NCT07195734View on ClinicalTrials.gov

Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

November 14, 2025

Primary Completion Date

February 1, 2033

Study Completion Date

February 1, 2033

Conditions
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Locally Recurrent Head and Neck Squamous Cell CarcinomaLocally Recurrent Hypopharyngeal Squamous Cell CarcinomaLocally Recurrent Laryngeal Squamous Cell CarcinomaLocally Recurrent Oral Cavity Squamous Cell CarcinomaLocally Recurrent Oropharyngeal Squamous Cell CarcinomaStage II Laryngeal Cancer AJCC v8Stage II Lip and Oral Cavity Cancer AJCC v8Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage III Laryngeal Cancer AJCC v8Stage III Lip and Oral Cavity Cancer AJCC v8Stage IVA Laryngeal Cancer AJCC v8Stage IVA Lip and Oral Cavity Cancer AJCC v8Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVB Laryngeal Cancer AJCC v8Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Carboplatin

Given IV

BIOLOGICAL

Cemiplimab

Given IV

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Paclitaxel

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET scan

RADIATION

Radiation Therapy

Undergo radiation therapy

PROCEDURE

Salvage Surgery

Undergo standard of care salvage surgery

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH