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

Neoplasms, Head and Neck Clinical Trial

— JADE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06256588
• Other study ID #: 221530
• Secondary ID: 2023-508613-17-0
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 4, 2024
• Est. completion date: July 13, 2029

Study information

• Verified date: January 2024
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 864
• Est. completion date: July 13, 2029
• Est. primary completion date: June 9, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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, CD134).
• 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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Neoplasms, Head and Neck
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Dostarlimab
Dostarlimab will be administered as an intravenous (IV) infusion
• Placebo
Placebo will be administered as an IV infusion

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Capital Federal	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires
Argentina	GSK Investigational Site	Cordoba
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	San Juan
Argentina	GSK Investigational Site	San Miguel de Tucumán	Tucumán
Argentina	GSK Investigational Site	Viedma	Río Negro
Australia	GSK Investigational Site	Ballarat	Victoria
Australia	GSK Investigational Site	Blacktown	New South Wales
Australia	GSK Investigational Site	Douglas
Australia	GSK Investigational Site	Geelong	Victoria
Australia	GSK Investigational Site	Herston	Queensland
Australia	GSK Investigational Site	Melbourne	Victoria
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Charleroi
Belgium	GSK Investigational Site	Edegem
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Yvoir
Brazil	GSK Investigational Site	Barretos	São Paulo
Brazil	GSK Investigational Site	Belo Horizonte	Minas Gerais
Brazil	GSK Investigational Site	Florianopolis	Santa Catarina
Brazil	GSK Investigational Site	Joinville	Santa Catarina
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	Salvador	Bahía
Brazil	GSK Investigational Site	Salvador	Bahía
Brazil	GSK Investigational Site	Sao Jose Do Rio Preto	São Paulo
Brazil	GSK Investigational Site	São Paulo
Brazil	GSK Investigational Site	Vitória	Espírito Santo
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Toronto	Ontario
Czechia	GSK Investigational Site	Prague
Czechia	GSK Investigational Site	Praha
Czechia	GSK Investigational Site	Praha 8
Czechia	GSK Investigational Site	Zlin
France	GSK Investigational Site	Caen Cedex 5
France	GSK Investigational Site	Dijon Cedex
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Poitiers cedex
France	GSK Investigational Site	Rennes Cedex
France	GSK Investigational Site	Valenciennes
France	GSK Investigational Site	Vandœuvre-lès-Nancy Cedex
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Erlangen	Bayern
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Straubing	Bayern
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Efkarpia
Greece	GSK Investigational Site	Larissa
Hungary	GSK Investigational Site	Gyor
Hungary	GSK Investigational Site	Kaposvar
Hungary	GSK Investigational Site	Nyíregyháza
Hungary	GSK Investigational Site	Salgótarján
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Pavia	Lombardia
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Rozzano (MI)	Lombardia
Italy	GSK Investigational Site	Savona	Liguria
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Ehime
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hyogo
Japan	GSK Investigational Site	Iwate
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kyoto
Japan	GSK Investigational Site	Miyagi
Japan	GSK Investigational Site	Niigata
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
Korea, Republic of	GSK Investigational Site	Busan
Korea, Republic of	GSK Investigational Site	Busan
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Suwon
Mexico	GSK Investigational Site	Ciudad de Mexico
Mexico	GSK Investigational Site	Ciudad de Mexico
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Oaxaca de Juarez	Oaxaca
Norway	GSK Investigational Site	Bergen
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Tromsø
Poland	GSK Investigational Site	Bielsko-Biala
Poland	GSK Investigational Site	Gliwice
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Koszalin
Poland	GSK Investigational Site	Olsztyn
Poland	GSK Investigational Site	Przemysl
Poland	GSK Investigational Site	Siedlce
Poland	GSK Investigational Site	Warszawa
Portugal	GSK Investigational Site	Coimbra
Portugal	GSK Investigational Site	Faro
Portugal	GSK Investigational Site	Lisboa
Portugal	GSK Investigational Site	Lisboa
Portugal	GSK Investigational Site	Matosinhos
Portugal	GSK Investigational Site	Porto
Portugal	GSK Investigational Site	Porto
Portugal	GSK Investigational Site	Vila Nova de Gaia
Romania	GSK Investigational Site	Bucuresti
Romania	GSK Investigational Site	Cluj-Napoca
Romania	GSK Investigational Site	Craiova
Romania	GSK Investigational Site	Craiova
Romania	GSK Investigational Site	Iasi
Romania	GSK Investigational Site	Oradea
Romania	GSK Investigational Site	Pitesti	Arges
Romania	GSK Investigational Site	Suceava
Romania	GSK Investigational Site	Timisoara
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Uppsala
Taiwan	GSK Investigational Site	Changhua
Taiwan	GSK Investigational Site	Kaohsiung
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Taipei
Turkey	GSK Investigational Site	Ankara
Turkey	GSK Investigational Site	Antalya
Turkey	GSK Investigational Site	Istanbul
United Kingdom	GSK Investigational Site	Edinburgh
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Nottingham,
United Kingdom	GSK Investigational Site	Sutton	Surrey
United Kingdom	GSK Investigational Site	Wolverhampton	West Midlands
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Farmington	Connecticut
United States	GSK Investigational Site	Germantown	Tennessee
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	New Haven	Connecticut
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Stockton	California
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Czechia,  France,  Germany,  Greece,  Hungary,  Italy,  Japan,  Korea, Republic of,  Mexico,  Norway,  Poland,  Portugal,  Romania,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)	Event Free Survival (EFS) is defined as the time from the date of randomization to the date of an event, where an event is defined as locoregional progression or recurrence, or distant metastasis per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as per BICR; Salvage surgery at the primary tumor site; Neck dissection or surgery performed >20 weeks after completion of or Death from any cause.	Up to approximately 5 years
Secondary	Overall Survival (OS)	OS is defined as the time from date of randomization to the date of death by any cause.	Up to approximately 5 years
Secondary	Event-free Survival (EFS) assessed by investigator	Event Free Survival (EFS) is defined as the time from the date of randomization to the date of an event as per primary endpoint, however with investigator assessment per RECIST 1.1	Up to approximately 5 years
Secondary	Number of Participants with treatment emergent adverse events (TEAEs), Immune-mediated TEAEs, and serious adverse events (SAEs) by severity		Up to approximately 5 years
Secondary	Number of Participants with TEAEs and SAEs leading to dose delays, withdrawals or death		Up to approximately 5 years
Secondary	Number of participants with clinically significant changes in laboratory, vital signs, and safety assessment parameters		Up to approximately 5 years
Secondary	Serum Concentration of Dostarlimab		Up to approximately 15 months
Secondary	Serum Concentration of Dostarlimab at End of Infusion (C-EoI)		Up to approximately 15 months
Secondary	Serum Predose trough concentration (Ctrough) of Dostarlimab		Up to approximately 15 months
Secondary	Number of Participants with Anti-Drug Antibodies against Dostarlimab		Up to approximately 15 months