Clinical Trial Details

Evaluating the PD-1 checkpoint inhibitor, Cemiplimab, as neoadjuvant therapy in high risk localized, locally recurrent and regionally advanced cutaneous squamous cell carcinoma: a Phase II pilot study (NeoPOWER)

Categories (click each to see list of all clinical trials associated with that category): Dermatology (ONC), Head & Neck (ONC), Melanoma (ONC), Thoracic (ONC)

Current Status: Open

Phase: II (Cancer Control)

Principal Investigator: Marr, Alissa

Contact Information:
Amanda Redmond
aredmond@unmc.edu

Eligibility: https://clinicaltrials.gov/ct2/show/NCT04154943?term=NCT04154943&draw=2&rank=1#eligibility

Summary
STUDY OBJECTIVES This study will enroll patients to a single-arm, open label study that assesses the efficacy of neoadjuvant Cemiplimab in cutaneous squamous cell carcinoma (CSCC). All patients will have CSCC that is deemed potentially resectable, including (1) high-risk localized CSCC, (2) locally recurrent CSCC, and (3) regionally advanced CSCC. Primary Objectives To assess the pathological partial response (PPR) rate in patients with potentially resectable CSCC treated with neoadjuvant Cemiplimab Secondary Objectives To estimate the pathological complete response rate (PCR) To estimate the RECIST (v1.1) 9 week objective response rate (ORR) To estimate the RECIST (v1.1) 12 month progression free (PFS) To assess the toxicity among patients with CSCC treated with neoadjuvant Cemiplimab Exploratory Objectives To evaluate tumor mutational burden (TMB) and correlate with response to PD-1 blockade therapy To evaluate PD-L1 expression on CSCC tumor cells and correlate with response to PD-1 blockade To evaluate CD8+ T cell infiltration into CSCC tumors and correlate with response to PD-1 blockade To assess other adaptive immune resistance mechanisms in CSCC tumors