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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cisplatin — DRUG
  Cisplatin 75mg/m2 AUC 5 on weeks 2, 5, and 8
• Carboplatin — DRUG
  Carboplatin AUC 5 on weeks 2, 5, and 8
• Docetaxel — DRUG
  Docetaxel 75mg/m2 on weeks 2, 5, and 8
• Cetuximab — DRUG
  Cetuximab 400mg/m2 on week 1, 250mg/m2 on weeks 2, 3, 4, 5, 6, 7, 8, 9, 10
• Cemiplimab — DRUG
  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
• Surgical Resection of Primary +/- Neck Dissection — PROCEDURE
  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).
• Post-operative radiation therapy — RADIATION
  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.
• Paclitaxel — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jan 20, 2021

Status verified

Mar 2026

Primary completion

Jun 20, 2026

Completion

Jun 20, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Head and Neck Squamous Cell Cancer/HNSCC
  Participants with locally advanced, resectable head and neck squamous cell carcinoma for which standard-of-care management would entail definitive surgery followed by adjuvant radiation +/- concurrent chemotherapy are eligible.
• Experimental: Secondary Cohort
  Participants with locally advanced, resectable head and neck squamous cell carcinoma for which standard-of-care management would entail definitive surgery followed by adjuvant radiation +/- concurrent chemotherapy are eligible.

Primary Outcome Measure

Incidence of toxicities graded according to NCI CTCAE [ Time Frame: 1 year ]

Central Contacts

• Lara Dunn, MD
  646-608-3787
  [email protected]
• David Pfister, MD
  646-888-4237
  [email protected]

Locations (7)

Find similar trials in Basking Ridge, NJ

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