Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

Trial ID or NCT#

NCT03969004

Status

not recruiting iconNOT RECRUITING

Purpose

The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study are: * To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT * To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT * To assess cemiplimab pharmacokinetics and immunogenicity in human serum

Official Title

A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

Investigator(s)

Vasu Divi, MD
Vasu Divi, MD
Head and neck surgeon, Surgical oncologist, Cutaneous oncology specialist
Associate Professor of Otolaryngology - Head & Neck Surgery (OHNS)
Anne Lynn S Chang
Dermatologist, General dermatologist, Dermatologic oncologist, Cutaneous oncology specialist
Professor of Dermatology

Contact us to find out if this trial is right for you.

Contact

Denise Haas
650-498-5150