Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment

Summary

This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and/or metastatic HNSCC than pembrolizumab alone.

Conditions

• Metastatic Head and Neck Squamous Cell Carcinoma
• Metastatic Hypopharyngeal Squamous Cell Carcinoma
• Metastatic Laryngeal Squamous Cell Carcinoma
• Metastatic Oral Cavity Squamous Cell Carcinoma
• Metastatic Oropharyngeal Squamous Cell Carcinoma
• Recurrent Head and Neck Squamous Cell Carcinoma
• Recurrent Hypopharyngeal Squamous Cell Carcinoma
• Recurrent Laryngeal Squamous Cell Carcinoma
• Recurrent Neck Squamous Cell Carcinoma of Unknown Primary
• Recurrent Oral Cavity Squamous Cell Carcinoma
• Recurrent Oropharyngeal Squamous Cell Carcinoma
• Refractory Head and Neck Squamous Cell Carcinoma
• Refractory Hypopharyngeal Squamous Cell Carcinoma
• Refractory Laryngeal Squamous Cell Carcinoma
• Refractory Oral Cavity Squamous Cell Carcinoma
• Refractory Oropharyngeal Squamous Cell Carcinoma
• Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
• Stage IV Hypopharyngeal Carcinoma AJCC v8
• Stage IV Laryngeal Cancer AJCC v8
• Stage IV Lip and Oral Cavity Cancer AJCC v8
• Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

BIOLOGICAL

Cetuximab

Given IV

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Siddharth Sheth · Alliance for Clinical Trials in Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-27

Primary Completion

2029-11-30

Completion

2029-11-30

FDA Drug

Yes

Countries

• United States

Study Locations