Locally Advanced Basal Cell Carcinoma Clinical Trial
Official title:
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.
PRIMARY OBJECTIVE: I. To assess treatment response of locally advanced basal cell carcinoma (BCC) of the head and neck (BCCHN) in the neoadjuvant, presurgical setting. SECONDARY OBJECTIVES: I. To assess functional organ preservation with neoadjuvant Cemiplimab therapy. II. To assess pathologic response. III. To assess safety of neoadjuvant therapy. IV. To assess changes in quality of life. EXPLORATORY OBJECTIVE: I. To assess treatment-related changes in the immune microenvironment related to functional changes in immune cell composition. OUTLINE: Patients receive cemiplimab intravenously (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 standard of care (SOC) hedgehog inhibitor (HHI) therapy. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) scans and collection of blood samples throughout the trial. Patients also undergo biopsies during screening and on study. Upon completion of study treatment, patients are followed up at 3 months and 6 months. ;
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