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NCT06769698PHASE2Recruiting

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

Regeneron Pharmaceuticals

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

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

Interventions

DRUG

FDC fianlimab+cemiplimab

DRUG

Cemiplimab

DRUG

Placebo

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Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

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