Head and Neck Clinical Trials

Merck MK-3475-689-03

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)

Physician & Study Coordinator

Physician

Dr. Dhwani Pandya

Study Coordinator

Angela Rankin RN
484-658-1792

Angela.Rankin@sluhn.org

Synopsis

Synopsis: The purpose of this Study is to test the safety of the study drug, pembroluzimab (MK-3475), and test how your cancer responds to one of the following: pembroluzimab plus radiation therapy (RT) with or without cisplatin after surgery or RT with or without cisplatin after surgery.

Eligibility Criteria

Is ≥18 years of age, at the time of signing the informed consent
Histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma - Clinical stage III oropharyngeal p16 positive that is T4 (N0-N2) M0, OR stage III or IVA oropharyngeal p16 negative, OR Stage III or IVA larynx, hypopharynx, oral cavity (independent of p16)
Patients must be eligible for primary surgery as validated by members of a multidisciplinary team
PD-L1 testing will be confirmed by a central lab during screening