Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

To estimate the clinical benefit of cemiplimab monotherapy for patients with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC) (Groups 1 and 3) or with unresectable locally advanced CSCC (Group 2), or with advanced CSCC [metastatic (nodal or distal) or unresectable locally advanced] treated (Group 4) as measured by overall response rate (ORR), according to central review.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 266 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: April 7, 2016
Estimated Primary Completion Date: February 26, 2020
Estimated Study Completion Date: August 11, 2021

Arms:
- Experimental: Group 1
- Experimental: Group 2
- Experimental: Group 3
- Experimental: Group 4