New drug duo aims to shrink head and neck tumors

NCT ID NCT06769698

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

First seen Jan 08, 2026 · Last updated Jun 22, 2026 · Updated 24 times

Summary

This Phase 2 trial tests whether adding fianlimab to the standard drug cemiplimab helps shrink tumors in people with advanced head and neck cancer that has spread or come back. About 120 participants whose tumors show a specific marker (PD-L1) will receive either the combo or cemiplimab alone. The study tracks tumor response and side effects.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Emory University School of Medicine
RECRUITING

Atlanta, Georgia, 30308, United States
Inova Schar Cancer Institute
RECRUITING

Fairfax, Virginia, 22031, United States
Joe Arrington Cancer Research & Treatment Center
RECRUITING

Lubbock, Texas, 79410, 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
St. Elizabeth Healthcare
RECRUITING

Edgewood, Kentucky, 41017, United States
Vanderbilt-Ingram Cancer Center
RECRUITING

Nashville, Tennessee, 37232, United States

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 (drug combination)

What this could lead to

If successful, this could offer a new first-line treatment option for people with advanced head and neck cancer that has spread or returned.

What could go wrong

This is an early Phase 2 trial with only 120 participants, so results may not apply to everyone. The drug combination may cause side effects or not work better than the existing treatment.

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 HEAD AND NECK SQUAMOUS CELL CARCINOMA HNSCC