RecruitingPhase 1NCT04722523

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

40 participants

Start Date

Jan 20, 2021

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding an immunotherapy drug called cemiplimab before and after surgery improves outcomes for patients with head and neck squamous cell cancer — cancers of the mouth, throat, voice box, or related areas that can be surgically removed. **You may be eligible if:** - You are over 18 years old - You have been diagnosed with squamous cell cancer of the head or neck (oral cavity, throat, voice box, sinuses, or related areas) - Your cancer has not spread to distant organs and is considered surgically removable - You have adequate blood counts, kidney function, and liver function **You may NOT be eligible if:** - You have had prior radiation or systemic treatment for a head and neck cancer - You have an active autoimmune disease that has required steroid or immunosuppressant therapy in the past 5 years - You have received a live vaccine recently or are on high-dose steroids - You have had a stem cell transplant or solid organ transplant - You have uncontrolled HIV, hepatitis B, or hepatitis C - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCisplatin

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

DRUGCarboplatin

Carboplatin AUC 5 on weeks 2, 5, and 8

DRUGDocetaxel

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

DRUGCetuximab

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

DRUGCemiplimab

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

PROCEDURESurgical 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).

RADIATIONPost-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.

DRUGPaclitaxel

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.