FDC fianlimab+cemiplimab: Fixed-Dose Combination (FDC) Administered per the protocol
Cemiplimab: Administered per the protocol
Placebo: Administered per the protocol
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
| Facility | City | Region | Status |
|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | Recruiting |
| Samuel Oschin Cancer Center | Los Angeles | California | Recruiting |
| Orlando Health | Orlando | Florida | Recruiting |
| Emory University School of Medicine | Atlanta | Georgia | Recruiting |
| Northwestern University | Evanston | Illinois | Recruiting |
| St. Elizabeth Healthcare | Edgewood | Kentucky | Recruiting |
| Norton Cancer Institute | Louisville | Kentucky | Recruiting |
| Henry Ford Cancer Institute/Henry Ford Health System | Detroit | Michigan | Recruiting |
| Oncology Hematology West P.C. dba Nebraska Cancer Specialists | Omaha | Nebraska | Recruiting |
| University of Rochester | Rochester | New York | Recruiting |
| Ohio State University | Columbus | Ohio | Recruiting |
| Asplundh Cancer Pavilion | Willow Grove | Pennsylvania | Recruiting |
| University of Tennessee Medical Center | Knoxville | Tennessee | Recruiting |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | Recruiting |
| Joe Arrington Cancer Research & Treatment Center | Lubbock | Texas | Recruiting |
| Renovatio Clinical | The Woodlands | Texas | Recruiting |
| Inova Schar Cancer Institute | Fairfax | Virginia | Recruiting |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | Recruiting |
| Wide Bay Hospital and Health Service - Cancer Care Services - Bundaberg | Bundaberg | Queensland | Recruiting |
| Cairns Hospital | Cairns | Queensland | Recruiting |
| Wide Bay Hospital and Health Service | Hervey Bay | Queensland | Recruiting |
| Peter MacCallum Cancer Centre (PMCC) | Melbourne | Victoria | Recruiting |
| Centre Jean Perrin | Clermont-Ferrand | Auvergne-Rhône | Recruiting |
| Timone Hospital - AP-HM | Marseille | Bordeaux | Recruiting |
| Hopital Europeen Geroges Pompidou AP-HP | Paris | Île-de-France Region | Recruiting |
| IRCCS Ospedale San Raffaele | Milan | Lombardy | Recruiting |
| Humanitas Cancer Center | Pieve Emanuele | Milan | Recruiting |
| Istituto Europeo di Oncologia | Milan | Italy | Recruiting |
| Hospital Universitario Virgen del Rocio | Seville | Andalusia | Recruiting |
| Hospital Clinic | Barcelona | Catalonia | Recruiting |
| Complejo Hospitalario Universitario de a Coruna | A Coruña | Galicia | Recruiting |
| Hospital Universitario de Navarra | Pamplona | Navarre | Recruiting |
| Centro Oncologico de Galicia | A Coruña | Spain | Recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Recruiting |
| Hospital Universitario Miguel Servet | Zaragoza | Spain | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06769698 on ClinicalTrials.gov ↗ ← All trials in Australia