Cemiplimab before and after Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer

Active:	Yes
Cancer Type:	Skin Cancer (Non-Melanoma) Unknown Primary	NCT ID:	NCT04428671
Trial Phases:	Phase I	Protocol IDs:	Winship4851-19 (primary) NCI-2019-07373 IRB00115160
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT04428671

Summary

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.

Objectives

PRIMARY OBJECTIVE:
I. To establish the pathologic response rate of neoadjuvant cemiplimab in cutaneous squamous cell carcinoma (cSCC).

SECONDARY OBJECTIVES:
I. To document the local recurrence rate of high-risk cSCC treated with adjuvant cemiplimab.
II. To document the systemic recurrence rate of high-risk cSCC treated with adjuvant cemiplimab.
III. To document the 6-month, 12-month, 2-year overall survival (OS), recurrence-free survival (RFS) for patients with high risk cSCC.

TERTIARY/EXPLORATORY OBJECTIVE:
I. To evaluate the immune profile of fresh tumor tissue, blood in patients with cSCC treated with cemiplimab.

OUTLINE:

NEOADJUVANT PHASE: Prior to standard of care surgery, patients receive cemiplimab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI within 7 days of surgery.

ADJUVANT PHASE: Within 2-6 weeks after completion of standard of care radiation therapy (or surgery if no radiation therapy), patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 3 months following cycle 4 until the end of treatment.

After completion of study treatment, patients are followed up every 12 weeks for 2 years, every 6 months for the next 3 years, and then annually for up to 10 years.

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