Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Summary

This phase II trial studies the effect of cemiplimab in combination with low-dose paclitaxel and carboplatin in treating patients with squamous cell carcinoma of the head and neck that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as cemiplimab , may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, like paclitaxel and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cemiplimab in combination with paclitaxel and carboplatin may work better in treating recurrent or metastatic squamous cell carcinoma of the head and neck.

Conditions

• Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• 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
• Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Recurrent Head and Neck Squamous Cell Carcinoma
• Recurrent Hypopharyngeal Squamous Cell Carcinoma
• Recurrent Laryngeal Squamous Cell Carcinoma
• Recurrent Oral Cavity Squamous Cell Carcinoma
• Recurrent Oropharyngeal Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Unknown Primary
• Stage IV Hypopharyngeal Carcinoma AJCC v8
• Stage IV Laryngeal Cancer AJCC v8
• Stage IV Lip and Oral Cavity Cancer AJCC v8
• Stage IVA Hypopharyngeal Carcinoma AJCC v8
• Stage IVA Laryngeal Cancer AJCC v8
• Stage IVA Lip and Oral Cavity Cancer AJCC v8
• Stage IVB Hypopharyngeal Carcinoma AJCC v8
• Stage IVB Laryngeal Cancer AJCC v8
• Stage IVB Lip and Oral Cavity Cancer AJCC v8
• Stage IVC Hypopharyngeal Carcinoma AJCC v8
• Stage IVC Laryngeal Cancer AJCC v8
• Stage IVC Lip and Oral Cavity Cancer AJCC v8

Interventions

DRUG

Carboplatin

Given IV

BIOLOGICAL

Cemiplimab

Given IV

DRUG

Paclitaxel

Given IV

Sponsors & Collaborators

• Marcelo Bonomi

  lead OTHER

Principal Investigators

• Marcelo R Bonomi, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-30

Primary Completion

2026-05-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations