This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab compared against cemiplimab combined with placebo (a placebo looks like a treatment but does not contain any real medicine), collectively called "study drugs" in this form. The study is focused on participants with head and neck cancers who have not been previously treated for head and neck cancer that has come back or spread to other parts of the body, referred to as recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much of each study drug is in the blood at different times * Whether the body makes antibodies against the study drug(s) individually (which could make the study drugs less effective or could lead to side effects) * Compatible research to better understand the study drugs and HNSCC
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Fixed-Dose Combination (FDC) Administered per the protocol
Administered per the protocol
Administered per the protocol
Overall Response Rate (ORR)
Time frame: Up to 90 days after last study treatment, approximately 58 months
Incidence of Adverse Events (AEs)
Time frame: Up to 90 days after last study treatment, approximately 58 months
Severity of AEs
Time frame: Up to 90 days after last study treatment, approximately 58 months
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 90 days after last study treatment, approximately 58 months
Incidence of immune-mediated Adverse Events (imAEs)
Time frame: Up to 90 days after last study treatment, approximately 58 months
Incidence of treatment-related AEs
Time frame: Up to 90 days after last study treatment, approximately 58 months
Incidence of Adverse Events of Special Interest (AESIs)
Time frame: Up to 90 days after last study treatment, approximately 58 months
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 90 days after last study treatment, approximately 58 months
Incidence of AEs leading to discontinuation
Time frame: Up to 90 days after last study treatment, approximately 58 months
Incidence of AEs leading to death
Time frame: Up to 90 days after last study treatment, approximately 58 months
Incidence of laboratory abnormalities
Per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Time frame: Up to 90 days after last study treatment, approximately 58 months
Disease Control Rate (DCR) per investigator assessment
Time frame: Up to 90 days after last study treatment, approximately 58 months
Duration of Response (DOR) per investigator assessment or death, whichever occurs first
Time frame: Up to 90 days after last study treatment, approximately 58 months
Progression-Free Survival (PFS) per investigator assessment or death, whichever occurs first
Time frame: Up to 90 days after last study treatment, approximately 58 months
Concentrations of cemiplimab in serum
Time frame: Up to 90 days after last study treatment, approximately 58 months
Concentrations of fianlimab in serum
Time frame: Up to 90 days after last study treatment, approximately 58 months
Incidence of Anti-Drug Antibody (ADA) to fianlimab
Time frame: Up to 90 days after last study treatment, approximately 58 months
Titer of ADA to fianlimab
Time frame: Up to 90 days after last study treatment, approximately 58 months
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