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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
864
Dostarlimab will be administered as an intravenous (IV) infusion
Placebo will be administered as an IV infusion
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 Concomitant Chemoradiotherapy (CRT) when invasive cancer is present or Death from any cause.
Time frame: Up to approximately 5 years
Overall Survival (OS)
OS is defined as the time from date of randomization to the date of death by any cause.
Time frame: Up to approximately 5 years
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
Time frame: Up to approximately 5 years
Number of Participants with treatment emergent adverse events (TEAEs), Immune-mediated TEAEs, and serious adverse events (SAEs) by severity
Time frame: Up to approximately 5 years
Number of Participants with TEAEs and SAEs leading to dose delays, withdrawals or death
Time frame: Up to approximately 5 years
Number of participants with clinically significant changes in laboratory, vital signs, and safety assessment parameters
Time frame: Up to approximately 5 years
Serum Concentration of Dostarlimab
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GSK Investigational Site
Jonesboro, Arkansas, United States
RECRUITINGGSK Investigational Site
Los Angeles, California, United States
RECRUITINGGSK Investigational Site
Solvang, California, United States
RECRUITINGGSK Investigational Site
Stockton, California, United States
RECRUITINGGSK Investigational Site
Torrance, California, United States
RECRUITINGGSK Investigational Site
Farmington, Connecticut, United States
RECRUITINGGSK Investigational Site
New Haven, Connecticut, United States
RECRUITINGGSK Investigational Site
Washington D.C., District of Columbia, United States
RECRUITINGGSK Investigational Site
St. Petersburg, Florida, United States
RECRUITINGGSK Investigational Site
Tamarac, Florida, United States
WITHDRAWN...and 267 more locations
Time frame: Up to approximately 15 months
Serum Concentration of Dostarlimab at End of Infusion (C-EoI)
Time frame: Up to approximately 15 months
Serum Predose trough concentration (Ctrough) of Dostarlimab
Time frame: Up to approximately 15 months
Number of Participants with Anti-Drug Antibodies against Dostarlimab
Time frame: Up to approximately 15 months