Neoadjuvant Pembrolizumab in Cutaneous Squamous Cell Carcinoma

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.

Timeline

Start

2022-06-28

Primary completion

2025-06-01

Completion

2027-06-01

Publications

• Ladwa R, Lee JH, McGrath M, Cooper C, Liu H, Bowman J, Gupta R, Cuscaden C, Nottage M, Clark JR, Le D, Pauley M, Kulasinghe A, Gonzalez-Cruz J, Porceddu SV, Hughes BGM, Panizza B. Response-Adapted Surgical and Radiotherapy De-Escalation in Resectable Cutaneous Squamous Cell Cancer Using Pembrolizumab: The De-Squamate Study. J Clin Oncol. 2025 Sep 10;43(26):2888-2896. doi: 10.1200/JCO-25-00387. Epub 2025 Jul 21.

Drugs

Indications