Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma

Sponsor
Melanoma and Skin Cancer Trials Limited
Study ID
NCT06418724
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Locally Advanced Cutaneous Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cetuximab — DRUG
    Cetuximab is a monoclonal antibody against epidermal growth factor receptor (EGFR). EGFR is over-expressed in many human cancers, including colorectal cancers.
  • Cemiplimab — DRUG
    Cemiplimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with its ligands programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2). Engagement of PD-1 with its ligands PD-L1 and PD-L2, which are expressed by antigen presenting cells and may be expressed by tumour cells and/or other cells in the tumour microenvironment, results in inhibition of T cell function such as proliferation, cytokine secretion, and cytotoxic activity. Cemiplimab potentiates T cell responses, including antitumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.

Study Details

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.

Key Dates

Start date
Jul 30, 2026
Status verified
Mar 2026
Primary completion
Jul 30, 2026
Completion
Dec 1, 2030

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cetuximab and Cemiplimab
    All patients will be administered the same treatment combination. Cemiplimab will be administered 350mg intravenously every 21 days. A maximum of 4 cycles will be given. Cetuximab will be administered 400mg/m2 loading dose on day 1 and 250mg/m2 on day 8 and day 15 for a 21 day cycle for first cycle. Cetuximab will be administered 250mg/m2 on day 1, 8 and 15 for a 21 day cycle for subsequent cycles for 4 cycles.

Primary Outcome Measure

Preliminary activity [ Time Frame: 3 months ]

Central Contacts

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