Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer

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.

Conditions

• Eyelid Squamous Cell Carcinoma
• Recurrent Eyelid Squamous Cell Carcinoma
• Recurrent Skin Acantholytic Squamous Cell Carcinoma
• Recurrent Skin Clear Cell Squamous Cell Carcinoma
• Recurrent Skin Lymphoepithelial Carcinoma
• Recurrent Skin Spindle Cell Squamous Cell Carcinoma
• Recurrent Skin Squamous Cell Carcinoma With Sarcomatoid Differentiation
• Resectable Eyelid Squamous Cell Carcinoma
• Resectable Skin Acantholytic Squamous Cell Carcinoma
• Resectable Skin Clear Cell Squamous Cell Carcinoma
• Resectable Skin Lymphoepithelial Carcinoma
• Resectable Skin Spindle Cell Squamous Cell Carcinoma
• Resectable Skin Squamous Cell Carcinoma With Sarcomatoid Differentiation
• Skin Acantholytic Squamous Cell Carcinoma
• Skin Clear Cell Squamous Cell Carcinoma
• Skin Lymphoepithelial Carcinoma
• Skin Spindle Cell Squamous Cell Carcinoma
• Skin Squamous Cell Carcinoma With Sarcomatoid Differentiation
• Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
• Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8

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

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Surgical Procedure

Undergo surgery per SOC

PROCEDURE

Surgical Procedure

Undergo response-adaptive surgery

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Neil D Gross · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-18

Primary Completion

2031-08-14

Completion

2031-08-14

FDA Drug

Yes

Countries

• United States
• Australia
• Canada

Study Locations