Neoadjuvant Pembrolizumab in Cutaneous Squamous Cell Carcinoma

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 r

Trial Details

NCT ID
NCT05025813
Phase
PHASE2
Sponsor
Queensland Health
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Pembrolizumab
Locations (sample)
  • Camperdown, New South Wales, Australia|-33.88965,151.17642
  • Herston, Queensland, Australia|-27.44453,153.01852
  • Woolloongabba, Queensland, Australia|-27.48855,153.03655

Key Eligibility Criteria

  • Histologically confirmed diagnosis of invasive cSCC that is locally advanced (Stage II-IV on AJCC 8th edition) assessed preoperatively as sufficien…
  • Note: Participants with tumors arising on cutaneous non-glabrous (hair-bearing) lip with extension onto vermillion (dry red lip) may be eligible af…
  • Participants must have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progre…
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days prior to the start of treatment.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Head and Neck Cancer Trials on Trialify →