🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Australia / NCT06769698
Recruiting Phase 2

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 · tracked via the Priya Life Science Australia tracker
Phase
Phase 2
Started
2026-04-14
Last updated
2026-08-21

Condition(s) studied

Head and Neck Squamous Cell Carcinoma (HNSCC)

Investigational drug(s) / intervention(s)

FDC fianlimab+cemiplimab →Cemiplimab →Placebo

FDC fianlimab+cemiplimab: Fixed-Dose Combination (FDC) Administered per the protocol

Cemiplimab: Administered per the protocol

Placebo: Administered per the protocol

Study 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.

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (35)

FacilityCityRegionStatus
University of California Los Angeles Los Angeles California Recruiting
Samuel Oschin Cancer Center Los Angeles California Recruiting
Orlando Health Orlando Florida Recruiting
Emory University School of Medicine Atlanta Georgia Recruiting
Northwestern University Evanston Illinois Recruiting
St. Elizabeth Healthcare Edgewood Kentucky Recruiting
Norton Cancer Institute Louisville Kentucky Recruiting
Henry Ford Cancer Institute/Henry Ford Health System Detroit Michigan Recruiting
Oncology Hematology West P.C. dba Nebraska Cancer Specialists Omaha Nebraska Recruiting
University of Rochester Rochester New York Recruiting
Ohio State University Columbus Ohio Recruiting
Asplundh Cancer Pavilion Willow Grove Pennsylvania Recruiting
University of Tennessee Medical Center Knoxville Tennessee Recruiting
Vanderbilt-Ingram Cancer Center Nashville Tennessee Recruiting
Joe Arrington Cancer Research & Treatment Center Lubbock Texas Recruiting
Renovatio Clinical The Woodlands Texas Recruiting
Inova Schar Cancer Institute Fairfax Virginia Recruiting
Virginia Commonwealth University Massey Cancer Center Richmond Virginia Recruiting
Wide Bay Hospital and Health Service - Cancer Care Services - Bundaberg Bundaberg Queensland Recruiting
Cairns Hospital Cairns Queensland Recruiting
Wide Bay Hospital and Health Service Hervey Bay Queensland Recruiting
Peter MacCallum Cancer Centre (PMCC) Melbourne Victoria Recruiting
Centre Jean Perrin Clermont-Ferrand Auvergne-Rhône Recruiting
Timone Hospital - AP-HM Marseille Bordeaux Recruiting
Hopital Europeen Geroges Pompidou AP-HP Paris Île-de-France Region Recruiting
IRCCS Ospedale San Raffaele Milan Lombardy Recruiting
Humanitas Cancer Center Pieve Emanuele Milan Recruiting
Istituto Europeo di Oncologia Milan Italy Recruiting
Hospital Universitario Virgen del Rocio Seville Andalusia Recruiting
Hospital Clinic Barcelona Catalonia Recruiting
Complejo Hospitalario Universitario de a Coruna A Coruña Galicia Recruiting
Hospital Universitario de Navarra Pamplona Navarre Recruiting
Centro Oncologico de Galicia A Coruña Spain Recruiting
Hospital Universitario La Paz Madrid Spain Recruiting
Hospital Universitario Miguel Servet Zaragoza Spain Recruiting

On this site

📄 Libtayo (cemiplimab) drug profile →

More Regeneron Pharmaceuticals trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06769698 on ClinicalTrials.gov ↗ ← All trials in Australia