Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
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 criteria
Qualifiers
Nodal disease with extracapsular extension (ECE) and at least one node >= 20 mm on the surgical pathology report
In-transit metastases (ITM) defined as skin or subcutaneous metastases that are > 2 cm from the primary lesion but are not beyond the regional nodal basin
T4 lesion for head and neck CSCC
Perineural invasion (PNI), defined as clinical and/or radiologic involvement of named nerves
Disqualifiers
Determined not to be a surgical candidate due to medical co-morbidities or extent of disease
Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)
Prior organ allograft or allogeneic bone marrow transplantation
Subjects with active or history of immune mediated pneumonitis, colitis, hepatitis, nephritis, or skin reactions as these patients may be at increased risk for developing immune therapy-induced exacerbation or recurrence of their immune mediated disease, potentially delaying surgery
Trial design
Treatments tested in this trial
- Cemiplimab
- Radiation Therapy
- Therapeutic Conventional Surgery
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov