NCT06980038View on ClinicalTrials.gov

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

May 1, 2027

Study Completion Date

May 1, 2027

Conditions
Recurrent Head and Neck Cutaneous Squamous Cell CarcinomaRecurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaStage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage III Laryngeal Cancer AJCC v8Stage III Lip and Oral Cavity Cancer AJCC v8Stage III Nasopharyngeal Carcinoma AJCC v8Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage IVA Laryngeal Cancer AJCC v8Stage IVA Lip and Oral Cavity Cancer AJCC v8Stage IVA Nasopharyngeal Carcinoma AJCC v8Stage IVB Laryngeal Cancer AJCC v8Stage IVB Lip and Oral Cavity Cancer AJCC v8
Interventions
BIOLOGICAL

Anti-CD40 Agonist Monoclonal Antibody CDX-1140

Given IV

PROCEDURE

Biopsy Procedure

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

BIOLOGICAL

Cemiplimab

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

PROCEDURE

Positron Emission Tomography

Undergo PET scan

PROCEDURE

Tumor Resection

Undergo resection surgery

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH