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 (NCT06769698)
Phase II Randomized Study of Fianlimab Plus Cemiplimab Versus Cemiplimab Plus Placebo in First-Line Treatment of Participants With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That Is Positive for PD-L1 Expression
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: University of California Los Angeles — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (35 Sites)
Showing the first 25 of 35 sites.
- University of California Los Angeles — Los Angeles, California
- Samuel Oschin Cancer Center — Los Angeles, California
- Orlando Health — Orlando, Florida
- Emory University School of Medicine — Atlanta, Georgia
- Northwestern University — Evanston, Illinois
- St. Elizabeth Healthcare — Edgewood, Kentucky
- Norton Cancer Institute — Louisville, Kentucky
- Henry Ford Cancer Institute/Henry Ford Health System — Detroit, Michigan
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists — Omaha, Nebraska
- University of Rochester — Rochester, New York
- Ohio State University — Columbus, Ohio
- Asplundh Cancer Pavilion — Willow Grove, Pennsylvania
- University of Tennessee Medical Center — Knoxville, Tennessee
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee
- Joe Arrington Cancer Research & Treatment Center — Lubbock, Texas
- Renovatio Clinical — The Woodlands, Texas
- Inova Schar Cancer Institute — Fairfax, Virginia
- Virginia Commonwealth University Massey Cancer Center — Richmond, Virginia
- Wide Bay Hospital and Health Service - Cancer Care Services - Bundaberg — Bundaberg, Queensland
- Cairns Hospital — Cairns, Queensland
- Wide Bay Hospital and Health Service — Hervey Bay, Queensland
- Peter MacCallum Cancer Centre (PMCC) — Melbourne, Victoria
- Centre Jean Perrin — Clermont-Ferrand, Auvergne-Rhône
- Timone Hospital - AP-HM — Marseille, Bordeaux
- Hopital Europeen Geroges Pompidou AP-HP — Paris, Île-de-France Region
📞 Contact the Study Coordinator
Phone: (844) 734-6643
Email: clinicaltrials@regeneron.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Head and Neck Squamous Cell Carcinoma (HNSCC)
- [18F]-AraG PET Imaging in LA HNSCC — Indianapolis, Indiana
- Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors — Los Angeles, California
- SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma — Tucson, Arizona
- INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC — Duarte, California
- Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer — Pittsburgh, Pennsylvania
Explore by condition: All Head and Neck Squamous Cell Carcinoma (HNSCC) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.