34
Participants
Start Date
October 6, 2022
Primary Completion Date
October 6, 2026
Study Completion Date
October 6, 2026
Cemiplimab
Participants will undergo baseline imaging, followed by two doses of neoadjuvant cemiplimab at a dose of 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days). Then, participants will receive concurrent cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) concurrently with RT to 70 Gy in 35 fractions over 7 weeks. Thereafter, participants will receive 38 weeks of cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) for a cumulative total of 12 months of cemiplimab.
Radiotherapy
Participants will receive radiotherapy to 70 Gy in 35 fractions over 7 weeks concurrently with cemiplimab
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York
Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison
Memorial Sloan Kettering Nassau (All protocol activities), Rockville Centre
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities), Commack
Fox Chase Cancer Center (Data Collection Only), Philadelphia
Medical University of South Carolina, Charleston
Moffitt Cancer Center (Data Collection Only), Tampa
Cleveland Clinic (Data Collection Only), Cleveland
University of Colorado (Data Collection Only), Aurora
University of Washington (Data Collection Only), Seattle
Memorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities), Basking Ridge
Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown
Memorial Sloan Kettering Bergen (All protocol activities), Montvale
Memorial Sloan Kettering Cancer Center
OTHER