Study Details
The Benefits and Side Effects of Injected Cemiplimab into Tumors Compared to Removing Tumors Surgically for People with Early-Stage Cutaneous Squamous Cell Cancer
(IRB#: IRB_00191239)
This study will test a drug called cemiplimab (se-mip-li-mab) to see if it can help treat early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. Cemiplimab is used to treat locally advanced (cancer that has grown but has not spread to other parts of the body) or metastatic (cancer that has spread) CSCC. Cemiplimab is also used to treat other types of cancer (such as basal cell carcinoma and cervical cancer). Cemiplimab is usually given as an injection into the vein. In this study, cemiplimab will be given by an injection into the tumor (intralesional cemiplimab). Some people will be given cemiplimab injections for 6 weeks, and some people will have their tumor removed by surgery, which is the usual treatment that people have for early-stage CSCC. This will help researchers compare how well cemiplimab works compared to surgery. Being in the study lasts up to 3 years.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 18 years and older
- Have a biopsy-proven diagnosis of invasive Cutaneous squamous cell carcinoma (CSCC)
- Have a lesion of CSCC that is between 1 to 2 cm (longest diameter) located on the head, neck, hand, or lower leg
- Willing to comply with clinic visits and study-related procedures including surgical resection of the lesion, medical photography of the lesion, and long-term post treatment follow-up care
- Must use specific birth control during study participation
Exclusion Criteria
- Ongoing or recent evidence of significant autoimmune disease
- Currently taking certain medicines, such as anti-cancer treatment
- History of solid organ transplant
- Participation in another study
- Pregnant or breastfeeding
Will I be paid for my time?
Yes
IRB#: IRB_00191239
PI: Keith Duffy
Department: DERMATOLOGY
Approval Date: 2025-10-08 06:00:00
Study Categories: Cancer Studies
Specialties: Dermatology
I am Interested