A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck
A Randomized Phase II Trial of Induction Cemiplimab Plus Chemotherapy With or Without Fianlimab in Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck
1 other identifier
interventional
90
1 country
1
Brief Summary
The goal of this clinical trial is to learn if the combination of cemiplimab and fianlimab can improve outcomes compared to cemiplimab alone in adults with Human Papillomavirus Positive HPV-positive head and neck cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2027
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2026
CompletedFirst Posted
Study publicly available on registry
January 16, 2026
CompletedStudy Start
First participant enrolled
February 7, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2031
Study Completion
Last participant's last visit for all outcomes
August 22, 2031
January 20, 2026
January 1, 2026
4.5 years
January 14, 2026
January 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
To assess the overall response rate (ORR) of induction cemiplimab and chemotherapy, with or without fianlimab in patients with locoregionally advanced squamous cell carcinoma of the head and neck. ORR will be measured and compared between the two treatment groups using a pick-the-winner design.
9 weeks
Secondary Outcomes (3)
Assess survival and progression based on RECIST
2 years
Using RECIST to assess disease control
24 months
Assess acute and long-term/late toxicities using RECIST
1 month, 3 months, and 1-year post-chemoradiation
Study Arms (2)
Cemiplimab + chemo
EXPERIMENTALParticipants assigned to this arm will receive Cemiplimab in combination with chemotherapy (paclitaxel and carboplatin) for 3 cycles (9 weeks). This will be followed by Chemoradiation with Cisplatin and Radiotherapy for 7 weeks. Cemiplimab will then be given for an additional 6 months.
Cemiplimab + chemo + fianlimab
EXPERIMENTALParticipants assigned to this arm will receive Cemiplimab and Fianlimab in combination with chemotherapy (paclitaxel and carboplatin) for 3 cycles (9 weeks). This will be followed by Chemoradiation with Cisplatin and Radiotherapy for 7 weeks. Cemiplimab will then be given for an additional 6 months.
Interventions
Radiotherapy will be delivered to a total dose of 70 Gy.
Eligibility Criteria
You may qualify if:
- Newly diagnosed, pathologically proven, treatment-naïve unresected LA-HNSCC
- Stage T3-T4 \[N0-N3\] or any N2a-3 \[T1-T4\] larynx, hypopharynx, oral cavity, or p16(-) oropharynx (AJCC 8th edition staging)
- Stage T4 or N3 p16(+) oropharynx (AJCC 8th edition staging)
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. RECIST 1.1 criteria
- No previous radiation or chemotherapy for head and neck cancer.
- No complete surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy/excision of the tumor with residual measurable disease is acceptable.)
- If a primary oropharyngeal squamous cell carcinoma is diagnosed, HPV status must be assessed by immunohistochemistry for p16 expression prior to enrollment. Confirmatory HPV assessment with HPV ISH or HPV PCR should also be completed, however, this is not required for enrollment.
- Patients must be at least 18 years of age. Because no dosing or adverse event data are currently available on the use of Cemiplimab in combination with Fianlimab in patients \<18 years of age, children are excluded from this study.
- ECOG performance status 0-1
- Patients must have adequate organ and marrow function as defined below).
- Leukocytes ≥3,000/mcL
- Absolute neutrophil count ≥1,500/mcL
- Platelets ≥100,000/mcL
- Hemoglobin ≥ 9.0 gm/dL
- Total bilirubin within normal institutional limits
- +16 more criteria
You may not qualify if:
- Unequivocal demonstration of distant metastatic disease (M1 disease).
- Unidentifiable primary site.
- Patients who are receiving any other investigational agents.
- Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment as discussed above.
- Prior systemic anti-cancer treatment within the last 8 weeks.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or any tumors that are not likely to influence life expectancy in the subsequent 3 years without active treatment. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
- Active medical illness(es) which would impair patient tolerance to therapy or limit survival. This includes but is not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance. Patients with clinically stable and/or chronically managed medical illnesses that are not symptomatic and/or are not expected to impact treatment on protocol are still eligible (conditions to be reviewed by the PI to confirm eligibility).
- History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (eg, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.
- Active infection requiring therapy.
- Uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.
- Patients with known HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.
- Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.
- Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.
- Patients with HIV or hepatitis must be reviewed by a qualified specialist (eg, infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ari arirosenberg@bsd.uchicago.edu
University of Chicago
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2026
First Posted
January 16, 2026
Study Start (Estimated)
February 7, 2027
Primary Completion (Estimated)
August 22, 2031
Study Completion (Estimated)
August 22, 2031
Last Updated
January 20, 2026
Record last verified: 2026-01