About this trial
The NEOPECS trial is a phase II prospective, single-arm, non-randomised interventional trial for patients with borderline resectable locally advanced cutaneous squamous cell carcinoma with a 6-participant safety lead in to ensure safety of the combination in the neoadjuvant setting across 3 sites in Australia.
Eligibility criteria
Qualifiers
Male or female > 18 years of age and able to comply with treatment, assessment and follow up
Documentation of a locally advanced cutaneous squamous cell carcinoma diagnosis as evidenced by histopathology with available archival tissue. Locally Advanced cutaneous Squamous Cell Carcinoma (LASCC) defined as borderline resectable for surgery due to multiple recurrences, prior radiotherapy, large extension, bone erosion and/or deep infiltration beyond the subcutaneous tissue into muscle/nerve or, where curative resection may lead to unacceptable complications, morbidity or deformity, and ineligible for curative radiotherapy
Measurable disease in accordance with iRECIST criteria OR clinically measurable disease >1cm by caliper measurement. Patients with synchronous primary cutaneous squamous cell carcinoma (cSCC) tumours will be eligible.
Adequate bone marrow function with haemoglobin >100g/L, absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L). Blood transfusion is allowable.
Disqualifiers
Distant metastatic disease (M1) including visceral or distant nodal metastases
Prior receipt of checkpoint inhibitor therapy or anti-EGFR therapy for LASCC or any other malignancy
Uncontrolled medical/psychiatric co-morbidity as per investigator that may jeopardize the ability of the patient to undergo trial procedures with reasonable safety
Uncontrolled autoimmune disease requiring active immune-suppression within 1 year of enrolment
Trial design
Treatments tested in this trial
- Cetuximab
- Cemiplimab