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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony histopatologicznie zaawansowany rak płaskonabłonkowy głowy i szyi, który wrócił lub rozprzestrzenił się i nie może być operacyjnie wyleczony
- •Guz pierwotny w jamie ustnej, gardle, krtani lub dołku podgardziałowym
- •Wynik badania PD-L1 ≥1 (marker z biopsji wykonanej przed badaniem)
- •Co najmniej jeden zmierzywalny guz
- •Stan ogólny pacjenta pozwalający na leczenie (0-1 w skali ECOG)
- •Prawidłowe funkcje nerek i szpiku kostnego
✗ Disqualifies
- •Pogorszenie choroby w ciągu 6 miesięcy po chemioterapii na nowotwór głowy i szyi
- •Guz pierwotny w nosogardli, zatok przynosowych lub grucołach ślinowych
- •Rak głowy i szyi z nieznanym miejscem powstania
- •Aktywna choroba autoimmunologiczna wymagająca leczenia w ciągu ostatnich 5 lat
- •Historia zapalenia płuc lub choroby śródmiąższu płuc
- •Poważne choroby serca, w tym zawały, zapalenie mięśnia sercowego
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 15, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (25)
University of California Los Angeles
Los Angeles, United States
Orlando Health
Orlando, United States
Emory University School of Medicine
Atlanta, United States
St. Elizabeth Healthcare
Edgewood, United States
Norton Cancer Institute
Louisville, United States
Henry Ford Cancer Institute/Henry Ford Health System
Detroit, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, United States
Ohio State University
Columbus, United States
Asplundh Cancer Pavilion
Willow Grove, United States
University of Tennessee Medical Center
Knoxville, United States
Vanderbilt-Ingram Cancer Center
Nashville, United States
Joe Arrington Cancer Research & Treatment Center
Lubbock, United States
Renovatio Clinical
The Woodlands, United States
Inova Schar Cancer Institute
Fairfax, United States
Wide Bay Hospital and Health Service - Cancer Care Services - Bundaberg
Bundaberg, Australia
Peter MacCallum Cancer Centre (PMCC)
Melbourne, Australia
Centre Jean Perrin
Clermont-Ferrand, France
Timone Hospital - AP-HM
Marseille, France
Hopital Europeen Geroges Pompidou AP-HP
Paris, France
Istituto Europeo di Oncologia
Milan, Italy
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Clinic
Barcelona, Spain
Hospital Universitario de Navarra
Pamplona, Spain
Centro Oncologico de Galicia
A Coruña, Spain
Hospital Universitario La Paz
Madrid, Spain
Trial contact
Clinical Trials Administrator
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/16/2026.
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