NEOPECS

Advancing neoadjuvant therapy in cSCC

Cutaneous squamous cell carcinoma (cSCC) is the second most common cancer worldwide, with Australia reporting some of the highest incidence rates globally. Most cSCCs occur on sun-exposed areas of the head and neck. 

While early-stage disease is often treated successfully with surgery alone, advanced cSCC frequently requires extensive surgery followed by radiation therapy. These treatments can result in significant long-term morbidity, including long-term side effects and permanent disfigurement. Consequently, there is a strong unmet need for strategies that can reduce the extent of surgery required, improve treatment outcomes, and lower the risk of disease recurrence following surgery.

The NEOPECS clinical trial is testing a new treatment combination that aims to determine the safety and efficacy of neoadjuvant cemiplimab and cetuximab in patients with locally advanced cutaneous squamous cell carcinoma (LAcSCC). Three sites across Melbourne, Sydney and Brisbane will aim to recruit 27 participants. 

Eligibility

To participant in the NEOPECS trial, participants must be aged 18 years or older, have been diagnosed with LAcSCC, have a life expectancy of more than six months and are considered not suitable for surgical treatment.

 Additional inclusion and exclusion criteria apply.

What's involved?

Participants will receive up to four cycles of cemiplimab and cetuximab. They will then be reviewed for their eligibility for surgery and followed-up for up to 24 months.

There will be a safety committee review after the treatment of the first six participants. If the evaluation confirms the safety and tolerability of the study treatment, recruitment for the remainder for the participants will continue.  

Why is the NEOPECS trial important?

The NEOPECS trial gives these patients the opportunity to try a new combination treatment that could extend and improve their quality of life.

The results from the NEOPECS trial will inform treatment guidelines for patients with locally advanced cutaneous squamous cell carcinoma and further medical knowledge for this condition.

NEOPECS trial team

  • A/Prof Jia (Jenny Liu) – Study Chair – The Kinghorn Cancer Centre, St Vincent’s Hospital Sydney and University of New South Wales
  • Prof Anthony Joshua, The Kinghorn Cancer Centre, St Vincent’s Hospital Sydney and University of New South Wales
  • Dr Anthony Rodriguez, The Kinghorn Cancer Centre, St Vincent’s Hospital Sydney
  • Dr James Pham, The Kinghorn Cancer Centre, St Vincent’s Hospital Sydney
  • Dr Miles Andrews, Alfred Hospital and Monash University
  • A/Prof Rahul Ladwa, Princess Alexandra Hospital and University of Queensland

Trial sites planned to open for recruitment

St Vincent’s Hospital Sydney, NSW

The Alfred Hospital, Melbourne VIC

Princess Alexandra Hospital, Brisbane QLD

Contact and more information

To contact the NEOPECS clinical trial team email neopecs@masc.org.au

NEOPECS clinical trial provisional Registration ID: NCT06418724

For information on how to participate in a clinical trial, click here.