Actively Recruiting
Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer
Led by Emory University · Updated on 2025-08-14
20
Participants Needed
1
Research Sites
593 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with high risk cutaneous squamous cell carcinoma (cSCC) meeting specific criteria such as nodal disease with extracapsular extension, in-transit metastases, T4 head and neck lesion, perineural invasion, or recurrent cSCC with defined features
- Cancer confirmed to be surgically resectable with planned surgery evaluation prior to resection
- No prior systemic immunotherapy or anti-PD1 therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Hemoglobin level of at least 9.0 g/dl within 28 days before starting treatment
- Absolute neutrophil count of at least 1,500/mcL within 28 days before starting treatment
- Platelet count of at least 100,000/mcL within 28 days before starting treatment
- Total bilirubin less than or equal to 1.5 times institutional upper limit of normal within 28 days before treatment
- AST/ALT less than or equal to 2.5 times institutional upper limit of normal within 28 days before treatment
- Albumin level of at least 3.0 g/dL within 28 days before starting treatment
- Serum creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance of at least 50 mL/min within 28 days before treatment
- International normalized ratio (INR) less than or equal to 1.5 within 28 days before treatment; anticoagulation allowed only with stable low molecular weight heparin
- Prior cancer therapy side effects must be grade 1 or resolved except for alopecia and sensory neuropathy; certain controlled adrenal insufficiency or hypothyroidism allowed
- Prior or concurrent malignancies allowed if they do not interfere with study safety or efficacy
- Female participants of child-bearing potential must have a negative pregnancy test before starting therapy
- Both females of child-bearing potential and males must agree to use effective contraception during and for 6 months after treatment
- Participants must agree not to donate blood or reproductive material during treatment and for 6 months after
- Willingness and ability to comply with study visits, treatments, tests, and restrictions
- Signed informed consent acknowledging understanding of disease, procedures, risks, and study nature
You will not qualify if you...
- Not a surgical candidate due to medical conditions or extent of disease
- Current treatment with chronic immunosuppressants such as cyclosporine
- Prior organ transplant or allogeneic bone marrow transplant
- History or active immune-mediated diseases like pneumonitis, colitis, hepatitis, nephritis, or skin reactions
- Need for systemic corticosteroids over 10 mg prednisone equivalents or other immunosuppressants within 14 days before study drug
- Pregnant or breastfeeding women
- Uncontrolled illnesses including certain infections, heart failure (NYHA class III/IV), unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- Other medical conditions or medications that may increase risk or interfere with study participation or results
- Evidence of bleeding disorders
- History of severe allergic reactions
- Prior malignancies unless disease-free for more than 3 years
- Prior low-risk non-melanoma skin cancers or in situ carcinomas unless completely removed
- Use of other investigational drugs within 28 days or at least 5 half-lives before study drug
- History of severe hypersensitivity to monoclonal antibodies
- Receipt of non-oncology vaccines within 28 days before starting treatment
- Prisoners or compulsory detained individuals
AI-Screening
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Trial Site Locations
Total: 1 location
1
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
M
Michael Lowe, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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