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:
Lucinda Kustka
lucinda.kustka@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