Randomized Phase III Trial of Neoadjuvant Immunotherapy With Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma (C-PRE)

Official Summary

This phase III trial compares the effect of adding cemiplimab to standard therapy (surgery with or without radiation) versus standard therapy alone in treating patients with stage III/IV squamous cell skin cancer that is able to be removed by surgery (resectable) and that may have come back after a period of improvement (recurrent). The usual treatment for patients with resectable squamous cell skin cancer is the removal of the cancerous tissue (surgery) with or without radiation, which uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cemiplimab has been approved for the treatment of skin cancer that has spread or that cannot be removed by surgery, but it has not been approved for the treatment of skin cancer than can be removed by surgery. Adding cemiplimab to the usual treatment of surgery with or without radiation may be more effective in treating patients with stage III/IV resectable squamous cell skin cancer than the usual treatment alone.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 420 participants

Interventions

• PROCEDURE: Biospecimen Collection — Undergo collection of blood and/or plasma
• BIOLOGICAL: Cemiplimab — Given IV
• PROCEDURE: Computed Tomography — Undergo CT and/or PET/CT
• RADIATION: Image Guided Radiation Therapy — Undergo IGRT
• RADIATION: Intensity-Modulated Radiation Therapy — Undergo IMRT

Primary Outcomes

• Event-free survival (EFS) (Up to 6 years)

Secondary Outcomes

• Utilization of adjuvant radiation (Up to 6 years)
• Disease-free survival (DFS) (From randomization to recurrent or death, assessed up to 6 years)
• Overall survival (OS) (From randomization to death, assessed up to 6 years)
• Incidence of adverse events (At 30 days and then up to 6 years)
• Pathologic complete response (At 1 and 2 years)

Trial Locations

• University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
• Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
• Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
• Tower Cancer Research Foundation, Beverly Hills, California, United States
• City of Hope Comprehensive Cancer Center, Duarte, California, United States
• UC San Diego Health System - Encinitas, Encinitas, California, United States
• City of Hope at Irvine Lennar, Irvine, California, United States
• UC San Diego Moores Cancer Center, La Jolla, California, United States
• City of Hope Antelope Valley, Lancaster, California, United States
• The Angeles Clinic and Research Institute - West Los Angeles Office, Los Angeles, California, United States
• ...and 10 more locations

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