New drug duo aims to fight recurrent head and neck cancer

NCT ID NCT06769698

Recruiting now Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 6 times

Summary

This Phase 2 trial tests whether adding fianlimab to cemiplimab works better than cemiplimab alone for people with advanced head and neck cancer that has come back or spread. About 120 participants whose tumors have a specific marker (PD-L1 positive) will receive either the drug combination or cemiplimab plus a placebo. The study will measure tumor shrinkage and track side effects.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: fianlimab and cemiplimab (immune-boosting drugs)
What this could lead to: If it works, this combination could offer a more effective first-line treatment for people with advanced head and neck cancer that has spread or come back.
What could go wrong: This is a Phase 2 trial with only 120 participants, so results are preliminary. The drug combination may cause immune-related side effects, and it may not improve outcomes compared to standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Neoplasm Metastasis Recurrence Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC)

Contacts and locations

Locations

Asplundh Cancer Pavilion
RECRUITING

Willow Grove, Pennsylvania, 19090, United States
Cairns Hospital
RECRUITING

Cairns, Queensland, 4870, Australia
Centre Jean Perrin
RECRUITING

Clermont-Ferrand, Auvergne-Rhône, 63011, France
Centro Oncologico de Galicia
RECRUITING

A Coruña, 15009, Spain
Complejo Hospitalario Universitario de a Coruna
RECRUITING

A Coruña, Galicia, 15006, Spain
Emory University School of Medicine
RECRUITING

Atlanta, Georgia, 30308, United States
Henry Ford Cancer Institute/Henry Ford Health System
RECRUITING

Detroit, Michigan, 48202, United States
Hopital Europeen Geroges Pompidou AP-HP
RECRUITING

Paris, Île-de-France Region, 75015, France
Hospital Clinic
RECRUITING

Barcelona, Catalonia, 08036, Spain
Hospital Universitario La Paz
RECRUITING

Madrid, 28046, Spain
Hospital Universitario Miguel Servet
RECRUITING

Zaragoza, 50009, Spain
Hospital Universitario Virgen del Rocio
RECRUITING

Seville, Andalusia, 41013, Spain
Hospital Universitario de Navarra
RECRUITING

Pamplona, Navarre, 31008, Spain
Inova Schar Cancer Institute
RECRUITING

Fairfax, Virginia, 22031, United States
Istituto Europeo di Oncologia
RECRUITING

Milan, 20141, Italy
Joe Arrington Cancer Research & Treatment Center
RECRUITING

Lubbock, Texas, 79410, United States
Northwestern University
RECRUITING

Evanston, Illinois, 60208, United States
Norton Cancer Institute
RECRUITING

Louisville, Kentucky, 40202, United States
Ohio State University
RECRUITING

Columbus, Ohio, 43210, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
RECRUITING

Omaha, Nebraska, 68130, United States
Orlando Health
RECRUITING

Orlando, Florida, 32806, United States
Peter MacCallum Cancer Centre (PMCC)
RECRUITING

Melbourne, Victoria, 3050, Australia
Renovatio Clinical
RECRUITING

The Woodlands, Texas, 77380, United States
Samuel Oschin Cancer Center
RECRUITING

Los Angeles, California, 90048, United States
St. Elizabeth Healthcare
RECRUITING

Edgewood, Kentucky, 41017, United States
Timone Hospital - AP-HM
RECRUITING

Marseille, Bordeaux, 13005, France
University of California Los Angeles
RECRUITING

Los Angeles, California, 90024, United States
University of Rochester
RECRUITING

Rochester, New York, 14642, United States
University of Tennessee Medical Center
RECRUITING

Knoxville, Tennessee, 37920, United States
Vanderbilt-Ingram Cancer Center
RECRUITING

Nashville, Tennessee, 37232, United States
Wide Bay Hospital and Health Service
RECRUITING

Hervey Bay, Queensland, 4655, Australia
Wide Bay Hospital and Health Service - Cancer Care Services - Bundaberg
RECRUITING

Bundaberg, Queensland, 4670, Australia

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