Overview

Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC

Status:
Recruiting
Trial end date:
2027-08-07
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to evaluate the clinical activity of neoadjuvant cemiplimab therapy in patients with resectable Non-small cell lung cancer (NSCLC), Hepatocellular carcinoma (HCC), and Head and neck squamous cell carcinoma (HNSCC) lesions, as measured by pathological evaluations of resected tumors. The secondary objectives of the study are: - To assess the anti-tumor activity of neoadjuvant and adjuvant cemiplimab therapy as defined by multiple criteria - To determine the safety and tolerability of neoadjuvant and adjuvant cemiplimab therapy including delay to surgery - To assess the change in tumor-infiltrating CD8 T-cell density and to explore the correlation to the pathological response to therapy
Phase:
Phase 2
Details
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborator:
Sanofi
Treatments:
Cemiplimab