Clinical Trial 23204

• Overview

  Study Title:

  A Phase II Study of Neoadjuvant Cetuximab and Cemiplimab in Patients Undergoing Surgery for Head and Neck Squamous Cell Carcinoma

  Objective:

  Primary Objective: - To evaluate the major and complete pathologic response rate of neoadjuvant cetuximab and cemiplimab combination in patients undergoing surgery for HNSCC Secondary Objectives: - To evaluate the EFS in patients treated with the neoadjuvant cetuximab and cemiplimab combination before the surgery for HNSCC - To evaluate the tolerability of the neoadjuvant cetuximab and cemiplimab combination before the surgery for HNSCC

• Treatments

  Therapies:

  Immunotherapy

  Medications:

  Cemiplimab (); Cetuximab (); Erbitux (Cetuximab); REGN2810 (Cemiplimab)

• Inclusion Criteria

  Key Inclusion Criteria:
  • Must be ≥ 18 years of age at the time of consent.
  • Patient (or a legally authorized representative) must understand and voluntarily sign informed consent prior to any study-related assessments/procedures being conducted.
  • Must be able and willing to comply to the study visit schedule and protocol requirements.
  • Must have sufficient archived tumor tissue available for PD-L1 CPS determination. If not, patient must agree to a fresh tumor biopsy before starting the treatments. If patient only had a fine needle aspiration, a fresh biopsy with a core needle or punch biopsy is required.
  • If the primary site is oropharynx, p16/HPV status must be determined. HPV status determined by cell free HPV DNA testing is also acceptable.
  • Must have surgically resectable HNSCC including oral cavity, oropharynx, larynx, and hypopharynx. Patients with p16-positive or HPV-positive unknown primary of head and neck are eligible. Must be newly diagnosed HNSCC with T1-2 N1-3 or T3-4 N0-3 undergoing surgery as a standard of care. If the tumor invades lateral pterygoid muscle, pterygoid plates, lateral nasopharynx, skull base or encases carotid artery, and/or prevertebral fascia involvement, it will be considered as unresectable and excluded.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Must meet the following laboratory criteria. Blood transfusion and/or blood product support are allowed: Absolute neutrophil count (ANC) > 1500/mm3, Hemoglobin > 9.0 g/dL, Platelet count > 100,000/mm3, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > Patients of childbearing potential and patients whose sexual partners are of childbearing potential must be willing to practice an approved method of highly effective birth control with their partners starting at the time of informed consent and for 1 year after the completion of the study treatment regimen. Women of childbearing potential must have a negative pregnancy test within the 7 days prior to enrollment.
  • Other inclusion criteria may apply.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Patients with an active autoimmune disease that has required systemic treatment in past 2 years.
  • Patients with a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Patient with a history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab or if the patient had red meat allergy/tick bite history.
  • Patients with an active infection requiring systemic therapy.
  • Patients with a known history of human immunodeficiency virus (HIV) infection.
  • Patients with a known history of or is positive for Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C (defined as Hepatitis C virus [HCV] ribonucleic acid is detected).
  • Patients who have a history of a left ventricular ejection fraction (LVEF) of > Patients with cardiovascular disease.
  • Other exclusion criteria may apply.

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