NCT03565783

Cemiplimab in Treating Patients With Recurrent and Resectable Stage II-IV Head and Neck Cutaneous Squamous Cell Cancer Before Surgery

Phase II Study of REGN2810 Prior to Surgery in Patients With Stage II-IV Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well cemiplimab works before surgery in treating patients with stage II-IV head and neck cutaneous squamous cell cancer that has come back (recurrent) and can be removed by surgery (resectable). 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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the overall response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria to neoadjuvant cemiplimab (REGN2810) in patients with stage II-IV cutaneous squamous cell carcinoma (cSCC) of the head and neck who are planned for definitive local surgery with or without radiation. SECONDARY OBJECTIVES: I. To determine the pathologic response rate to neoadjuvant REGN2810 in patients with stage II-IV cSCC of the head and neck. II. To determine the safety and tolerability of neoadjuvant REGN2810 in patients with stage II-IV cSCC of the head and neck who are planned for definitive local surgery and radiation. III. To estimate the 2-year disease-specific (DSS), disease-free (DFS) and overall survival (OS) compared to historical controls. IV. To determine the time to recurrence and patterns of failure. V. To evaluate the effects of neoadjuvant REGN2810 on the expression of PD-1 and potential related immune regulating targets in cSCC of the head and neck. OUTLINE: Patients receive cemiplimab intravenously (IV) over 30 minutes every 3 weeks. Cycles repeat every 3 weeks for up to 6 weeks with or without radiation therapy at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then periodically for up to 5 years.

Conditions

• Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck
• Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck
• Stage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
• Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
• Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	Cemiplimab	Given IV

Timeline

• Start date: 2018-07-03
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2018-06-21
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study