Head and Neck Squamous Cell Carcinoma (HNSCC)Phase 2NCT06769698
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
A Phase 2 study testing FDC fianlimab+cemiplimab and Cemiplimab in people with Head and Neck Squamous Cell Carcinoma (HNSCC), run by Regeneron Pharmaceuticals at 38 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- What is being tested?
- FDC fianlimab+cemiplimab and Cemiplimab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 38 sitesin 6 countries
- Study dates
- 14 Apr 2026to 28 Dec 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have histologically confirmed (by local pathology) R/M HNSCC that is considered incurable by local therapies
- Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx (patients with cervical neck node SCC with occult primary as described in the protocol
- 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
- 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
- At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as described in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function as described in the protocol
Who cannot join
- Medical Conditions
- 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
- Participants who have a primary tumor site of nasopharynx, paranasal sinus or salivary gland (any histology)
- Head and neck SCC with unknown primary site as described in the protocol
- 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
- 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
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- 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
- Participants who have received prior systemic anticancer therapy in the R/M HNSCC setting as described in the protocol
- 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
Trial locations and contacts
38 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
38 sites in 6 countries
United States18 sites, 18 recruiting
- Recruiting
Emory University School of Medicine
Atlanta, Georgia, 30308
- Recruiting
Ohio State University
Columbus, Ohio, 43210
- Recruiting
Henry Ford Cancer Institute/Henry Ford Health System
Detroit, Michigan, 48202
- Recruiting
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017
- Recruiting
Northwestern University
Evanston, Illinois, 60208
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
- Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
- Recruiting
University of California Los Angeles
Los Angeles, California, 90024
- Recruiting
Samuel Oschin Cancer Center
Los Angeles, California, 90048
- Recruiting
Norton Cancer Institute
Louisville, Kentucky, 40202
- Recruiting
Joe Arrington Cancer Research & Treatment Center
Lubbock, Texas, 79410
- Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
- Recruiting
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130
- Recruiting
Orlando Health
Orlando, Florida, 32806
- Recruiting
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
- Recruiting
University of Rochester
Rochester, New York, 14642
- Recruiting
Renovatio Clinical
The Woodlands, Texas, 77380
- Recruiting
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
Spain8 sites, 8 recruiting
- Recruiting
Complejo Hospitalario Universitario de a Coruna
A Coruña, Galicia, 15006
- Recruiting
Centro Oncologico de Galicia
A Coruña, 15009
- Recruiting
Hospital Clinic
Barcelona, Catalonia, 08036
- Recruiting
University Hospital Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
Australia4 sites, 4 recruiting
- Recruiting
Wide Bay Hospital and Health Service - Cancer Care Services - Bundaberg
Bundaberg, Queensland, 4670
- Recruiting
Cairns Hospital
Cairns, Queensland, 4870
- Recruiting
Wide Bay Hospital and Health Service
Hervey Bay, Queensland, 4655
- Recruiting
Peter MacCallum Cancer Centre (PMCC)
Melbourne, Victoria, 3050
Italy4 sites, 4 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132
- Recruiting
Fondazione Irccs Istituto Nazionale dei Tumori di Milano
Milan, Lombardy, 20133
- Recruiting
Istituto Europeo di Oncologia
Milan, 20141
- Recruiting
Humanitas Cancer Center
Pieve Emanuele, Milan, 25123
France3 sites, 3 recruiting
- Recruiting
Centre Jean Perrin
Clermont-Ferrand, Auvergne-Rhône, 63011
- Recruiting
Timone Hospital - AP-HM
Marseille, Bordeaux, 13005
- Recruiting
Hopital Europeen Geroges Pompidou AP-HP
Paris, Île-de-France Region, 75015
Poland1 site, 1 recruiting
- Recruiting
Wojewodzki Szpital im. Sw. Ojca Pio
Przemyśl, Podkarpackie Voivodeship, 37-700
About this study
Official title: 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
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).
Read more
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
- Being tested
- FDC fianlimab+cemiplimab, Cemiplimab, Placebo
- Keywords
- Recurrent or Metastatic (R/M), Positive for Programmed Death Ligand 1 (PD-L1) Expression, Human Papillomavirus (HPV)
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDC fianlimab+cemiplimabDrug
Also called REGN3767, REGN2810, Libtayo
Fixed-Dose Combination (FDC) Administered per the protocol
CemiplimabDrug
Also called R2810, Libtayo
Administered per the protocol
PlaceboDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Approximately 60 participants with HPV (human papillomavirus) positive HNSCC. Randomized 1:1 to Fianlimab + Cemiplmab Fixed Dose Combination (FDC) versus Cemiplimab + Placebo. Receives: Drug: FDC fianlimab+cemiplimab; Drug: Cemiplimab; Drug: Placebo |
| Cohort 2 | Experimental | Approximately 60 participants with HPV negative HNSCC. Randomization is the same as in Cohort 1. Receives: Drug: FDC fianlimab+cemiplimab; Drug: Cemiplimab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Measured: Up to 90 days after last study treatment, approximately 58 months
Secondary outcomes (17)
Incidence of Adverse Events (AEs)
Measured: Up to 90 days after last study treatment, approximately 58 months
Severity of AEs
Measured: Up to 90 days after last study treatment, approximately 58 months
Incidence of Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 90 days after last study treatment, approximately 58 months
Incidence of immune-mediated Adverse Events (imAEs)
Measured: Up to 90 days after last study treatment, approximately 58 months
Incidence of treatment-related AEs
Measured: Up to 90 days after last study treatment, approximately 58 months
Incidence of Adverse Events of Special Interest (AESIs)
Measured: Up to 90 days after last study treatment, approximately 58 months
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 90 days after last study treatment, approximately 58 months
Incidence of AEs leading to discontinuation
Measured: Up to 90 days after last study treatment, approximately 58 months
Incidence of AEs leading to death
Measured: Up to 90 days after last study treatment, approximately 58 months
Incidence of laboratory abnormalities
Per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Measured: Up to 90 days after last study treatment, approximately 58 months
Disease Control Rate (DCR) per investigator assessment
Measured: Up to 90 days after last study treatment, approximately 58 months
Duration of Response (DOR) per investigator assessment or death, whichever occurs first
Measured: Up to 90 days after last study treatment, approximately 58 months
Progression-Free Survival (PFS) per investigator assessment or death, whichever occurs first
Measured: Up to 90 days after last study treatment, approximately 58 months
Concentrations of cemiplimab in serum
Measured: Up to 90 days after last study treatment, approximately 58 months
Concentrations of fianlimab in serum
Measured: Up to 90 days after last study treatment, approximately 58 months
Incidence of Anti-Drug Antibody (ADA) to fianlimab
Measured: Up to 90 days after last study treatment, approximately 58 months
Titer of ADA to fianlimab
Measured: Up to 90 days after last study treatment, approximately 58 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start14 Apr 2026
- Primary completion4 Jun 2028 (estimated)
- Study completion28 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma (HNSCC)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769698
- Sponsor's protocol ID
- R3767-ONC-2431
- Other IDs
- 2024-517620-19-00
- Status last verified
- Oct 2026
- First submitted
- 6 Jan 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing