A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Start Date
4/14/2026
Completion Date
12/28/2030
Summary
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
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
FDC fianlimab+cemiplimab
Cemiplimab
Placebo
Conditions
Locations
University of California Los Angeles
Los Angeles, California 90024
United States
Orlando Health
Orlando, Florida 32806
United States
Emory University School of Medicine
Atlanta, Georgia 30308
United States
St. Elizabeth Healthcare
Edgewood, Kentucky 41017
United States
Norton Cancer Institute
Louisville, Kentucky 40202
United States
Henry Ford Cancer Institute/Henry Ford Health System
Detroit, Michigan 48202
United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska 68130
United States
Ohio State University
Columbus, Ohio 43210
United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
United States
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232
United States
Joe Arrington Cancer Research & Treatment Center
Lubbock, Texas 79410
United States
Renovatio Clinical
The Woodlands, Texas 77380
United States
Inova Schar Cancer Institute
Fairfax, Virginia 22031
United States
Wide Bay Hospital and Health Service - Cancer Care Services - Bundaberg
Bundaberg, Queensland 4670
Australia
Wide Bay Hospital and Health Service
Hervey Bay, Queensland 4655
Australia
Peter MacCallum Cancer Centre (PMCC)
Melbourne, Victoria 3050
Australia
Centre Jean Perrin
Clermont-Ferrand, Auvergne-Rhône 63011
France
Timone Hospital - AP-HM
Marseille, Bordeaux 13005
France
Hopital Europeen Geroges Pompidou AP-HP
Paris, Île-de-France Region 75015
France
Istituto Europeo di Oncologia
Milan, 20141
Italy
Hospital Universitario Virgen del Rocio
Seville, Andalusia 41013
Spain
Hospital Clinic
Barcelona, Catalonia 08036
Spain
Hospital Universitario de Navarra
Pamplona, Navarre 31008
Spain
Centro Oncologico de Galicia
A Coruña, 15009
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009
Spain