RecruitingPhase 1NCT04428671

Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer

Pilot Study of Neoadjuvant/Adjuvant Cemiplimab for High Risk Cutaneous Squamous Cell Carcinoma


Sponsor

Emory University

Enrollment

20 participants

Start Date

May 15, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies how well cemiplimab before and after surgery works in treating patients with high risk cutaneous squamous cell cancer. 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. Giving cemiplimab before surgery may improve risk of the cancer returning in patients with high risk cutaneous squamous cell cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an immunotherapy drug called cemiplimab given before and after surgery for people with high-risk skin cancer (cutaneous squamous cell carcinoma, or cSCC) that has spread to nearby lymph nodes. **You may be eligible if...** - You have been diagnosed with high-risk cutaneous squamous cell carcinoma - Your cancer has spread to lymph nodes with involvement outside the lymph node capsule, or you have multiple large affected lymph nodes - You are able to have surgery - You are 18 or older **You may NOT be eligible if...** - Surgery is not an option for you due to other health problems - You are currently taking long-term immunosuppressant drugs (e.g., anti-rejection medication after an organ transplant) - You have had a prior organ transplant - You have had severe immune-related side effects from similar drugs in the past Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCemiplimab

Given IV

RADIATIONRadiation Therapy

Undergo standard of care radiation therapy

PROCEDURETherapeutic Conventional Surgery

Undergo standard of care surgery


Locations(1)

Emory University/Winship Cancer Institute

Atlanta, Georgia, United States

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NCT04428671


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