Actively Recruiting
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
Led by Regeneron Pharmaceuticals · Updated on 2026-05-06
120
Participants Needed
10
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that cannot be cured with local treatments
- Primary tumor located in the oral cavity, oropharynx, larynx, or hypopharynx
- PD-L1 expression Combined Positive Score (CPS) of 1 or greater documented before screening
- For oropharynx cancer, HPV status documented from biopsy before screening
- At least one measurable lesion by RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function as outlined in the study protocol
You will not qualify if you...
- Progressive disease within 6 months after completing curative systemic treatment for locoregionally advanced HNSCC
- Primary tumor site in the nasopharynx, paranasal sinus, or salivary gland
- Head and neck squamous cell carcinoma with unknown primary site
- Active, known, or suspected autoimmune disease requiring systemic therapy within 5 years
- History of interstitial lung disease or active noninfectious pneumonitis requiring immunosuppressive steroids
- Significant cardiovascular disease including myocarditis, congestive heart failure (NYHA class III or IV), unstable angina, serious arrhythmia, or recent myocardial infarction within 6 months
- Prior systemic anticancer therapy for recurrent or metastatic HNSCC
- Need for corticosteroid therapy greater than 10 mg prednisone (or equivalent) daily within 14 days before first study drug dose
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
2
Emory University School of Medicine
Atlanta, Georgia, United States, 30308
Actively Recruiting
3
St. Elizabeth Healthcare
Edgewood, Kentucky, United States, 41017
Actively Recruiting
4
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
Actively Recruiting
5
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
6
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
7
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
8
Joe Arrington Cancer Research & Treatment Center
Lubbock, Texas, United States, 79410
Actively Recruiting
9
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Actively Recruiting
10
Peter MacCallum Cancer Centre (PMCC)
Melbourne, Victoria, Australia, 3050
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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