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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Cemiplimab
Biological/VaccineGiven IV
Radiation Therapy
RadiationUndergo standard of care radiation therapy
Therapeutic Conventional Surgery
Procedure/SurgeryUndergo standard of care surgery
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Treatment (cemiplimab)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Pathologic response rate
Defined as the number of complete and partial responses divided by the total number of patients, as assessed by pathology. Pathological complete response (pCR) (no viable tumor) or pathological partial response (pPR) (less than 50% viable tumor) as well as near pCR (less than 10% viable tumor) in the tumor bed will be documented by pathology from the resection specimen. Pathologic response rate will be summarized using frequency and percentage, and a 95% exact confidence interval will be reported using the Clopper-Pearson method.
Time frame
From screening up to 10 years post-treatmentSecondary outcomes
1
Time to local recurrence
Local recurrence-free survival will be estimated using the Kaplan-Meier method.
Time frame
From screening to local recurrence, death, or last known follow-up, assessed up to 10 years post-treatment2
Time to systemic recurrence
Systemic recurrence-free survival will be estimated using the Kaplan-Meier method.
Time frame
From screening to systemic recurrence, death, or last known follow-up, assessed up to 10 years post-treatment3
Overall survival (OS)
OS will be estimated using the Kaplan-Meier method. 6-month, 12-month, and 24-month OS estimates will be reported along with 95% confidence intervals.
Time frame
From screening to death from any cause or last known follow-up, assessed up to 2 years post-treatment4
Recurrence-free survival (RFS)
RFS will be estimated using the Kaplan-Meier method. 6-month, 12-month, and 24-month RFS estimates will be reported along with 95% confidence intervals.
Time frame
From screening to recurrence, death, or last known follow-up, assessed up to 2 years post-treatmentOther outcomes
1
Change in immune system biomarkers
Pre- and post-surgery assessments of biomarkers extracted from tissue and blood samples will be summarized using frequencies and percentages for categorical variables, and mean, median, standard deviation, and range for numeric variables. Pre- versus (vs.) post-surgery values will be compared using paired t-tests or McNemar's tests, where appropriate. Biomarkers extracted from blood samples will also be collected at progression or completion of adjuvant therapy. In those cases, mixed models with a random intercept will be explored to assess the impact of time on change in biomarker status. Change in biomarker will be compared across response (yes/no) using two-sample t-tests or Mann Whitney U tests, where appropriate, and the and the impact of pre-surgery, post-surgery, and change in biomarker will be compared across survival endpoints using log-rank tests and univariate Cox proportional hazards models.
Time frame
From baseline up to 10 years post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov