Sponsor: Merck
Sponsor Study ID: MK-3475-630
Study Title: A Phase 3, Randomized, Double blind, Placebo controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High risk Locally Advanced Cutaneous Squamous Cell Carcinoma
CTO #: 102937
NCT Number: NCT03833167
Phase: III
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Larynx; Lip, Oral Cavity and Pharynx; Other Skin
Study Objectives: Objective: To compare the recurrence-free survival (RFS), as assessed by the investigator and confirmed by biopsy, in individuals who receive pembrolizumab with individuals who receive placebo as adjuvant therapy. - Hypothesis (H1): Pembrolizumab as adjuvant therapy is superior to placebo with respect to RFS as assessed by the investigator.