Neoadjuvant REGN2810 (Cemiplimab) in Cutaneous Basal Cell Carcinoma of the Head and Neck

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Procedure, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
University of Miami Health System
RECRUITING
Miami
Pennsylvania
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
Tennessee
Vanderbilt University
RECRUITING
Nashville
Contact Information
Primary
Joseph Curry, MD
Joseph.Curry@Jefferson.edu
215-955-6760
Time Frame
Start Date: 2023-07-05
Estimated Completion Date: 2027-07-05
Participants
Target number of participants: 35
Treatments
Experimental: Treatment (cemiplimab)
Patients receive cemiplimab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may transition to SOC HHI therapy. Patients undergo CT or MRI scans and collection of blood samples throughout the trial. Patients also undergo biopsies during screening and on study.
Related Therapeutic Areas
Sponsors
Leads: Thomas Jefferson University

This content was sourced from clinicaltrials.gov

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