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NCT06256588PHASE3Recruiting

A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

GlaxoSmithKline

Start Date

3/21/2024

Completion Date

10/26/2029

Summary

The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with Head and Neck Squamous Cell Carcinoma (HNSCC)

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Has newly diagnosed unresected Locally Advanced (LA) histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx or larynx and completed cisplatin plus radiotherapy (termed "CRT" in this protocol) with curative intent and has no evidence of distant metastatic disease. * Has provided acceptable core or excisional biopsy obtained prior to CRT: * PD-L1 positive tumor status * If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 immunohistochemistry (IHC) testing. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Has adequate organ function. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Has received prior radiation therapy (RT), systemic therapy, targeted therapy, or surgery for management of head and neck cancer not considered part of CRT. Participants receiving induction chemotherapy are excluded. CRT combinations with components other than cisplatin and RT (e.g., experimental agents, including radiosensitizers/radioprotectants, cetuximab) are not eligible. * Has cancer outside of the oropharynx, larynx, hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer. Has more than one primary HNSCC tumor. * Has experienced any of the following with prior immunotherapy: any immune-related adverse event (irAE) of Grade ≥3, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or Drug Rash with Eosinophilia and Systemic Symptoms \[DRESS\] syndrome), or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary. * Has undergone any major surgical procedure or experienced significant traumatic injury that has not resolved by the time of randomization. * Has any history of interstitial lung disease or pneumonitis (past or current). * Has cirrhosis of any stage or current unstable liver biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice. * Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study intervention, or indicate it is not in the best interest of the participant to participate, in the opinion of the investigator. * Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention. * Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or coinhibitory T-cell receptor \[e.g., Cytotoxic T-lymphocyte associated protein 4 (CTLA4), OX-40, CD137\] * Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 120 days after the last dose of study intervention. * Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab or its excipients.

Interventions

DRUG

Dostarlimab

DRUG

Placebo

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Conditions

Neoplasms, Head and Neck

Locations

GSK Investigational Site

Jonesboro, Arkansas 72401

United States

GSK Investigational Site

Los Angeles, California 90095

United States

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Solvang, California 93463

United States

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Stockton, California 95204

United States

GSK Investigational Site

Torrance, California 90505

United States

GSK Investigational Site

Farmington, Connecticut 06030-1628

United States

GSK Investigational Site

New Haven, Connecticut 06520

United States

GSK Investigational Site

Washington D.C., District of Columbia 20010

United States

GSK Investigational Site

St. Petersburg, Florida 33709

United States

GSK Investigational Site

Tamarac, Florida 33321

United States

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Atlanta, Georgia 30322

United States

GSK Investigational Site

Fort Wayne, Indiana 46804

United States

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Iowa City, Iowa 52242

United States

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Lexington, Kentucky 40536

United States

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Columbia, Maryland 21044

United States

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Worcester, Massachusetts 01655-0002

United States

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St Louis, Missouri 63110

United States

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Omaha, Nebraska 68114

United States

GSK Investigational Site

New York, New York 10032

United States

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The Bronx, New York 10468

United States

GSK Investigational Site

Canton, Ohio 44718

United States

GSK Investigational Site

Cincinnati, Ohio 45219

United States

GSK Investigational Site

Tulsa, Oklahoma 74146

United States

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Philadelphia, Pennsylvania 19107

United States

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Pittsburgh, Pennsylvania 15212

United States

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Charleston, South Carolina 29425

United States

GSK Investigational Site

Greenville, South Carolina 29607

United States

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Chattanooga, Tennessee 37404

United States

GSK Investigational Site

Germantown, Tennessee 38138

United States

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Nashville, Tennessee 37203

United States

GSK Investigational Site

Dallas, Texas 75246

United States

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Fort Worth, Texas 76104

United States

GSK Investigational Site

San Antonio, Texas 78217

United States

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Fredericksburg, Virginia 22408

United States

GSK Investigational Site

Wytheville, Virginia 24382

United States

GSK Investigational Site

Tacoma, Washington 98405

United States

GSK Investigational Site

Buenos Aires, 1023

Argentina

GSK Investigational Site

Buenos Aires, C1425

Argentina

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Buenos Aires, C1437GZT

Argentina

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Ciudad Autonoma de Buenos Aire, C1426

Argentina

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Córdoba, 5000

Argentina

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Florida, 1602

Argentina

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Rosario, S2002

Argentina

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San Juan, J5400

Argentina

GSK Investigational Site

San Miguel de Tucumán, T4000GTB

Argentina

GSK Investigational Site

Viedma, R8500ACE

Argentina

GSK Investigational Site

Blacktown, New South Wales 2148

Australia

GSK Investigational Site

Douglas, Queensland 4814

Australia

GSK Investigational Site

Herston, Queensland 4029

Australia

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Ballarat, Victoria 3350

Australia

GSK Investigational Site

Geelong, Victoria 3220

Australia

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Melbourne, Victoria 3004

Australia

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Brussels, 1200

Belgium

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Charleroi, 6060

Belgium

GSK Investigational Site

Edegem, 2650

Belgium

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Ghent, 9000

Belgium

GSK Investigational Site

Liège, 4000

Belgium

GSK Investigational Site

Yvoir, 5530

Belgium

GSK Investigational Site

Barretos, 14784-400

Brazil

GSK Investigational Site

Belo Horizonte, 30110-022

Brazil

GSK Investigational Site

Florianópolis, 88020-210

Brazil

GSK Investigational Site

Ijuí, 98700-000

Brazil

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Jaú, 17210-120

Brazil

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Joinville, 89201-260

Brazil

GSK Investigational Site

Natal, 59075-740

Brazil

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Porto Alegre, 90610-000

Brazil

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Salvador, 41253-190

Brazil

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Salvador, 41950-640

Brazil

GSK Investigational Site

São José do Rio Preto, 15090-200

Brazil

GSK Investigational Site

São Paulo, 01246-000

Brazil

GSK Investigational Site

Vitória, 29043-260

Brazil

GSK Investigational Site

Greater Sudbury, Ontario P3E 5J1

Canada

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Hamilton, Ontario L8V 5C2

Canada

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Toronto, Ontario M5G 2M9

Canada

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Montreal, Quebec H3T 1E2

Canada

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Chongqing, Chongqing Municipality 400030

China

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Baoding, Hebei 071000

China

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Nanyang, Henan 473005

China

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Beijing, 100036

China

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Changsha, 410013

China

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Changzhou, 213032

China

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Chengdu, 610000

China

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Chengdu, 610041

China

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Dongguan, 523059

China

GSK Investigational Site

Fuzhou, 350005

China

GSK Investigational Site

Fuzhou, 350014

China

GSK Investigational Site

Guangzhou, 510120

China

GSK Investigational Site

Guangzhou, 510503

China

GSK Investigational Site

Hangzhou, 310003

China

GSK Investigational Site

Hangzhou, 310022

China

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Hefei, 230001

China

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Hengyang, 421000

China

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Jinan, 250117

China

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Kunming, 650106

China

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Lanzhou, 730030

China

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Linyi, 276002

China

GSK Investigational Site

Nanchang, 330006

China

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Nanchang, 330029

China

GSK Investigational Site

Nanning, 530021

China

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Shanghai, 200032

China

GSK Investigational Site

Taiyuan, 030013

China

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Wuhan, 430030

China

GSK Investigational Site

Wuhan, 430079

China

GSK Investigational Site

Xiamen, 361004

China

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Xuzhou, 221004

China

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Zhengzhou, 450052

China

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Zhuhai, 519001

China

GSK Investigational Site

Olomouc, 779 00

Czechia

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Prague, 10034

Czechia

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Prague, 150 08

Czechia

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Prague, 180 81

Czechia

GSK Investigational Site

Zlín, 76275

Czechia

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Ars-Laquenexy, 57530

France

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Caen, 14075

France

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Dijon, 21079

France

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Marseille, 13005

France

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Poitiers, 86021

France

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Quimper, 29000

France

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Rennes, 35042

France

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Rouen, 76038

France

GSK Investigational Site

Vandœuvre-lès-Nancy, 54519

France

GSK Investigational Site

Augsburg, 86156

Germany

GSK Investigational Site

Berlin, 12351

Germany

GSK Investigational Site

Berlin, 13353

Germany

GSK Investigational Site

Erlangen, 91054

Germany

GSK Investigational Site

Essen, 45147

Germany

GSK Investigational Site

Giessen, 35392

Germany

GSK Investigational Site

Hamburg, 22087

Germany

GSK Investigational Site

Neuruppin, 16816

Germany

GSK Investigational Site

Straubing, 94315

Germany

GSK Investigational Site

Athens, 115 22

Greece

GSK Investigational Site

Athens, 12462

Greece

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Larissa, 41100

Greece

GSK Investigational Site

Thessaloniki, 564 29

Greece

GSK Investigational Site

Győr, 9023

Hungary

GSK Investigational Site

Kaposvár, 7400

Hungary

GSK Investigational Site

Nyíregyháza, H-4400

Hungary

GSK Investigational Site

Mumbai, Maharashtra 400071

India

GSK Investigational Site

Pune, Maharashtra 411001

India

GSK Investigational Site

Bengaluru, 560066

India

GSK Investigational Site

Bhubaneswar, 751019

India

GSK Investigational Site

Gurgaon, 122001

India

GSK Investigational Site

Hyderabad, 500004

India

GSK Investigational Site

Mumbai, 400012

India

GSK Investigational Site

Nashik, 422002

India

GSK Investigational Site

Nehru Nagar Belagavi Karnataka 590010, 590010

India

GSK Investigational Site

Surat, 395002

India

GSK Investigational Site

Vijayawada, 520002

India

GSK Investigational Site

Ashdod, 7747629

Israel

GSK Investigational Site

Haifa, 3109601

Israel

GSK Investigational Site

Jerusalem, 9112001

Israel

GSK Investigational Site

Tel Aviv, 64239

Israel

GSK Investigational Site

Bolzano, Prov. Aut. Bolzano-Alto Adige 39100

Italy

GSK Investigational Site

Bologna, 40139

Italy

GSK Investigational Site

Milan, 20133

Italy

GSK Investigational Site

Milan, 20141

Italy

GSK Investigational Site

Naples, 80131

Italy

GSK Investigational Site

Pavia, 27100

Italy

GSK Investigational Site

Prato, 59100

Italy

GSK Investigational Site

Roma, 00161

Italy

GSK Investigational Site

Roma, 00168

Italy

GSK Investigational Site

Rozzano MI, 20089

Italy

GSK Investigational Site

Savona, 17100

Italy

GSK Investigational Site

Aichi, 464-8681

Japan

GSK Investigational Site

Aomori, 036-8563

Japan

GSK Investigational Site

Chiba, 260-8717

Japan

GSK Investigational Site

Chiba, 277-8577

Japan

GSK Investigational Site

Ehime, 791-0280

Japan

GSK Investigational Site

Fukuoka, 812-8582

Japan

GSK Investigational Site

Gunma, 371-8511

Japan

GSK Investigational Site

Hokkaido, 060-8648

Japan

GSK Investigational Site

Hyōgo, 650-0017

Japan

GSK Investigational Site

Hyōgo, 673-8558

Japan

GSK Investigational Site

Kagoshima, 890-8520

Japan

GSK Investigational Site

Kanagawa, 236-0004

Japan

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Kanagawa, 252-0375

Japan

GSK Investigational Site

Kanagawa, 259-1193

Japan

GSK Investigational Site

Kyoto, 612-8555

Japan

GSK Investigational Site

Miyagi, 981-1293

Japan

GSK Investigational Site

Niigata, 951-8520

Japan

GSK Investigational Site

Numakunai, 028-3695

Japan

GSK Investigational Site

Okinawa, 901-2725

Japan

GSK Investigational Site

Osaka, 541-8567

Japan

GSK Investigational Site

Saitama, 350-1298

Japan

GSK Investigational Site

Shizuoka, 411-8777

Japan

GSK Investigational Site

Tokyo, 105-8471

Japan

GSK Investigational Site

Tokyo, 113-8519

Japan

GSK Investigational Site

Tokyo, 152-8902

Japan

GSK Investigational Site

Tokyo, 160-0023

Japan

GSK Investigational Site

Tottori, 683-8504

Japan

GSK Investigational Site

Guadajalara, 44280

Mexico

GSK Investigational Site

Guadalajara, 44650

Mexico

GSK Investigational Site

Mexico City, 06760

Mexico

GSK Investigational Site

Mexico City, 11510

Mexico

GSK Investigational Site

Monterrey, 66260

Mexico

GSK Investigational Site

Oaxaca City, 68020

Mexico

GSK Investigational Site

Bergen, 5021

Norway

GSK Investigational Site

Oslo, 0379

Norway

GSK Investigational Site

Troms, 9038

Norway

GSK Investigational Site

Bielsko-Biala, 43-300

Poland

GSK Investigational Site

Gliwice, 44-102

Poland

GSK Investigational Site

Katowice, 40-514

Poland

GSK Investigational Site

Olsztyn, 10-228

Poland

GSK Investigational Site

Przemyśl, 37-700

Poland

GSK Investigational Site

Siedlce, 08-110

Poland

GSK Investigational Site

Warsaw, 04-141

Poland

GSK Investigational Site

Coimbra, 3000-075

Portugal

GSK Investigational Site

Faro, 8000-386

Portugal

GSK Investigational Site

Lisbon, 1649-035

Portugal

GSK Investigational Site

Lisbon, 1998-018

Portugal

GSK Investigational Site

Matosinhos Municipality, 4464-509

Portugal

GSK Investigational Site

Porto, 4200-072

Portugal

GSK Investigational Site

Porto, 4200-319

Portugal

GSK Investigational Site

Vila Nova de Gaia, 4434-502

Portugal

GSK Investigational Site

Bucharest, 013823

Romania

GSK Investigational Site

Bucharest, 020142

Romania

GSK Investigational Site

Craiova, 200508

Romania

GSK Investigational Site

Craiova, 200542

Romania

GSK Investigational Site

Floreşti, 407280

Romania

GSK Investigational Site

Iași, 700483

Romania

GSK Investigational Site

Oradea, 410469

Romania

GSK Investigational Site

Piteşti, 110283

Romania

GSK Investigational Site

Suceava, 720214

Romania

GSK Investigational Site

Timișoara, 300239

Romania

GSK Investigational Site

Riyadh, 12372

Saudi Arabia

GSK Investigational Site

Riyadh,

Saudi Arabia

GSK Investigational Site

Singapore, 168583

Singapore

GSK Investigational Site

Singapore, 308433

Singapore

GSK Investigational Site

Busan, 602-030

South Korea

GSK Investigational Site

Pusan, 49241

South Korea

GSK Investigational Site

Seoul, 03722

South Korea

GSK Investigational Site

Seoul, 06351

South Korea

GSK Investigational Site

Seoul, 110 744

South Korea

GSK Investigational Site

Suwon Gyeonggi-do, 16247

South Korea

GSK Investigational Site

BaracaldoVizcaya, 48903

Spain

GSK Investigational Site

Barcelona, 08023

Spain

GSK Investigational Site

Cartagena Murcia, 30202

Spain

GSK Investigational Site

HebrOn, 08035

Spain

GSK Investigational Site

Jerez de la Frontera, 11407

Spain

GSK Investigational Site

L'Hospitalet de Llobrega, 08908

Spain

GSK Investigational Site

Lugo, 27003

Spain

GSK Investigational Site

Madrid, 28040

Spain

GSK Investigational Site

Madrid, 28041

Spain

GSK Investigational Site

Madrid, 28046

Spain

GSK Investigational Site

Pamplona, 31008

Spain

GSK Investigational Site

Salamanca, 37007

Spain

GSK Investigational Site

Santander, 39008

Spain

GSK Investigational Site

Zaragoza, 50009

Spain

GSK Investigational Site

Gothenburg, SE-413 45

Sweden

GSK Investigational Site

Stockholm, SE-171 64

Sweden

GSK Investigational Site

Uppsala, SE-751 85

Sweden

GSK Investigational Site

Basel, 4031

Switzerland

GSK Investigational Site

Fribourg, 1708

Switzerland

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Geneva, 1211

Switzerland

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Lausanne, 1011

Switzerland

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Zurich, 8091

Switzerland

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Changhua, 500

Taiwan

GSK Investigational Site

Kaohsiung City, 833

Taiwan

GSK Investigational Site

Taichung, 40447

Taiwan

GSK Investigational Site

Taipei, 100

Taiwan

GSK Investigational Site

Adapazarı,

Turkey (Türkiye)

GSK Investigational Site

Ankara, 06010

Turkey (Türkiye)

GSK Investigational Site

Ankara, 06100

Turkey (Türkiye)

GSK Investigational Site

Ankara, 06520

Turkey (Türkiye)

GSK Investigational Site

Antalya, 7050

Turkey (Türkiye)

GSK Investigational Site

Istanbul, 34010

Turkey (Türkiye)

GSK Investigational Site

Istanbul, 34662

Turkey (Türkiye)

GSK Investigational Site

Istanbul, Şişli 34384

Turkey (Türkiye)

GSK Investigational Site

Abu Dhabi,

United Arab Emirates

GSK Investigational Site

Al Ain City,

United Arab Emirates

GSK Investigational Site

Dubai,

United Arab Emirates

GSK Investigational Site

Edinburgh, EH4 2XU

United Kingdom

GSK Investigational Site

Gloucester, GL1 3NN

United Kingdom

GSK Investigational Site

London, SW3 6JJ

United Kingdom

GSK Investigational Site

Nottingham, NG5 1PB

United Kingdom

GSK Investigational Site

Sutton, SM2 5PT

United Kingdom

GSK Investigational Site

Wolverhampton, WV10 0QP

United Kingdom