RecruitingPhase 3NCT06256588

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

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Dostarlimab as Sequential Therapy After Chemoradiation in Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

Sponsor

GlaxoSmithKline

Enrollment

864 participants

Start Date

Mar 21, 2024

Study Type

INTERVENTIONAL

Conditions

Neoplasms, Head and Neck

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether dostarlimab (an immunotherapy drug) given after standard chemo-radiation (cisplatin + radiotherapy) improves outcomes in people with locally advanced head and neck cancers. The cancers involved are in the mouth, throat, voice box, or lower throat region. The immunotherapy is added after the completion of standard treatment to help the immune system eliminate remaining cancer cells. **You may be eligible if...** - You have been newly diagnosed with locally advanced squamous cell cancer of the oral cavity, oropharynx, hypopharynx, or larynx - You have completed standard chemo-radiation with curative intent and have no evidence of distant spread - Your tumor tests positive for PD-L1 - Your general health is good (ECOG status 0–1) with adequate organ function **You may NOT be eligible if...** - You have had surgery for this cancer before chemo-radiation - You have evidence of cancer spread to distant organs - You have significant autoimmune disease or are on immunosuppressive medications - You have previously received an anti-PD-1 or anti-PD-L1 drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDostarlimab

Dostarlimab will be administered as an intravenous (IV) infusion

DRUGPlacebo

Placebo will be administered as an IV infusion

Locations(240)

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Solvang, California, United States

GSK Investigational Site

Stockton, California, United States

GSK Investigational Site

Torrance, California, United States

GSK Investigational Site

Farmington, Connecticut, United States

GSK Investigational Site

New Haven, Connecticut, United States

GSK Investigational Site

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

GSK Investigational Site

St. Petersburg, Florida, United States

GSK Investigational Site

Tamarac, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Fort Wayne, Indiana, United States

GSK Investigational Site

Iowa City, Iowa, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Columbia, Maryland, United States

GSK Investigational Site

Worcester, Massachusetts, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Greenville, South Carolina, United States

GSK Investigational Site

Chattanooga, Tennessee, United States

GSK Investigational Site

Germantown, Tennessee, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Fort Worth, Texas, United States

GSK Investigational Site

Fredericksburg, Virginia, United States

GSK Investigational Site

Wytheville, Virginia, United States

GSK Investigational Site

Tacoma, Washington, United States

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Córdoba, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

San Juan, Argentina

GSK Investigational Site

San Miguel de Tucumán, Argentina

GSK Investigational Site

Viedma, Argentina

GSK Investigational Site

Blacktown, New South Wales, Australia

GSK Investigational Site

Douglas, Queensland, Australia

GSK Investigational Site

Herston, Queensland, Australia

GSK Investigational Site

Ballarat, Victoria, Australia

GSK Investigational Site

Geelong, Victoria, Australia

GSK Investigational Site

Melbourne, Victoria, Australia

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Charleroi, Belgium

GSK Investigational Site

Edegem, Belgium

GSK Investigational Site

Ghent, Belgium

GSK Investigational Site

Yvoir, Belgium

GSK Investigational Site

Barretos, Brazil

GSK Investigational Site

Belo Horizonte, Brazil

GSK Investigational Site

Florianópolis, Brazil

GSK Investigational Site

Ijuí, Brazil

GSK Investigational Site

Jaú, Brazil

GSK Investigational Site

Joinville, Brazil

GSK Investigational Site

Natal, Brazil

GSK Investigational Site

Porto Alegre, Brazil

GSK Investigational Site

Salvador, Brazil

GSK Investigational Site

Salvador, Brazil

GSK Investigational Site

São José do Rio Preto, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

Vitória, Brazil

GSK Investigational Site

Hamilton, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Chongqing, Chongqing Municipality, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Changsha, China

GSK Investigational Site

Changzhou, China

GSK Investigational Site

Chengdu, China

GSK Investigational Site

Chengdu, China

GSK Investigational Site

Dongguan, China

GSK Investigational Site

Fuzhou, China

GSK Investigational Site

Fuzhou, China

GSK Investigational Site

Guangzhou, China

GSK Investigational Site

Hangzhou, China

GSK Investigational Site

Hangzhou, China

GSK Investigational Site

Hefei, China

GSK Investigational Site

Hengyang, China

GSK Investigational Site

Jinan, China

GSK Investigational Site

Linyi, China

GSK Investigational Site

Nanchang, China

GSK Investigational Site

Nanchang, China

GSK Investigational Site

Nanning, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Taiyuan, China

GSK Investigational Site

Wuhan, China

GSK Investigational Site

Wuhan, China

GSK Investigational Site

Xiamen, China

GSK Investigational Site

Zhengzhou, China

GSK Investigational Site

Zhuhai, China

GSK Investigational Site

Olomouc, Czechia

GSK Investigational Site

Prague, Czechia

GSK Investigational Site

Prague, Czechia

GSK Investigational Site

Prague, Czechia

GSK Investigational Site

Zlín, Czechia

GSK Investigational Site

Caen, France

GSK Investigational Site

Dijon, France

GSK Investigational Site

Marseille, France

GSK Investigational Site

Poitiers, France

GSK Investigational Site

Quimper, France

GSK Investigational Site

Rennes, France

GSK Investigational Site

Rouen, France

GSK Investigational Site

Vandœuvre-lès-Nancy, France

GSK Investigational Site

Augsburg, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Erlangen, Germany

GSK Investigational Site

Essen, Germany

GSK Investigational Site

Giessen, Germany

GSK Investigational Site

Hamburg, Germany

GSK Investigational Site

Neuruppin, Germany

GSK Investigational Site

Straubing, Germany

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Larissa, Greece

GSK Investigational Site

Thessaloniki, Greece

GSK Investigational Site

Győr, Hungary

GSK Investigational Site

Kaposvár, Hungary

GSK Investigational Site

Nyíregyháza, Hungary

GSK Investigational Site

Bengaluru, India

GSK Investigational Site

Bhubaneswar, India

GSK Investigational Site

Hyderabad, India

GSK Investigational Site

Mumbai, India

GSK Investigational Site

Nashik, India

GSK Investigational Site

Nehru Nagar Belagavi Karnataka 590010, India

GSK Investigational Site

Surat, India

GSK Investigational Site

Vijayawada, India

GSK Investigational Site

Ashdod, Israel

GSK Investigational Site

Haifa, Israel

GSK Investigational Site

Jerusalem, Israel

GSK Investigational Site

Tel Aviv, Israel

GSK Investigational Site

Bologna, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Naples, Italy

GSK Investigational Site

Pavia, Italy

GSK Investigational Site

Prato, Italy

GSK Investigational Site

Roma, Italy

GSK Investigational Site

Roma, Italy

GSK Investigational Site

Rozzano MI, Italy

GSK Investigational Site

Savona, Italy

GSK Investigational Site

Aichi, Japan

GSK Investigational Site

Aomori, Japan

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Ehime, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Gunma, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Hyōgo, Japan

GSK Investigational Site

Hyōgo, Japan

GSK Investigational Site

Kagoshima, Japan

GSK Investigational Site

Kanagawa, Japan

GSK Investigational Site

Kanagawa, Japan

GSK Investigational Site

Kyoto, Japan

GSK Investigational Site

Miyagi, Japan

GSK Investigational Site

Niigata, Japan

GSK Investigational Site

Numakunai, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Saitama, Japan

GSK Investigational Site

Shizuoka, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Tottori, Japan

GSK Investigational Site

Guadalajara, Mexico

GSK Investigational Site

Mexico City, Mexico

GSK Investigational Site

Mexico City, Mexico

GSK Investigational Site

Oaxaca City, Mexico

GSK Investigational Site

Bergen, Norway

GSK Investigational Site

Oslo, Norway

GSK Investigational Site

Troms, Norway

GSK Investigational Site

Bielsko-Biala, Poland

GSK Investigational Site

Gliwice, Poland

GSK Investigational Site

Katowice, Poland

GSK Investigational Site

Olsztyn, Poland

GSK Investigational Site

Przemyśl, Poland

GSK Investigational Site

Siedlce, Poland

GSK Investigational Site

Warsaw, Poland

GSK Investigational Site

Coimbra, Portugal

GSK Investigational Site

Faro, Portugal

GSK Investigational Site

Lisbon, Portugal

GSK Investigational Site

Lisbon, Portugal

GSK Investigational Site

Matosinhos Municipality, Portugal

GSK Investigational Site

Porto, Portugal

GSK Investigational Site

Porto, Portugal

GSK Investigational Site

Vila Nova de Gaia, Portugal

GSK Investigational Site

Bucharest, Romania

GSK Investigational Site

Bucharest, Romania

GSK Investigational Site

Craiova, Romania

GSK Investigational Site

Craiova, Romania

GSK Investigational Site

Floreşti, Romania

GSK Investigational Site

Iași, Romania

GSK Investigational Site

Oradea, Romania

GSK Investigational Site

Piteşti, Romania

GSK Investigational Site

Suceava, Romania

GSK Investigational Site

Timișoara, Romania

GSK Investigational Site

Busan, South Korea

GSK Investigational Site

Pusan, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Suwon Gyeonggi-do, South Korea

GSK Investigational Site

BaracaldoVizcaya, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Cartagena Murcia, Spain

GSK Investigational Site

HebrOn, Spain

GSK Investigational Site

Jerez de la Frontera, Spain

GSK Investigational Site

L'Hospitalet de Llobrega, Spain

GSK Investigational Site

Lugo, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Pamplona, Spain

GSK Investigational Site

Salamanca, Spain

GSK Investigational Site

Santander, Spain

GSK Investigational Site

Zaragoza, Spain

GSK Investigational Site

Gothenburg, Sweden

GSK Investigational Site

Stockholm, Sweden

GSK Investigational Site

Uppsala, Sweden

GSK Investigational Site

Changhua, Taiwan

GSK Investigational Site

Kaohsiung City, Taiwan

GSK Investigational Site

Taichung, Taiwan

GSK Investigational Site

Taipei, Taiwan

GSK Investigational Site

Adapazarı, Turkey (Türkiye)

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Antalya, Turkey (Türkiye)

GSK Investigational Site

Istanbul, Turkey (Türkiye)

GSK Investigational Site

Istanbul, Turkey (Türkiye)

GSK Investigational Site

Istanbul, Şişli, Turkey (Türkiye)

GSK Investigational Site

Edinburgh, United Kingdom

GSK Investigational Site

Gloucester, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

Nottingham, United Kingdom

GSK Investigational Site

Sutton, United Kingdom

GSK Investigational Site

Wolverhampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06256588