A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
Launched by GLAXOSMITHKLINE · Feb 5, 2024
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called Dostarlimab to see if it is safe and effective for adults with locally advanced head and neck cancer that cannot be surgically removed. Participants in the trial will have recently completed a specific type of treatment called chemoradiation (which is a combination of chemotherapy and radiation therapy) and will not have any signs of cancer spreading to other parts of the body. To be eligible, patients need to have a confirmed diagnosis of this type of cancer in areas such as the mouth or throat, and their tumors must show a specific marker called PD-L1.
If you join this study, you will be randomly assigned to receive either Dostarlimab or a placebo (a treatment that looks the same but has no active medication) after your chemoradiation treatment. The goal is to see how well Dostarlimab works compared to the placebo in preventing cancer from coming back. Throughout the trial, your health will be closely monitored to check for any side effects and to assess how well the treatment is working. This study is currently recruiting participants, and it is important to discuss with your doctor whether this trial might be a good option for you.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- Participants are eligible to be included in the study only if all of the following criteria apply:
- • Has newly diagnosed unresected 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 tissue demonstrating:
- • PD-L1 positive tumor status
- • If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 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, systemic therapy, targeted therapy, or radical surgery for management of head and neck cancer not considered part of CRT.
- • 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 experienced any of the following with prior immunotherapy: any 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 \[Stevens-Johnson Syndrome, toxic epidermal necrolysis, or DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) syndrome\], or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary.
- • Has undergone any major surgical procedure or experienced significant traumatic injury within 28 days prior to enrolment.
- • Has any history of interstitial lung disease or pneumonitis (past or current).
- • Has cirrhosis 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.
About Glaxosmithkline
GlaxoSmithKline (GSK) is a global healthcare company dedicated to improving the quality of human life by enabling people to do more, feel better, and live longer. With a strong focus on research and development, GSK specializes in pharmaceuticals, vaccines, and consumer health products. The company is committed to advancing innovative therapies and preventive measures across various therapeutic areas, including respiratory, oncology, immunology, and infectious diseases. GSK's collaborative approach and rigorous clinical trial processes underscore its dedication to delivering safe and effective healthcare solutions that meet the needs of patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Fort Worth, Texas, United States
Pavia, Lombardia, Italy
Lisboa, , Portugal
Los Angeles, California, United States
Washington, District Of Columbia, United States
Napoli, Campania, Italy
Milano, Lombardia, Italy
Coimbra, , Portugal
Wichita, Kansas, United States
Germantown, Tennessee, United States
Tacoma, Washington, United States
Jonesboro, Arkansas, United States
Hannover, Niedersachsen, Germany
Faro, , Portugal
Madrid, , Spain
Nashville, Tennessee, United States
Melbourne, Victoria, Australia
Bruxelles, , Belgium
Edegem, , Belgium
Toronto, Ontario, Canada
Beijing, , China
Dijon Cedex, , France
Tel Aviv, , Israel
Taipei, , Taiwan
Torrance, California, United States
Tamarac, Florida, United States
Omaha, Nebraska, United States
Cincinnati, Ohio, United States
Charleston, South Carolina, United States
Fairfax, Virginia, United States
Herston, Queensland, Australia
Gent, , Belgium
Yvoir, , Belgium
Poitiers Cedex, , France
Augsburg, Bayern, Germany
Athens, , Greece
Roma, Lazio, Italy
Pamplona, , Spain
Atlanta, Georgia, United States
Lexington, Kentucky, United States
Charleroi, , Belgium
New York, New York, United States
Vancouver, British Columbia, Canada
Sutton, Surrey, United Kingdom
London, , United Kingdom
Olsztyn, , Poland
Berlin, , Germany
Montreal, Quebec, Canada
Zaragoza, , Spain
Saint Louis, Missouri, United States
Erlangen, Bayern, Germany
Thessaloniki, , Greece
Mumbai, , India
Porto Alegre, Rio Grande Do Sul, Brazil
New Haven, Connecticut, United States
Hamburg, , Germany
Chattanooga, Tennessee, United States
Göteborg, , Sweden
Barcelona, , Spain
Nottingham, , United Kingdom
Greenville, South Carolina, United States
Marseille, , France
Straubing, Bayern, Germany
Douglas, Queensland, Australia
Fort Wayne, Indiana, United States
Columbia, Maryland, United States
Győr, , Hungary
Cordoba, , Argentina
Rozzano (Mi), Lombardia, Italy
Santa Barbara, California, United States
Praha 8, , Czechia
Nanning, Guangxi, China
Hamilton, Ontario, Canada
Uppsala, , Sweden
Santander, , Spain
Geelong, Victoria, Australia
Kaohsiung, , Taiwan
Hangzhou, Zhejiang, China
Stockton, California, United States
Tottori, , Japan
Ehime, , Japan
Tokyo, , Japan
Zhengzhou, Henan, China
Poitiers, , France
Valenciennes, , France
Gloucester, , United Kingdom
Shanghai, , China
Saitama, , Japan
Jinan, Shandong, China
Changhua, , Taiwan
Bergen, , Norway
Sutton, , United Kingdom
Pavia, , Italy
Timisoara, , Romania
Aichi, , Japan
Shizuoka, , Japan
Barretos, São Paulo, Brazil
Olomouc, , Czechia
Hokkaido, , Japan
Fukuoka, , Japan
Cluj Napoca, , Romania
Worcester, Massachusetts, United States
Ballarat, Victoria, Australia
Salamanca, , Spain
Bucharest, , Romania
Chiba, , Japan
Giessen, , Germany
Koszalin, , Poland
Tromsø, , Norway
Oradea, , Romania
Salvador, Bahía, Brazil
Niigata, , Japan
Warszawa, , Poland
Fuzhou, Fujian, China
Kanagawa, , Japan
Edinburgh, , United Kingdom
Blacktown, New South Wales, Australia
Surat, , India
Ankara, , Turkey
Tokyo, , Japan
Taichung, , Taiwan
Guangzhou, , China
Zlin, , Czechia
Goteborg, , Sweden
Busan, , Korea, Republic Of
Hyogo, , Japan
Iasi, , Romania
Hefei, , China
Nanchang, , China
Hyderabad, , India
Vijayawada, , India
Bielsko Biala, , Poland
Pitesti, , Romania
Lugo, , Spain
Changsha, , China
Sao Paulo, , Brazil
Seoul, , Korea, Republic Of
Rouen Cedex 1, , France
Fuzhou, , China
Nanning, , China
Suwon, , Korea, Republic Of
Haifa, , Israel
Milano, , Italy
Oslo, , Norway
Porto, , Portugal
Changsha, Hunan, China
Wolverhampton, , United Kingdom
(Barakaldo) Vizcaya, , Spain
Rennes Cedex, , France
Napoli, , Italy
Guadalajara, Jalisco, Mexico
Padova, , Italy
Iowa City, Iowa, United States
Prague, , Czechia
Kyoto, , Japan
Busan, , Korea, Republic Of
Athens, , Greece
Salgótarján, , Hungary
Wolverhampton, West Midlands, United Kingdom
Taiyuan, , China
Chengdu, Sichuan, China
Siedlce, , Poland
Floresti, , Romania
Solvang, California, United States
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Kolkata, , India
Essen, Nordrhein Westfalen, Germany
Vitória, Espírito Santo, Brazil
São Paulo, , Brazil
Guangzhou, Guangdong, China
Nanchang, Jiangxi, China
Iwate, , Japan
Miyagi, , Japan
Zhuhai, , China
Zhengzhou, , China
Joinville, Santa Catarina, Brazil
Savona, Liguria, Italy
Osaka, , Japan
Gliwice, , Poland
Stockholm, , Sweden
Belo Horizonte, Minas Gerais, Brazil
Viedma, Río Negro, Argentina
Xiamen, , China
Dongguan, Guangdong, China
Chengdu, , China
Buenos Aires, , Argentina
Vila Nova De Gaia, , Portugal
Bhubaneshwar, Odisha, , India
Ankara, , Turkey
Istanbul, , Turkey
Rosario, Santa Fe, Argentina
Jerusalem, , Israel
Roma, , Italy
Katowice, , Poland
Sao Jose Do Rio Preto, São Paulo, Brazil
Oaxaca De Juarez, Oaxaca, Mexico
Caen Cedex 5, , France
Rouen, , France
Przemysl, , Poland
Pitesti, Arges, Romania
Craiova, , Romania
Suceava, , Romania
Fredericksburg, Virginia, United States
Larissa, , Greece
Matosinhos, , Portugal
Florianopolis, Santa Catarina, Brazil
Farmington, Connecticut, United States
Capital Federal, Buenos Aires, Argentina
San Miguel De Tucumán, Tucumán, Argentina
San Juan, , Argentina
Douglas, , Australia
Praha, , Czechia
Vandœuvre Lès Nancy Cedex, , France
Stuttgart, Baden Wuerttemberg, Germany
Efkarpia, , Greece
Kaposvar, , Hungary
Nyíregyháza, , Hungary
Ciudad De Mexico, , Mexico
Bucuresti, , Romania
Antalya, , Turkey
Nottingham,, , United Kingdom
Hangzhou, , China
Istanbul, , Turkey
Blacksburg, Virginia, United States
Ciudad Autonoma De Buenos Aires, , Argentina
Wuhan, Hebei, China
Linyi, , China
Shenyang, , China
Vijayawada, Andhra Pradesh, India
Bengaluru, Karnataka, India
Nehru Nagar, Belagavi, Karnataka, India
Hyderabad, Telengana, India
Kolkata, West Bengal, India
Nashik, , India
Thiruvananthapuram, , India
Jerez De La Frontera, Cádiz, Spain
Cartagena, Murcia, Spain
Hannover, , Germany
Rosario, , Argentina
Essen, , Germany
Montreal, , Canada
Toronto, , Canada
Marseille Cedex 5, , France
Rozzano Mi, , Italy
Ciudad Autonoma De Buenos Aire, , Argentina
San Miguel De Tucuman, , Argentina
Viedma, , Argentina
Ballarat, , Australia
Blacktown, , Australia
Geelong, , Australia
Herston, , Australia
Melbourne, , Australia
Barretos, , Brazil
Belo Horizonte, , Brazil
Florianopolis, , Brazil
Joinville, , Brazil
Porto Alegre, , Brazil
Salvador, , Brazil
Sao Jose Do Rio Preto, , Brazil
Vitoria, , Brazil
Hamilton, , Canada
Vancouver, , Canada
Changzhou, , China
Dongguan, , China
Guangzhou, , China
Hengyang, , China
Jinan, , China
Lanzhou, , China
Wuhan, , China
Valenciennes Cedex, , France
Vanduvre Les Nancy Cedex, , France
Augsburg, , Germany
Erlangen, , Germany
Straubing, , Germany
Nyiregyhaza, , Hungary
Salgotarjan, , Hungary
Bengaluru, , India
Bhubaneswar, , India
Nehru Nagar Belagavi Karnataka 590010, , India
Trivandrum, , India
Prato, , Italy
Savona, , Italy
Pusan, , Korea, Republic Of
Suwon Gyeonggi Do, , Korea, Republic Of
Guadalajara, , Mexico
Oaxaca, , Mexico
Troms, , Norway
Baracaldovizcaya, , Spain
Cartagena Murcia, , Spain
Hebron, , Spain
Jerez, , Spain
L'hospitalet De Llobrega, , Spain
Craiova, , Romania
Chongqing, Chongqing, China
Wytheville, Virginia, United States
Charleroi, , Belgium
Quimper Cedex, , France
Vandoeuvre Les Nancy Cedex, , France
Adapazari, , Turkey
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported