Cancer Type: Cutaneous
Study Type: Treatment
Phase: Phase II
Principal Investigator: Khushalani, Nikhil
A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination with RP1 in Patients with Advanced Cutaneous Squamous Cell Carcinoma
To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) according to central review.
The primary objective of this study is to estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), as assessed by overall response rate (ORR) according to central review. The secondary objectives of the study are: To estimate ORR for patients with locally advanced CSCC To estimate ORR for patients with metastatic CSCC To estimate ORR according to investigator review To estimate ORR for patients having previously received systemic CSCC-directed therapy To estimate ORR for patients not having previously received systemic CSCC-directed therapy To estimate the duration of response (DOR) by central and investigator review To estimate progression-free survival (PFS) by central and investigator review To estimate the complete response (CR) rate by central and investigator review To estimate overall survival (OS) To estimate the disease-specific survival (DSS) To estimate the 3 year survival To assess the safety and tolerability of cemiplimab alone and combined with RP1 To assess the change of cemiplimab and cemiplimab combined with RP1 on quality of life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)
Immunotherapy; Therapy (NOS)
Cemiplimab (); REGN2810 (Cemiplimab); RP1 ()
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