A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer

Summary

The purpose of this study is to find out whether combining the standard chemotherapy for head and neck cancer with the immunotherapy drugs cetuximab and cemiplimab (the study drug) is a safe treatment for head and neck cancer, and whether receiving this combination treatment before surgery may allow participants to forgo the standard radiation treatment after surgery.

Conditions

• Head and Neck Cancer
• Head Cancer
• Head Cancer Neck
• Neck Cancer
• Head and Neck Squamous Cell Carcinoma
• HNSCC

Interventions

DRUG

Cisplatin

Cisplatin 75mg/m2 AUC 5 on weeks 2, 5, and 8

DRUG

Carboplatin

Carboplatin AUC 5 on weeks 2, 5, and 8

DRUG

Docetaxel

Docetaxel 75mg/m2 on weeks 2, 5, and 8

DRUG

Cetuximab

Cetuximab 400mg/m2 on week 1, 250mg/m2 on weeks 2, 3, 4, 5, 6, 7, 8, 9, 10

DRUG

Cemiplimab

Cemiplimab 350mg on weeks 2, 5, 8, 11; if adjuvant radiation +/- chemotherapy is omitted, Cemiplimab will be administered on weeks 16, 19, 22, 25, 28, 31, 34, 37

PROCEDURE

Surgical Resection of Primary +/- Neck Dissection

Twenty-eight days (+ 7 days) following the 3rd cycle of neoadjuvant therapy, patients will then undergo definitive surgical resection of the primary site +/- neck dissection(s).

RADIATION

Post-operative radiation therapy

Post-operative radiation therapy +/- radiosensitizing agent(s) will be administered per standard-of-care based on pathologic staging of the surgical specimen. If there is an excellent response to treatment with a high degree of downstaging the addition of adjuvant radiation may be omitted if NCCN guidelines are met. If the pathologic stage following induction systemic therapy and surgery is ypT1-2N0 without the presence of adverse features that include positive margins or a combination of perineural invasion, vascular invasion, and a depth of invasion of \>0.5mm, adjuvant radiation will not be administered, consistent with the NCCN guidelines \[2\]. Otherwise, patients will receive adjuvant RT-based treatment with standard radiation techniques.

DRUG

Paclitaxel

If participants are unable to receive Docetaxel due to lack of insurance approval or due to an allergic reaction, Docetaxel can be substituted with Paclitaxel. Paclitaxel would be dosed at 90 mg/m2 on weeks 2, 3, 5, 6, 8 and 9.

Sponsors & Collaborators

• Regeneron Pharmaceuticals

  collaborator INDUSTRY

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Lara Dunn, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-20

Primary Completion

2026-06-20

Completion

2026-06-20

FDA Drug

Yes

Countries

• United States

Study Locations