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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

  • Protocol Number: 201905156
  • Principal Investigator: Ansstas, George
  • Cancer Types: Head & Neck, Melanoma & Skin

Learn more about this study at: clinicaltrials.gov

For more information on this trial, contact us here:

Phone
800-600-3606
Email
[email protected]

Brief Summary

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

Protocol Interventions

Cemiplimab, Placebo