NCT06418724

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Melanoma and Skin Cancer Trials Limited · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Locally Advanced Cutaneous Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cetuximab	Cetuximab is a monoclonal antibody against epidermal growth factor receptor (EGFR). EGFR is over-expressed in many human cancers, including colorectal cancers.
DRUG	Cemiplimab	Cemiplimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with its ligands programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2). Engagement of PD-1 with its ligands PD-L1 and PD-L2, which are expressed by antigen presenting cells and may be expressed by tumour cells and/or other cells in the tumour microenvironment, results in inhibition of T cell function such as proliferation, cytokine secretion, and cytotoxic activity. Cemiplimab potentiates T cell responses, including antitumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.

Timeline

• Start date: 2026-07-30
• Primary completion: 2026-07-30
• Completion: 2030-12-01
• First posted: 2024-05-17
• Last updated: 2026-03-27