Actively Recruiting
Phase II Randomized Study of Fianlimab Plus Cemiplimab Versus Cemiplimab Plus Placebo in First-Line Treatment of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Positive for PD-L1 Expression
Led by Regeneron Pharmaceuticals · Updated on 2026-05-06
120
Participants Needed
10
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an experimental drug called fianlimab (REGN3767) combined with cemiplimab compared to cemiplimab with a placebo in participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who have not received prior treatment for their advanced cancer. The study also explores side effects, drug levels in the blood, and whether the body develops antibodies against the study drugs, aiming to improve understanding of these treatments and the disease. Participants are divided into two groups based on HPV status: one group with HPV-positive HNSCC and another with HPV-negative HNSCC. Each group is randomly assigned to receive either the fixed-dose combination of fianlimab and cemiplimab or cemiplimab with placebo. Treatments are given according to a defined protocol, and participants are followed for outcomes related to response and safety. During the study, researchers will monitor participants for overall response rate up to 90 days after the last treatment and for about 58 months. They will track a range of safety measures including adverse events and immune responses. Drug concentrations and antibody formation against fianlimab will also be measured. This long-term follow-up helps assess how participants respond and tolerate the study drugs over time.
CONDITIONS
Brief 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 considered incurable by local therapies
- Primary tumor located in oral cavity, oropharynx, larynx, or hypopharynx or cervical neck node SCC with occult primary
- PD-L1 expression combined positive score (CPS) of 1 or higher documented before screening
- For oropharynx cancer, documented HPV status from biopsy specimen prior to 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 described in the protocol
You will not qualify if you...
- Progressive disease within 6 months after curative systemic treatment for locoregionally advanced HNSCC
- Primary tumor site of 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 glucocorticoids
- Significant cardiovascular disease including myocarditis, severe heart failure, unstable angina, serious arrhythmia, or recent myocardial infarction
- Prior systemic anticancer therapy in the recurrent or metastatic HNSCC setting
- Requirement for corticosteroid therapy above specified dose within 14 days of first study drug dose
- Additional protocol-defined inclusion and exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 58 months including treatment and follow-up
Participants receive either the combination of Fianlimab and Cemiplimab or Cemiplimab with placebo as first-line treatment for their recurrent or metastatic head and neck squamous cell carcinoma.
Visits occur regularly as per protocol during treatment
Duration - Up to 90 days after last study treatment
Participants are monitored for safety and treatment outcomes after completing the study treatment.
Visits occur for up to 3 months after treatment ends
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
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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