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Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma | Clinical Trials | Clareo Health

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Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma

Immunotherapy With MK-3475 in Locoregionally Advanced, Surgically Resectable Head and Neck Squamous Cell Carcinoma

NCT02296684•Washington University School of Medicine

View on ClinicalTrials.gov

Summary

The goal of this trial is to test the ability of MK-3475 (pembrolizumab) to improve locoregional recurrence and distant metastatic rates in high-risk patients with locally advanced head and neck squamous cell carcinomas (HNSCCs) that are treated with current standard of care surgical approaches.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed stage III or IV HNSCC oral cavity, hypopharynx, oropharynx, larynx (excluding p16 or HPV-positive oropharynx primaries and sinonasal primaries).
•Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>10 mm with CT scan, as \>20 mm by chest x-ray, or \>10 mm with calipers by clinical exam by RECIST 1.1.
•At least 18 years of age.
•ECOG performance status ≤ 1
•Normal bone marrow and organ function as defined below:
•* Absolute neutrophil count ≥ 1,500/mcl
•* Platelets ≥ 100,000/mcl
•* Hemoglobin ≥ 9 g/dL
•* Total bilirubin ≤ 1.5 x IULN OR Direct bilirubin ≤ IULN for patients with total bilirubin \> 1.5 x IULN
•* AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN (or ≤ 5 x IULN for patients with liver metastases)
+5 more criteria

Exclusion Criteria

•Prior treatment for head and neck cancer.
•Patients with HPV-positive or p16-positive oropharyngeal SCCA.
•Patients with sinonasal SCCAs
•Patients with metastatic SCCA neck disease with an unknown primary tumor site
•Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
•Received a live vaccine within 30 days prior to the first dose of MK-3475. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated viruses and are not allowed.
•A history of other malignancy ≤ 3 years previous with the exception of previous head and neck cancer treated only by surgery, basal cell or squamous cell carcinoma of the skin which were treated with local resection only, or carcinoma in situ of the cervix.
•Note: patients with synchronous head and neck cancer primaries are an exception to this criterion and may qualify for the study.
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of MK-3475.
•Currently receiving any other investigational agents or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of MK-3475.
+8 more criteria

Locations (3)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

March 25, 2015

Primary Completion Date

April 5, 2022

Completion Date

July 21, 2025

Last Updated

January 15, 2026

Enrollment

ACTUAL participants

Conditions

Cancer of Head and NeckHead and Neck CancerNeoplasms, Head and NeckCarcinoma, Squamous Cell of Head and NeckSquamous Cell Carcinoma of the Head and NeckSquamous Cell Carcinoma, Head and Neck

Interventions

MK-3475 (neoadjuvant)

BIOLOGICAL

Surgery

PROCEDURE

Intensity modulated radiation therapy

RADIATION

Image-guided radiation therapy

RADIATION

Cisplatin

DRUG

MK-3475 (adjuvant)

BIOLOGICAL

Peripheral blood

PROCEDURE

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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 15, 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

Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

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