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Brief Title: Neoadjuvant Pembrolizumab in Cutaneous Squamous Cell Carcinoma
Official Title: A Phase 2 Study of De-escalation in Resectable, Locally Advanced Cutaneous Squamous Cell Carcinoma With the Use of Neoadjuvant Pembrolizumab - DESQUAMATE
Study ID: NCT05025813
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Name: Rahul Ladwa, MD
Affiliation: Queensland Health
Role: PRINCIPAL_INVESTIGATOR