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
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Head and Neck Squamous Cell Carcinoma (HNSCC)
In brief
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
Key facts
- Study ID
- NCT06769698
- Run by
- Regeneron Pharmaceuticals
- People needed
- 120
- Starts
- 2026-04-14
- Expected to finish
- 2030-12-28
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California Los Angeles — Los Angeles, California, United States (enrolling)
- Samuel Oschin Cancer Center — Los Angeles, California, United States (enrolling)
- Orlando Health — Orlando, Florida, United States (enrolling)
- Emory University School of Medicine — Atlanta, Georgia, United States (enrolling)
- Northwestern University — Evanston, Illinois, United States (enrolling)
- St. Elizabeth Healthcare — Edgewood, Kentucky, United States (enrolling)
- Norton Cancer Institute — Louisville, Kentucky, United States (enrolling)
- Henry Ford Cancer Institute/Henry Ford Health System — Detroit, Michigan, United States (enrolling)
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
- University of Rochester — Rochester, New York, United States (enrolling)
- Ohio State University — Columbus, Ohio, United States (enrolling)
- Asplundh Cancer Pavilion — Willow Grove, Pennsylvania, United States (enrolling)
- University of Tennessee Medical Center — Knoxville, Tennessee, United States (enrolling)
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States (enrolling)
- Joe Arrington Cancer Research & Treatment Center — Lubbock, Texas, United States (enrolling)
- Renovatio Clinical — The Woodlands, Texas, United States (enrolling)
- Inova Schar Cancer Institute — Fairfax, Virginia, United States (enrolling)
- Wide Bay Hospital and Health Service - Cancer Care Services - Bundaberg — Bundaberg, Queensland, Australia (enrolling)
- Cairns Hospital — Cairns, Queensland, Australia (enrolling)
- Wide Bay Hospital and Health Service — Hervey Bay, Queensland, Australia (enrolling)
- Peter MacCallum Cancer Centre (PMCC) — Melbourne, Victoria, Australia (enrolling)
- Centre Jean Perrin — Clermont-Ferrand, Auvergne-Rhône, France (enrolling)
- Timone Hospital - AP-HM — Marseille, Bordeaux, France (enrolling)
- Hopital Europeen Geroges Pompidou AP-HP — Paris, Île-de-France Region, France (enrolling)
- Istituto Europeo di Oncologia — Milan, Italy (enrolling)
Full record on ClinicalTrials.gov
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