RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT06769698

Registry updated: 2026-10-15

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Description

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

Interventions

FDC fianlimab+cemiplimab (Drug)
Fixed-Dose Combination (FDC) Administered per the protocol
Cemiplimab (Drug)
Administered per the protocol
Placebo (Drug)
Administered per the protocol

Eligibility criteria

Key Inclusion Criteria: 1. Have histologically confirmed (by local pathology) R/M HNSCC that is considered incurable by local therapies 2. Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx (patients with cervical neck node SCC with occult primary as described in the protocol 3. PD-L1 expression Combined Positive Score (CPS) ≥1 documented with a previously PD-L1 obtained Immunohistochemistry (IHC) result prior to screening, as described in protocol 4. Oropharynx cancer participants only: HPV status, based on a previously documented result prior to screening, must have been established in a surgical biopsy specimen or a core biopsy specimen as described in the protocol 5. At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as described in the protocol 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 7. Adequate organ and bone marrow function as described in the protocol Key Exclusion Criteria: Medical Conditions 1. Participants who have Progressive Disease (PD) within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC as described in the protocol 2. Participants who have a primary tumor site of nasopharynx, paranasal sinus or salivary gland (any histology) 3. Head and neck SCC with unknown primary site as described in the protocol 4. Participants with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date as described in the protocol 5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management 6. History or current evidence of significant cardiovascular disease including, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classification III and IV), unstable angina, serious uncontrolled arrhythmia, and myocardial infarction 6 months prior to study enrollment. Prior/Concomitant Therapy 7. Participants who have received prior systemic anticancer therapy in the R/M HNSCC setting as described in the protocol 8. Participants with a condition requiring corticosteroid therapy (\>10 mg prednisone/prednisolone/day or equivalent) within 14 days of the first dose of study drug as described in the protocol Note: Other protocol defined Inclusion/ Exclusion Criteria apply

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Locations

University of California Los Angeles — Los Angeles, California, United States
Samuel Oschin Cancer Center — Los Angeles, California, United States
Orlando Health — Orlando, Florida, United States
Emory University School of Medicine — Atlanta, Georgia, United States
Northwestern University — Evanston, Illinois, United States
St. Elizabeth Healthcare — Edgewood, Kentucky, United States
Norton Cancer Institute — Louisville, Kentucky, United States
Henry Ford Cancer Institute/Henry Ford Health System — Detroit, Michigan, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists — Omaha, Nebraska, United States
University of Rochester — Rochester, New York, United States
Ohio State University — Columbus, Ohio, United States
Asplundh Cancer Pavilion — Willow Grove, Pennsylvania, United States
University of Tennessee Medical Center — Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
Joe Arrington Cancer Research & Treatment Center — Lubbock, Texas, United States
Renovatio Clinical — The Woodlands, Texas, United States
Inova Schar Cancer Institute — Fairfax, Virginia, United States
Virginia Commonwealth University Massey Cancer Center — Richmond, Virginia, United States
Wide Bay Hospital and Health Service - Cancer Care Services - Bundaberg — Bundaberg, Queensland, Australia
Cairns Hospital — Cairns, Queensland, Australia
Wide Bay Hospital and Health Service — Hervey Bay, Queensland, Australia
Peter MacCallum Cancer Centre (PMCC) — Melbourne, Victoria, Australia
Centre Jean Perrin — Clermont-Ferrand, Auvergne-Rhône, France
Timone Hospital - AP-HM — Marseille, Bordeaux, France
Hopital Europeen Geroges Pompidou AP-HP — Paris, Île-de-France Region, France
IRCCS Ospedale San Raffaele — Milan, Lombardy, Italy
Humanitas Cancer Center — Pieve Emanuele, Milan, Italy
Istituto Europeo di Oncologia — Milan, Italy
Hospital Universitario Virgen del Rocio — Seville, Andalusia, Spain
Hospital Clinic — Barcelona, Catalonia, Spain
Complejo Hospitalario Universitario de a Coruna — A Coruña, Galicia, Spain
Hospital Universitario de Navarra — Pamplona, Navarre, Spain
Centro Oncologico de Galicia — A Coruña, Spain
University Hospital Vall d'Hebron — Barcelona, Spain
Hospital Universitario La Paz — Madrid, Spain
Hospital Universitario Miguel Servet — Zaragoza, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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