Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery
Neoadjuvant REGN2810 (Cemiplimab) or REGN2810 (Cemiplimab) Plus REGN3767 (Fianlimab) in Cutaneous Basal Cell Carcinoma of the Head and Neck
Thomas Jefferson University
70 participants
Jul 5, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
Given IV
Undergo CT scan
Undergo collection of blood samples
Ancillary studies
Undergo MRI
Undergo biopsy
Fianlimab (REGN3767) administered intravenously in combination with Cemiplimab.
Locations(3)
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NCT05929664