Actively Recruiting
Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery
Led by Thomas Jefferson University · Updated on 2026-03-24
70
Participants Needed
3
Research Sites
417 weeks
Total Duration
On this page
Sponsors
T
Thomas Jefferson University
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
A non-randomized two-cohort study of neoadjuvant Cemiplimab or neoadjuvant Cemiplimab plus Fianlimab (CF) in patients with basal cell carcinoma of the head and neck. Enrollment in the dual-therapy cohort will begin after completion of enrollment in the monotherapy cohort. Patients will undergo at least 2 and up to 6 infusions of immunotherapy prior to surgical resection. If patients have progression on neoadjuvant treatment, they may switch to standard of care surgical resection or hedgehog inhibitors prior to surgery. The primary endpoints are objective response rate and disease control rate. Safety and surgical benefit rate (de-escalation of surgery) with preservation of key anatomic structures are secondary endpoints. Correlative endpoints include analysis of pre and post treatment primary tumor and blood samples compared for histology, tumor genetics and immune cell composition.
CONDITIONS
Official Title
Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed locally advanced basal cell carcinoma of the head and neck not resectable without major morbidity or unresectable as defined by specified surgical criteria
- Male or female aged 18 years or older
- Performance status of 0-1
- Life expectancy of at least 6 months as judged by treating physician
- Adequate organ function including neutrophil count ≥1500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL, bilirubin ≤1.5 times upper limit of normal (≤3 mg/dL if Gilbert syndrome), AST and ALT ≤2.5 times upper limit of normal, and glomerular filtration rate ≥40 mL/min
- Women of reproductive potential must have a negative pregnancy test within 28 days before starting study drugs
- Women of reproductive potential must use effective contraception for 120 days after last dose; defined by menarche, surgical sterilization status, menopause criteria, and hormone levels
- Men who are sexually active with women of reproductive potential must use effective contraception for 120 days after last dose unless azoospermic
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior radiation therapy within 6 months for the target cancer
- Allergy to any study drug components
- Concurrent malignancies except certain skin cancers and cancers treated curatively with no recurrence for 2 years
- Unresolved Grade 2 or higher toxicity from previous cancer therapy except alopecia and vitiligo; Grade 2 neuropathy evaluated case-by-case
- Need for systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive drugs within 28 days before study drug or history of organ transplantation
- Significant connective tissue disorders
- Participation in other investigational drug studies
- Receipt of live attenuated vaccine within 30 days before first study dose
- Uncontrolled illnesses including infections, heart failure, hypertension, unstable angina, arrhythmia, lung disease, serious gastrointestinal conditions, or psychiatric/social issues compromising compliance
- Pregnancy or breastfeeding
- Active infections including tuberculosis, hepatitis B or C, or HIV
- Prior immunotherapy or hedgehog inhibitor treatment for malignancy
- Untreated active brain metastases
- History of pneumonitis within past 5 years
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of Miami Health System
Miami, Florida, United States, 33136
Actively Recruiting
2
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
3
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
J
Joseph Curry, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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