Neoadjuvant REGN2810 (Cemiplimab) in Cutaneous Basal Cell Carcinoma of the Head and Neck
This phase II trial tests how well cemiplimab works in treating basal cell carcinoma of the head and neck that has spread to nearby tissue or lymph nodes (locally advanced) before surgery (neoadjuvant). Cemiplimab is a human recombinant monoclonal IgG4 antibody that may allow the body's immune system to work against tumor cells. Giving cemiplimab before surgery may make the tumor smaller and make it easier to remove.
• Pathologically confirmed, locally-advanced BCC of the head and neck requiring greater than 30% auriculectomy, rhinectomy, upper or lower lip resection, orbital exenteration (due to lid or orbital involvement), facial nerve sacrifice or Brigham and Women's stage 2b or 3 disease of head and neck
• \* Tumor Specific Inclusion Criteria
⁃ Tumor Site: Nose; Inclusion criteria: \>= 30% involvement
⁃ Tumor Site: Lips; Inclusion criteria: \>= 30% involvement
⁃ Tumor Site: Ear; Inclusion criteria: \>= 30% involvement
⁃ Tumor Site: Eyelid; Inclusion criteria: \>= 50% involvement, American Joint Committee on Cancer (AJCC) stage 3
⁃ Tumor Site: Facial Nerve; Inclusion criteria: Clinical determination of need for sacrifice by treating surgeon
⁃ Tumor Site: Orbit; Inclusion criteria: Need for exenteration based on orbital or lid involvement determined by the treating surgeon
⁃ Tumor Site: BCC of the HN, not otherwise included in the above; Inclusion criteria: BWH T2b: 2-3 high risk factors. T3: \>= 4 high risk features or bone invasion. High risk features include: \>= 2 cm, poorly differentiated histology, peak nasal inspiratory (PNI) \>= 0.1 mm on biopsy or gross or radiographic perineural invasion, invasion beyond subcutaneous fat
• Male or female, aged \>= 18 years of age
• Performance status 0-1
• Must have a life expectancy of at least 6 months as judged by the treating physician
• Absolute neutrophil count 1500/ul or more
• Platelets 100,000/ul or more
• Hemoglobin 9 g/dl or more
• Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin \< 3 mg/dl)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x the upper limit of normal
• Glomerular filtration rate (GFR) greater than or equal to 40 ml/min using the Cockcroft-Gault formula or measured creatinine clearance using 24 hours urine collection
• Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]), which must also be confirmed as negative within 28 days of the start of study drugs
• Women of reproductive potential must use highly effective contraception methods to avoid pregnancy for 90 days after the last dose of study drugs. Women of reproductive potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL
• Men of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than 1% per year. Men who are receiving the study medications will be instructed to adhere to contraception for 90 days after the last dose of study drugs. Men who are azoospermic do not require contraception
• Informed Consent: All subjects must be able to comprehend and sign a written informed consent document