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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

NCT07346196•University of Chicago

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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).
+20 more criteria

Exclusion Criteria

•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).
•Exclusions related to infection or immunodeficiency
•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.
+32 more criteria

Locations (1)

The University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

Key Dates

Start Date

February 7, 2027

Primary Completion Date

August 22, 2031

Completion Date

August 22, 2031

Last Updated

January 20, 2026

Enrollment

ESTIMATED participants

Conditions

Squamous Cell Carcinoma

Interventions

Cemiplimab

DRUG

Fianlimab

DRUG

Carboplatin

DRUG

Paclitaxel

DRUG

Radiation

RADIATION

Contacts

Clinical Trials Intake

CONTACT

855-702-8222 cancerclinicaltrials@bsd.uchicago.edu

Ari Rosenberg

CONTACT

arirosenberg@bsd.uchicago.edu

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

NCT04929028

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RECRUITINGPHASE2

Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System

NCT07042295

Locally Recurrent Skin Squamous Cell CarcinomaMetastatic Skin Squamous Cell Carcinoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck

Inclusion Criteria

Exclusion Criteria

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

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