Study on Cemiplimab Injections for Early Stage Skin Cancer (Cutaneous Squamous Cell Carcinoma)
Sponsor: Regeneron Pharmaceuticals
ClinicalTrials ID:NCT06585410
This clinical trial is testing a drug called cemiplimab to see if it can help treat early-stage skin cancer known as cutaneous squamous cell carcinoma (CSCC). The study aims to find out if cemiplimab, when injected directly into the cancer, works as well as surgery.
Patient Parameters
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Program Overview
The purpose of this study is to test a drug called cemiplimab for treating early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab helps the immune system fight cancer by targeting a protein called PD-1 on immune cells. The study will compare the effectiveness of cemiplimab injections directly into the cancer against traditional surgery. Researchers will also monitor any side effects caused by cemiplimab and how well it works in shrinking the cancer.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of invasive cutaneous squamous cell carcinoma (CSCC) that is between 1 cm and 2 cm in size, located on the head, neck, hand, or lower leg.
- Be eligible for surgery to remove the cancer, with plans for a specific type of surgery that checks the edges of the removed tissue (like Mohs surgery).
- Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have good liver, kidney, and bone marrow function as determined by specific medical tests.
Exclusion Criteria
- Have a type of skin lesion that is not suitable for this study, such as keratoacanthoma, adenosquamous carcinoma, or basal cell carcinoma.
- Have a history of significant autoimmune disease that required treatment with medications that suppress the immune system in the past 5 years.
- Have had non-infectious lung inflammation (pneumonitis) in the last 5 years.
- Have a cancer lesion planned for treatment that is located on the lip, inside the mouth, or in the nose.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Medical Dermatology Specialists | 85006 | Phoenix | Arizona |
| Dermatology Associates of the Palm Beaches | 33445 | Delray Beach | Florida |
| University Skin Oncologists Inc | 01915 | Beverly | Massachusetts |
| Rochester Dermatologic Surgery, P.C. | 14564 | Victor | New York |
| Reveal Research Institute | 75235 | Dallas | Texas |
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