A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
The purpose of this study is to compare any good and bad effects of using pembrolizumab (the study drug) along with the usual surgery and radiation plus chemotherapy with or without cisplatin to using the usual surgery and radiation plus chemotherapy approach alone with or without cisplatin
Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
Male/Female participants of at least 18 years of age
18 - 120
Healthy Volunteers Needed
Duration of Participation
Participants in Group A will receive the study drug for about 1 year as long as their cancer does not get worse or have side effects. Participants in Group B will receive the standard care for 4 months as long as their cancer does not get worse or have side effects.
You will be asked to come in for a safety follow-up visit about 30 days after stopping treatment. Once you complete the safety follow-up visit, and if your cancer has not progressed, your disease condition will be monitored by imaging scans for about the next 5 years. Scans will be obtained about once every 12 weeks for the first 3 years and about once every six months for the next 2 years.
Knight Cancer Institute Clinical Trials
Merck Sharp & Dohme Corp