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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood and/or plasma
• Cemiplimab — BIOLOGICAL
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT and/or PET/CT
• Image Guided Radiation Therapy — RADIATION
  Undergo IGRT
• Intensity-Modulated Radiation Therapy — RADIATION
  Undergo IMRT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT
• Questionnaire Administration — OTHER
  Ancillary studies
• Surgical Procedure — PROCEDURE
  Undergo surgery per SOC
• Surgical Procedure — PROCEDURE
  Undergo response-adaptive surgery

Study Details

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.

Key Dates

Start date

Feb 18, 2025

Status verified

May 2026

Primary completion

Aug 14, 2031

Completion

Aug 14, 2031

Study Design

Enrollment

420 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm 1 (surgery, radiation)
  Patients undergo surgery per standard of care within 6 weeks of randomization. Starting within 6-12 weeks of surgery, patients may undergo IGRT with IMRT for 5 fractions per week for 6 weeks as clinically indicated. Patients also undergo CT, MRI, and/or PET/CT prior to treatment, and CT and/or MRI during follow up. Patients may also undergo optional collection of tissue, whole blood, and plasma on study.
• Experimental: Arm 2 (cemiplimab, surgery, radiation)
  Patients receive cemiplimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo response-adaptive surgery 21 days after last dose of cemiplimab. Starting within 12 weeks of surgery, patients may undergo IGRT with IMRT for 5 fractions per week for 6 weeks as clinically indicated. Starting within 6 weeks of completion of surgery or radiation therapy (if indicated), patients without pCR receive cemiplimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or PET/CT prior to treatment, and CT and/or MRI on study and during follow up. Patients may also undergo optional collection of tissue, whole blood, and plasma on study.

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: Up to 6 years ]

Locations (196)

Find similar trials in Birmingham, AL

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