NCT05025813

Neoadjuvant Pembrolizumab in Cutaneous Squamous Cell Carcinoma

A Phase 2 Study of De-escalation in Resectable, Locally Advanced Cutaneous Squamous Cell Carcinoma With the Use of Neoadjuvant Pembrolizumab - DESQUAMATE

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Queensland Health · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cutaneous Squamous Cell Carcinoma (cSCC) is typically associated with a high tumour mutation burden, with the majority caused by Ultraviolet (UV) exposure (Pickering et al., 2014). The use of this trial using neoadjuvant Pembrolizumab in patients with cSCC who will otherwise undergo highly morbid radical surgical resection has multiple potential advantages, including: 1. Reduction in surgical and radiotherapy morbidity by reducing tumour burden and allowing the appropriate selection of patients to undergo post-operative radiotherapy; 2. Provision of immediate information about pathological response and 3. Access to tissue to provide insight into resistance mechanisms and identification of biomarkers of response. The Investigators hypothesized that the use of neoadjuvant Pembrolizumab could reduce tumour burden allowing appropriate selection of patients undergoing radical surgical resection and adjuvant radiotherapy.

Conditions

• Cutaneous Squamous Cell Carcinoma of the Head and Neck
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Delivery of neo-adjuvant Pembrolizumab

Timeline

• Start date: 2022-06-28
• Primary completion: 2025-06-01
• Completion: 2027-06-01
• First posted: 2021-08-27
• Last updated: 2022-08-01

Locations

3 sites across 1 country: Australia