RecruitingPhase 2NCT05025813

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


Sponsor

Queensland Health

Enrollment

27 participants

Start Date

Jun 28, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial studies whether giving the immunotherapy drug pembrolizumab (Keytruda) before surgery can shrink locally advanced skin squamous cell carcinoma tumors and improve outcomes. Patients receive a few doses before their surgery, and researchers look at how the tumor responds. **You may be eligible if...** - You have been diagnosed with invasive, locally advanced skin squamous cell carcinoma (Stage II–IV) - Your medical team has already determined surgery and post-surgery radiation are needed - You have measurable disease and are in good general health (ECOG 0–1) - You have adequate organ function and a tumor tissue sample available **You may NOT be eligible if...** - Your cancer has recurred in the same spot after 2 or more surgeries - Your tumor originates from nasal mucosa or glabrous (non-hair-bearing) skin without specialist approval - You have had prior immunotherapy that caused severe side effects - Your organ function does not meet study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Delivery of neo-adjuvant Pembrolizumab


Locations(3)

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

View Full Details on ClinicalTrials.gov

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NCT05025813


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