NCT04722523

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

A Pilot Study of Neoadjuvant Cemiplimab With Platinum-Doublet Chemotherapy, and Cetuximab in Patients With Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-01-20
• Primary completion: 2026-06-20
• Completion: 2026-06-20
• First posted: 2021-01-25
• Last updated: 2026-03-30

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study