OncoMatch/Clinical Trials/NCT05025813
Neoadjuvant Pembrolizumab in Cutaneous Squamous Cell Carcinoma
Is NCT05025813 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab for cutaneous squamous cell carcinoma of the head and neck.
Treatment: Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage II, III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Participant has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
Cannot have received: systemic anti-cancer therapy
Exception: for cSCC
Participant has received prior systemic anti-cancer therapy including investigational agents for cSCC.
Cannot have received: radiation therapy
Exception: to the target lesion
Participant has received prior radiotherapy to the target lesion.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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