research Site | Recruiting | Baltimore | Maryland | 21231 | United States |
| Research Site | Recruiting | Bethesda | Maryland | 20817 | United States |
| Research Site | Recruiting | Hyattsville | Maryland | 20782 | United States |
| Research Site | Recruiting | Towson | Maryland | 21204 | United States |
| Research Site | Recruiting | Upper Marlboro | Maryland | 20774 | United States |
| Research Site | Recruiting | Boston | Massachusetts | 02215 | United States |
| Research Site | Recruiting | Fairhaven | Massachusetts | 02719 | United States |
| Research Site | Recruiting | Ann Arbor | Michigan | 48105 | United States |
| Research Site | Withdrawn | Ann Arbor | Michigan | 48109 | United States |
| Research Site | Recruiting | Minneapolis | Minnesota | 55417 | United States |
| Research Site | Withdrawn | Columbia | Missouri | 65211 | United States |
| Research Site | Recruiting | St Louis | Missouri | 63110 | United States |
| Research Site | Withdrawn | St Louis | Missouri | 63110 | United States |
| Research Site | Withdrawn | East Brunswick | New Jersey | 08816 | United States |
| Research Site | Recruiting | Hackensack | New Jersey | 07601 | United States |
| Research Site | Recruiting | New Brunswick | New Jersey | 08901 | United States |
| Research Site | Recruiting | Albuquerque | New Mexico | 87108 | United States |
| Research Site | Recruiting | New York | New York | 10065 | United States |
| Research Site | Recruiting | New York | New York | 10075 | United States |
| Research Site | Recruiting | Stony Brook | New York | 11794 | United States |
| Research Site | Recruiting | Charlotte | North Carolina | 28204 | United States |
| Research Site | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| Research Site | Withdrawn | Cleveland | Ohio | 44106 | United States |
| Research Site | Withdrawn | Portland | Oregon | 97213 | United States |
| Research Site | Recruiting | Portland | Oregon | 97239 | United States |
| Research Site | Withdrawn | Philadelphia | Pennsylvania | 19107 | United States |
| Research Site | Recruiting | Pittsburgh | Pennsylvania | 15261 | United States |
| Research Site | Recruiting | York | Pennsylvania | 17403 | United States |
| Research Site | Recruiting | Sioux Falls | South Dakota | 57104 | United States |
| Research Site | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
| Research Site | Recruiting | Nashville | Tennessee | 37212 | United States |
| Research Site | Recruiting | Austin | Texas | 78745 | United States |
| Research Site | Recruiting | Dallas | Texas | 75251 | United States |
| Research Site | Withdrawn | Flower Mound | Texas | 75028 | United States |
| Research Site | Withdrawn | Houston | Texas | 77030 | United States |
| Research Site | Recruiting | Odessa | Texas | 79761 | United States |
| Research Site | Withdrawn | Tyler | Texas | 75702 | United States |
| Research Site | Recruiting | Salt Lake City | Utah | 84112 | United States |
| Research Site | Recruiting | West Jordan | Utah | 84088 | United States |
| Research Site | Recruiting | Fairfax | Virginia | 22031 | United States |
| Research Site | Recruiting | Norfolk | Virginia | 23502 | United States |
| Research Site | Withdrawn | Richmond | Virginia | 23230 | United States |
| Research Site | Withdrawn | Spokane | Washington | 99204 | United States |
| Research Site | Withdrawn | Tacoma | Washington | 98405 | United States |
| Research Site | Recruiting | Tacoma | Washington | 98415 | United States |
| Research Site | Recruiting | Graz | 8036 | Austria |
| Research Site | Recruiting | Innsbruck | 6020 | Austria |
| Research Site | Recruiting | Linz | 4010 | Austria |
| Research Site | Recruiting | Salzburg | 5020 | Austria |
| Research Site | Recruiting | Vienna | 1080 | Austria |
| Research Site | Recruiting | Charleroi | 6060 | Belgium |
| Research Site | Recruiting | Edegem | 2650 | Belgium |
| Research Site | Recruiting | Jette | 1090 | Belgium |
| Research Site | Recruiting | La Louvière | 7100 | Belgium |
| Research Site | Recruiting | Namur | 5000 | Belgium |
| Research Site | Recruiting | Barretos | 14784-400 | Brazil |
| Research Site | Recruiting | Florianópolis | 88034-000 | Brazil |
| Research Site | Recruiting | Fortaleza | 60336-045 | Brazil |
| Research Site | Recruiting | Ijuí | 98700-000 | Brazil |
| Research Site | Recruiting | Ipatinga | 35162-189 | Brazil |
| Research Site | Recruiting | Londrina | 86015-520 | Brazil |
| Research Site | Recruiting | Natal | 59075-740 | Brazil |
| Research Site | Recruiting | Porto Alegre | 91350200 | Brazil |
| Research Site | Suspended | Ribeirão Preto | 14051-140 | Brazil |
| Research Site | Suspended | Rio de Janeiro | 20231-050 | Brazil |
| Research Site | Recruiting | São Paulo | 01509-900 | Brazil |
| Research Site | Recruiting | São Paulo | 04538-132 | Brazil |
| Research Site | Recruiting | Teresina | 64049-200 | Brazil |
| Research Site | Recruiting | Calgary | Alberta | T2N 5G2 | Canada |
| Research Site | Recruiting | Edmonton | Alberta | T6G 1Z2 | Canada |
| Research Site | Recruiting | Kelowna | British Columbia | V1Y 5L3 | Canada |
| Research Site | Recruiting | Kingston | Ontario | K7L 2V7 | Canada |
| Research Site | Recruiting | London | Ontario | N6A 5W9 | Canada |
| Research Site | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
| Research Site | Not yet recruiting | Chicoutimi | Quebec | G7H 5H6 | Canada |
| Research Site | Completed | Montreal | Quebec | H2X 0C1 | Canada |
| Research Site | Terminated | Montreal | Quebec | H3T 1E2 | Canada |
| Research Site | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
| Research Site | Withdrawn | Regina | S4T 7T1 | Canada |
| Research Site | Recruiting | Beijing | 100142 | China |
| Research Site | Recruiting | Beijing | 100210 | China |
| Research Site | Recruiting | Bengbu | 233004 | China |
| Research Site | Withdrawn | Changchun | 130000 | China |
| Research Site | Recruiting | Changsha | 410008 | China |
| Research Site | Recruiting | Changsha | 410013 | China |
| Research Site | Recruiting | Chengdu | 610000 | China |
| Research Site | Recruiting | Chengdu | 610042 | China |
| Research Site | Recruiting | Chengdu | 610072 | China |
| Research Site | Recruiting | Chongqing | 400016 | China |
| Research Site | Recruiting | Chongqing | 400030 | China |
| Research Site | Recruiting | Dongwan | 523058 | China |
| Research Site | Recruiting | Fuzhou | 350014 | China |
| Research Site | Recruiting | Guangzhou | 510060 | China |
| Research Site | Recruiting | Guangzhou | 510080 | China |
| Research Site | Recruiting | Guangzhou | 510095 | China |
| Research Site | Recruiting | Guangzhou | 510700 | China |
| Research Site | Recruiting | Guiyang | 550002 | China |
| Research Site | Recruiting | Hangzhou | 310022 | China |
| Research Site | Recruiting | Harbin | 150049 | China |
| Research Site | Recruiting | Hefei | 230001 | China |
| Research Site | Recruiting | Huizhou | 516001 | China |
| Research Site | Recruiting | Jinan | 250117 | China |
| Research Site | Withdrawn | Kunming | 650118 | China |
| Research Site | Recruiting | Lanzhou | 730000 | China |
| Research Site | Recruiting | Nanchang | 330029 | China |
| Research Site | Recruiting | Nanning | 530021 | China |
| Research Site | Recruiting | Shanghai | 20032 | China |
| Research Site | Recruiting | Shenyang | 110004 | China |
| Research Site | Recruiting | Shijiazhuang | 050000 | China |
| Research Site | Recruiting | Tianjin | 300060 | China |
| Research Site | Withdrawn | Tianjin | 300060 | China |
| Research Site | Withdrawn | Ürümqi | 830000 | China |
| Research Site | Recruiting | Wuhan | 430030 | China |
| Research Site | Recruiting | Wuhan | 430060 | China |
| Research Site | Withdrawn | Wuxi | 214122 | China |
| Research Site | Recruiting | Xi'an | 710061 | China |
| Research Site | Withdrawn | Xiamen | 361003 | China |
| Research Site | Recruiting | Zhengzhou | 450008 | China |
| Research Site | Recruiting | Zhuhai | 519000 | China |
| Research Site | Recruiting | Avignon | 84918 | France |
| Research Site | Recruiting | Bordeaux | 33075 | France |
| Research Site | Recruiting | Le Mans | 72000 | France |
| Research Site | Recruiting | Lyon | 69373 | France |
| Research Site | Recruiting | Nice | 06100 | France |
| Research Site | Recruiting | Saint-Herblain | 44805 | France |
| Research Site | Recruiting | Toulouse | 31059 | France |
| Research Site | Recruiting | Villejuif | 94805 | France |
| Research Site | Recruiting | Berlin | 12200 | Germany |
| Research Site | Recruiting | Erlangen | 91054 | Germany |
| Research Site | Recruiting | Essen | 45122 | Germany |
| Research Site | Not yet recruiting | Freiburg im Breisgau | 79106 | Germany |
| Research Site | Recruiting | Greifswald | 17475 | Germany |
| Research Site | Recruiting | Hamburg | 20246 | Germany |
| Research Site | Recruiting | Hanover | 30625 | Germany |
| Research Site | Recruiting | Leipzig | 04103 | Germany |
| Research Site | Recruiting | Lübeck | 23538 | Germany |
| Research Site | Recruiting | München | 81675 | Germany |
| Research Site | Recruiting | Rostock | 18059 | Germany |
| Research Site | Recruiting | Tübingen | 72076 | Germany |
| Research Site | Recruiting | Ulm | 89075 | Germany |
| Research Site | Recruiting | Würzburg | 97070 | Germany |
| Research Site | Recruiting | Budapest | 1062 | Hungary |
| Research Site | Recruiting | Budapest | 1083 | Hungary |
| Research Site | Recruiting | Budapest | 1122 | Hungary |
| Research Site | Recruiting | Budapest | 1145 | Hungary |
| Research Site | Recruiting | Győr | 9024 | Hungary |
| Research Site | Recruiting | Gyula | 5700 | Hungary |
| Research Site | Recruiting | Kecskemét | 6000 | Hungary |
| Research Site | Recruiting | Miskolc | 3526 | Hungary |
| Research Site | Recruiting | Nyíregyháza | 4400 | Hungary |
| Research Site | Recruiting | Pécs | 7624 | Hungary |
| Research Site | Recruiting | Szekszárd | 7100 | Hungary |
| Research Site | Recruiting | Bengaluru | 560027 | India |
| Research Site | Recruiting | Hyderabad | 500032 | India |
| Research Site | Withdrawn | Jaipur | 302022 | India |
| Research Site | Recruiting | Kanpur | 208005 | India |
| Research Site | Recruiting | Kochi | 682027 | India |
| Research Site | Recruiting | Kolkata | 700099 | India |
| Research Site | Withdrawn | Lucknow | 226003 | India |
| Research Site | Recruiting | Madurai | 625107 | India |
| Research Site | Withdrawn | Mohali | 160055 | India |
| Research Site | Recruiting | Nashik | 422002 | India |
| Research Site | Recruiting | New Delhi | 110076 | India |
| Research Site | Recruiting | Thiruvananthapuram | 695011 | India |
| Research Site | Recruiting | Vadodara | 391760 | India |
| Research Site | Recruiting | Varanasi | 221005 | India |
| Research Site | Recruiting | Aviano | 33081 | Italy |
| Research Site | Recruiting | Florence | 50139 | Italy |
| Research Site | Recruiting | Milan | 20133 | Italy |
| Research Site | Recruiting | Modena | 41124 | Italy |
| Research Site | Recruiting | Naples | 80131 | Italy |
| Research Site | Recruiting | Padova | 35128 | Italy |
| Research Site | Recruiting | Pavia | 27100 | Italy |
| Research Site | Recruiting | Rozzano | 20089 | Italy |
| Research Site | Recruiting | Bunkyō City | 113-8431 | Japan |
| Research Site | Recruiting | Bunkyō City | 113-8519 | Japan |
| Research Site | Recruiting | Chiba | 260-8677 | Japan |
| Research Site | Recruiting | Chiba | 260-8717 | Japan |
| Research Site | Recruiting | Chūōku | 104-0045 | Japan |
| Research Site | Recruiting | Fukuoka | 811-1395 | Japan |
| Research Site | Recruiting | Hidaka-shi | 350-1298 | Japan |
| Research Site | Recruiting | Hiroshima | 734-8551 | Japan |
| Research Site | Recruiting | Kashiwa | 277-8577 | Japan |
| Research Site | Recruiting | Kobe | 650-0017 | Japan |
| Research Site | Recruiting | Kōtoku | 135-8550 | Japan |
| Research Site | Not yet recruiting | Kyoto | 606-8507 | Japan |
| Research Site | Recruiting | Nagoya | 464-8681 | Japan |
| Research Site | Recruiting | Nagoya | 466-8560 | Japan |
| Research Site | Recruiting | Niigata | 951-8520 | Japan |
| Research Site | Recruiting | Okayama | 700-8558 | Japan |
| Research Site | Recruiting | Osaka | 541-8567 | Japan |
| Research Site | Recruiting | Osakasayama-shi | 589-8511 | Japan |
| Research Site | Recruiting | Sagamihara-shi | 252-0375 | Japan |
| Research Site | Recruiting | Sapporo | 060-8638 | Japan |
| Research Site | Recruiting | Sendai | 980-8574 | Japan |
| Research Site | Recruiting | Shinjuku-ku | 160-0023 | Japan |
| Research Site | Recruiting | Shiwa-gun | 028-3695 | Japan |
| Research Site | Recruiting | Sunto-gun | 411-8777 | Japan |
| Research Site | Recruiting | Yokohama | 236-0004 | Japan |
| Research Site | Recruiting | Yokohama | 241-8515 | Japan |
| Research Site | Recruiting | George Town | 10450 | Malaysia |
| Research Site | Recruiting | Johor Bahru | 81100 | Malaysia |
| Research Site | Recruiting | Kuala Lumpur | 50586 | Malaysia |
| Research Site | Recruiting | Kuala Lumpur | 59100 | Malaysia |
| Research Site | Recruiting | Kuala Selangor | 62250 | Malaysia |
| Research Site | Recruiting | Kuching | 93586 | Malaysia |
| Research Site | Withdrawn | Cebu City | 6000 | Philippines |
| Research Site | Not yet recruiting | General Santos | 9500 | Philippines |
| Research Site | Not yet recruiting | Iloilo City | 5000 | Philippines |
| Research Site | Not yet recruiting | Manila | 1008 | Philippines |
| Research Site | Not yet recruiting | Pasig | 1605 | Philippines |
| Research Site | Withdrawn | Quezon City | 1112 | Philippines |
| Research Site | Withdrawn | West San Juan City | 1502 | Philippines |
| Research Site | Recruiting | Bialystok | 15-027 | Poland |
| Research Site | Recruiting | Bielsko-Biala | 43-300 | Poland |
| Research Site | Recruiting | Bydgoszcz | 85-796 | Poland |
| Research Site | Recruiting | Gliwice | 44-102 | Poland |
| Research Site | Recruiting | Olsztyn | 10-228 | Poland |
| Research Site | Recruiting | Piotrkow Trybunalski | 97-300 | Poland |
| Research Site | Recruiting | Siedlce | 08-110 | Poland |
| Research Site | Withdrawn | Tomaszów Mazowiecki | 97-200 | Poland |
| Research Site | Recruiting | Warsaw | 02-781 | Poland |
| Research Site | Completed | San Juan | 00927 | Puerto Rico |
| Research Site | Recruiting | Goyang-si | 410-769 | South Korea |
| Research Site | Recruiting | Gyeonggi-do | 13620 | South Korea |
| Research Site | Recruiting | Incheon | 21565 | South Korea |
| Research Site | Recruiting | Seoul | 06351 | South Korea |
| Research Site | Recruiting | Seoul | 3722 | South Korea |
| Research Site | Recruiting | Seoul | 5505 | South Korea |
| Research Site | Recruiting | Suwon | 16247 | South Korea |
| Research Site | Recruiting | Badalona | 08916 | Spain |
| Research Site | Recruiting | Barcelona | 08035 | Spain |
| Research Site | Recruiting | Barcelona | 08036 | Spain |
| Research Site | Recruiting | Jaén | 23007 | Spain |
| Research Site | Recruiting | Madrid | 28007 | Spain |
| Research Site | Recruiting | Madrid | 28034 | Spain |
| Research Site | Recruiting | Madrid | 28040 | Spain |
| Research Site | Recruiting | Valencia | 46014 | Spain |
| Research Site | Recruiting | Valencia | 46026 | Spain |
| Research Site | Recruiting | Changhua | 500 | Taiwan |
| Research Site | Recruiting | Kaohsiung City | 80756 | Taiwan |
| Research Site | Recruiting | Kaohsiung City | 833401 | Taiwan |
| Research Site | Recruiting | Taichung | 404 | Taiwan |
| Research Site | Recruiting | Taichung | 40705 | Taiwan |
| Research Site | Recruiting | Taipei | 10002 | Taiwan |
| Research Site | Recruiting | Taipei | 11217 | Taiwan |
| Research Site | Recruiting | Taoyuan | 333 | Taiwan |
| Research Site | Recruiting | Bangkok | 10300 | Thailand |
| Research Site | Recruiting | Bangkok | 10400 | Thailand |
| Research Site | Recruiting | Bangkok | 10700 | Thailand |
| Research Site | Recruiting | Chaing Mai | 50200 | Thailand |
| Research Site | Recruiting | Hat Yai | 90110 | Thailand |
| Research Site | Withdrawn | Khon Kaen | 40002 | Thailand |
| Research Site | Recruiting | Lampang | 52000 | Thailand |
| Research Site | Recruiting | Muang | 22000 | Thailand |
| Research Site | Recruiting | Mueang | 20000 | Thailand |
| Research Site | Recruiting | Ankara | 06230 | Turkey (Türkiye) |
| Research Site | Recruiting | Ankara | 6200 | Turkey (Türkiye) |
| Research Site | Recruiting | Antalya | 07059 | Turkey (Türkiye) |
| Research Site | Recruiting | Cordaleo | 35575 | Turkey (Türkiye) |
| Research Site | Recruiting | Eskişehir | 26040 | Turkey (Türkiye) |
| Research Site | Withdrawn | Istanbul | 34722 | Turkey (Türkiye) |
| Research Site | Recruiting | Yenimahalle | 06170 | Turkey (Türkiye) |
| Research Site | Recruiting | Aberdeen | AB25 2ZN | United Kingdom |
| Research Site | Recruiting | Cambridge | CB2 0XY | United Kingdom |
| Research Site | Recruiting | Hampshire | SO16 6YD | United Kingdom |
| Research Site | Recruiting | Leeds | LS9 7TF | United Kingdom |
| Research Site | Recruiting | London | EC1A 7BE | United Kingdom |
| Research Site | Withdrawn | London | SE1 9RT | United Kingdom |
| Research Site | Recruiting | London | SW3 6JJ | United Kingdom |
| Research Site | Recruiting | Manchester | M20 4BX | United Kingdom |
| Research Site | Withdrawn | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| Research Site | Recruiting | Northwood | HA6 2RN | United Kingdom |
| Research Site | Recruiting | Sutton | SM2 5PT | United Kingdom |
| Research Site | Recruiting | Taunton | TA1 5DA | United Kingdom |
| Research Site | Recruiting | Da Nang | 550000 | Vietnam |
| Research Site | Recruiting | Hanoi | 100000 | Vietnam |
| Research Site | Recruiting | Hà Nội | 100000 | Vietnam |
| Research Site | Recruiting | Ho Chi Minh City | 700000 | Vietnam |
| Research Site | Recruiting | Huế | 530000 | Vietnam |
| Research Site | Recruiting | Vinh | 460000 | Vietnam |