J1980 - 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
Johns Hopkins Kimmel Cancer Center in Baltimore
This research is being conducted to compare if patients with high risk cutaneous squamous cell carcinoma treated with Cemiplimab after surgery and radiation will remain cancer free versus those patients treated with a placebo. The study also wants to better understand, if Cemiplimab may help you live for longer; how study participation affects how you feel and the side effects that you may experience during the study.
Patients must be 18 and older with high risk CSCC. Completed radiation therapy (RT) within 2-6 weeks of randomization to the clinical trial and no toxicities greater than grade 1. No other cancer within the past 3 years except for tumors with low risk of metastasis or death are allowed. No blood cancers or patients with bone marrow transplants are allowed. No serious autoimmune diseases or prednisone use greater than 10mg per day are allowed. No live vaccine therapy within the past 28 days or prior systemic anti-cancer immunotherapy or other anti-cancer systemic therapy for CSCC are allowed. No encephalitis, meningitis, or uncontrolled seizures in the prior year or myocardial infarction within the past 6 months are allowed. No active infections, or uncontrolled HIV, Hep B or Hep C are allowed or history of immune related pneumonitis or interstitial lung disease within the last 5 years. No patients with a history of a solid organ transplants, known psychiatric or substance abuse disorders or pregnant or breastfeeding women are allowed. All subjects must have a good performance status and good organ functioning as determined by lab work.
Patients will receive either Cemiplimab 350mg IV or placebo every 3 weeks up to 48 weeks. Patients will undergo post treatment follow up until disease recurrence or end of study. If a patient has disease recurrence and is unblinded and found to be on the placebo treatment, that patient can receive Cemiplimab. If a patient receiving Cemiplimab has disease recurrence and is unblinded and found to be receiving Cemiplimab, that patient can be treated with Cemiplimab for up to 96 weeks.
08/07/2020 05:02 AM