Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma — NEOPECS  

Locally Advanced Cutaneous Squamous Cell Carcinoma Clinical Trial

Official title: Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma

Status Not yet recruiting

Clinical Trial Summary

The NEOPECS trial is a phase II prospective, single-arm, non-randomised interventional trial for patients with borderline resectable locally advanced cutaneous squamous cell carcinoma with a 6-participant safety lead in to ensure safety of the combination in the neoadjuvant setting across 3 sites in Australia.

Clinical Trial Description

As cutaneous squamous cell carcinoma typically occurs on sun-exposed areas of the head and neck, surgical resection of advanced disease can have significant morbidity and disfigurement and strategies to downstage disease prior to surgery, improve chance of R0 resection and reduce the risk of post-surgical relapse remain an area of need.

This study aims to determine the preliminary activity and tolerability of neo-adjuvant combination cemiplimab and cetuximab in unresectable locally advanced cutaneous squamous cell carcinoma by clinical downstaging rate to resectable status. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Locally Advanced Cutaneous Squamous Cell Carcinoma

• NCT number: NCT06418724
• Study type: Interventional
• Source: Melanoma and Skin Cancer Trials Limited
• Contact: Melanoma and Skin Cancer Trials Ltd Project Officer
• Phone: +61 3 9903 9022
• Email: neopecs@masc.org.au
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2024
• Completion date: November 1, 2027