The primary purpose of the study is to evaluate the antitumor activity and safety of novel immunotherapy combinations compared with dostarlimab in participants with Programmed death ligand 1 (PD-L1) positive Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
316
Dostarlimab will be administered.
Belrestotug will be administered.
Nelistotug will be administered.
Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy
Confirmed ORR is defined as the percentage of participants achieving confirmed Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment.
Time frame: Up to approximately 24 months
Rate of Circulating Tumor Deoxyribonucleic Acid (ctDNA) Molecular Response
The rate of ctDNA molecular response, is defined as the percentage of participants achieving a ≥50% decrease in ctDNA level compared to baseline, measured by plasma ctDNA assessment.
Time frame: Up to approximately 24 months
Number of Participants with Treatment Emergent Adverse Events (AEs), treatment emergent Serious Adverse Events (SAE) and treatment emergent Adverse Events of Special Interest (AESI)
Time frame: Up to approximately 24 months
Number of Participants with TEAEs leading to dose modifications or study intervention discontinuation
Time frame: Up to approximately 24 months
Number of Participants with Clinically Significant Findings in Vital signs, Electrocardiogram (ECG), and Laboratory test parameters
Time frame: Up to approximately 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Remzistotug will be administered.
GSK Investigational Site
New Haven, Connecticut, United States
GSK Investigational Site
Iowa City, Iowa, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Columbus, Ohio, United States
GSK Investigational Site
Milwaukee, Wisconsin, United States
GSK Investigational Site
Buenos Aires, Argentina
GSK Investigational Site
Capital Federal, Argentina
GSK Investigational Site
Ciudad Autonoma de Bueno, Argentina
GSK Investigational Site
Córdoba, Argentina
GSK Investigational Site
Florida, Argentina
...and 100 more locations