NCT04154943

Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma

A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the efficacy of neoadjuvant cemiplimab as measured by Pathologic complete response (pCR) rate per independent central pathology review. The secondary objectives of the study are: * To evaluate the efficacy of neoadjuvant cemiplimab on measures of disease response, including: * Major pathologic response (mPR) rate per independent central pathology review * pCR rate and mPR rate per local pathology review * ORR prior to surgery, according to local assessment using RECIST 1.1 * To evaluate the efficacy of neoadjuvant cemiplimab on event free survival (EFS), disease free survival (DFS), and overall survival (OS) * To evaluate the safety profile of neoadjuvant cemiplimab * To assess change in surgical plan (ablative and reconstructive procedures) from the screening period to definitive surgery, both according to investigator review and independent surgical expert review * To assess change in post-surgical management plan (radiation, chemoradiation, or observation) from the screening period to post-surgery pathology review, both according to investigator review and independent surgical expert review

Conditions

• Cutaneous Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cemiplimab	Intravenous (IV) infusion every 3 weeks (Q3W)

Timeline

• Start date: 2020-03-10
• Primary completion: 2021-12-01
• Completion: 2025-11-19
• First posted: 2019-11-07
• Last updated: 2025-12-23
• Results posted: 2023-02-08

Locations

22 sites across 3 countries: United States, Australia, Germany

Regulatory

• FDA-regulated drug study