Clinical Trials Search
Clinical Trial 18587
Study Type: Treatment
Phase of Study: Phase II
- Nikhil Khushalani
A Phase 2 Study of REGN2810, A Fully Human Monoclonal Antibody to Programmed Death 1(PD-1), in Patients with Advanced Cutaneous Squamous Cell Carcinoma
The purpose of this study is to test the effects of REGN2810 (''study drug") in participants with advanced cutaneous squamous cell carcinoma (CSCC).
The primary objective of this study is to estimate the clinical benefit of REGN2810 monotherapy for patients with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC) (Group 1) or with unresectable locally advanced CSCC (Group 2), as measured by overall response rate (ORR), according to central review. The secondary objectives of the study are: To estimate ORR according to investigator review. To estimate the duration of response, progression-free survival (PFS), and overall survival (OS) by central and investigator review. To estimate the complete response (CR) rate by central review. To assess the safety and tolerability of REGN2810. To assess the pharmacokinetics (PK) of REGN2810 (at select sites only). To assess the immunogenicity of REGN2810. To assess the impact of REGN2810 on quality of life using EORTC QLQ-C30.