Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma (NCT06418724) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma
27 participantsStarted 2026-07-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Adequate hepatic function with total bilirubin levels \<1.5 upper limit normal range and Alanine aminotransferase (ALT) and AST levels \<2.5 level normal range.
✓. Adequate renal function with eGFR estimated with Cockcroft Gault formula \>50mL/min. Serum potassium levels 3.5 - 5.5 mmoL/L, Serum magnesium levels 0.7 - 1.05 mmol/L, Serum corrected calcium levels 2.15 - 2.55 mmol/L
✓. Adequate performance status of Eastern Cooperative Oncology Group (ECOG) 0-1 as assessed by investigator
✓. Life expectancy of \>6 months
Exclusion criteria
✕
What they're measuring
1
Preliminary activity
Timeframe: 3 months
Trial details
NCT IDNCT06418724
SponsorMelanoma and Skin Cancer Trials Limited
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-07-30
Contact for this trial
Melanoma and Skin Cancer Trials Ltd Project Officer
. 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
✕. Corticosteroid use of \>10mg daily of oral prednisone within 2 weeks of Cycle 1 Day 1 (C1D1)
✕. Known history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases.
✕. Uncontrolled infection with human immunodeficiency virus, hepatitis B, or hepatitis C infection; or has a diagnosis of immunodeficiency