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New drug duo aims to fight recurrent head and neck cancer

NCT ID NCT06769698

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 7 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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Have histologically confirmed (by local pathology) R/M HNSCC that is considered incurable by local therapies 2. Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx (patients with cervical neck node SCC with occult primary as described in the protocol 3. PD-L1 expression Combined Positive Score (CPS) ≥1 documented with a previously PD-L1 obtained Immunohistochemistry (IHC) result prior to screening, as described in protocol 4. Oropharynx cancer participants only: HPV status, based on a previously documented result prior to screening, must have been established in a surgical biopsy specimen or a core biopsy specimen as described in the protocol 5. At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as described in the protocol 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 7. Adequate organ and bone marrow function as described in the protocol Key Exclusion Criteria: Medical Conditions 1. Participants who have Progressive Disease (PD) within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC as described in the protocol 2. Participants who have a primary tumor site of nasopharynx, paranasal sinus or salivary gland (any histology) 3. Head and neck SCC with unknown primary site as described in the protocol 4. Participants with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date as described in the protocol 5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management 6. History or current evidence of significant cardiovascular disease including, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classification III and IV), unstable angina, serious uncontrolled arrhythmia, and myocardial infarction 6 months prior to study enrollment. Prior/Concomitant Therapy 7. Participants who have received prior systemic anticancer therapy in the R/M HNSCC setting as described in the protocol 8. Participants with a condition requiring corticosteroid therapy (\>10 mg prednisone/prednisolone/day or equivalent) within 14 days of the first dose of study drug as described in the protocol Note: Other protocol defined Inclusion/ Exclusion Criteria apply

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    35 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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

  • Humanitas Cancer Center

    RECRUITING

    Pieve Emanuele, Milan, 25123, Italy

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, Lombardy, 20132, Italy

  • 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

  • Virginia Commonwealth University Massey Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, 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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