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

NCT07195734 · clinicaltrials.gov ↗

PHASE2

Phase

RECRUITING

Status

180

Enrollment

NIH

Sponsor class

Conditions

Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Locally Recurrent Head and Neck Squamous Cell Carcinoma
Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma
Locally Recurrent Laryngeal Squamous Cell Carcinoma
Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Locally Recurrent Oropharyngeal Squamous Cell Carcinoma
Stage II Laryngeal Cancer AJCC v8
Stage II Lip and Oral Cavity Cancer AJCC v8
Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage III Laryngeal Cancer AJCC v8
Stage III Lip and Oral Cavity Cancer AJCC v8
Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage IVA Laryngeal Cancer AJCC v8
Stage IVA Lip and Oral Cavity Cancer AJCC v8
Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage IVB Laryngeal Cancer AJCC v8
Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Interventions

PROCEDURE: Biospecimen Collection
DRUG: Carboplatin
BIOLOGICAL: Cemiplimab
DRUG: Cisplatin
PROCEDURE: Computed Tomography
DRUG: Paclitaxel
PROCEDURE: Positron Emission Tomography
RADIATION: Radiation Therapy
PROCEDURE: Salvage Surgery

Sponsor

National Cancer Institute (NCI)