Actively Recruiting
A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-30
40
Participants Needed
7
Research Sites
282 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to find out whether combining the standard chemotherapy for head and neck cancer with the immunotherapy drugs cetuximab and cemiplimab (the study drug) is a safe treatment for head and neck cancer, and whether receiving this combination treatment before surgery may allow participants to forgo the standard radiation treatment after surgery.
CONDITIONS
Official Title
A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed squamous cell carcinoma of the head and neck from oral cavity, oropharynx, nasal cavity, paranasal sinuses, larynx, or hypopharynx
- Clinical stage T1, N2-3; T2, N1-3; T3/T4a, any N without distant metastasis (M0) suitable for surgery with adjuvant radiation +/- chemotherapy
- Surgically resectable disease
- Patient must be a surgical candidate
- Hemoglobin greater than 9.0 g/dL
- Absolute neutrophil count above 1.5 x 10^9/L
- Platelet count above 100 x 10^9/L
- Serum creatinine less than 1.5 times upper limit of normal or creatinine clearance over 30 mL/min
- Adequate liver function: total bilirubin less than 1.5 times upper limit of normal (or less than 3 times if Gilbert syndrome), AST and ALT less than 3 times upper limit of normal, alkaline phosphatase less than 2.5 times upper limit of normal
- Men and women 18 years or older
- Eastern Cooperative Oncology Group performance status less than 1
You will not qualify if you...
- Prior radiation or systemic therapy for head and neck cancer
- Oral cavity cancer that cannot be surgically removed or patient is not a surgical candidate
- Active or treated autoimmune or inflammatory disorders requiring steroids or immunomodulators in past 5 years, except specific controlled conditions
- Use of systemic corticosteroids over 10 mg prednisone daily or other immunosuppressants within 14 days before study treatment
- Received live attenuated vaccine within 30 days before study treatment
- Prior allogeneic or autologous stem cell transplantation
- Infection requiring hospitalization or IV antibiotics within 2 weeks before treatment
- Uncontrolled HIV, hepatitis B or C infection, or immunodeficiency
- History of immune-related pneumonitis within 5 years
- History of interstitial lung disease or active noninfectious pneumonitis requiring immunosuppressive steroids
- Allergy to cemiplimab or its ingredients
- History of solid organ transplant except corneal transplant
- Any medical condition or lab abnormality posing high safety risk
- Positive pregnancy test or breastfeeding
- Women of childbearing potential unwilling to use effective contraception before, during, and for 180 days after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
L
Lara Dunn, MD
CONTACT
D
David Pfister, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here