KEYSTROKE: A Randomized Phase II Study of Pembrolizumab (KEYTRUDA?) Plus Stereotactic Re-irradiation Versus SBRT Alone for Locoregionally Recurrent or Second Primary Head and Neck Carcinoma
Objective
To evaluate the safety of the addition of pembrolizumab (anti PD-1 immunotherapy) to re-irradiation with SBRT for patients with recurrent or new second primary head and neck squamous cell carcinoma
Primary Objective for Phase II Trial To compare progression-free survival (PFS) for patients with recurrent or new second primary head and neck squamous cell carcinoma with SBRT re-irradiation with or without pembrolizumab
Secondary Objectives for Phase II Trial (11-MAR-2019) To compare overall survival (OS) for patients with recurrent or new second primary head and neck squamous cell carcinoma with SBRT re-irradiation with or without pembrolizumab; To compare safety and toxicity in patients treated with SBRT re-irradiation with or without pembrolizumab; To determine the radiographic response rate, PFS and OS in patients who receive cross-over treatment to pembrolizumab following disease progression on SBRT alone; Correlative: Tumor biopsy specimens will be used to examine: 1) the presence of high density of tumor infiltrating immune cells defined by the multiplex immunohistochemical staining; 2) the presence of T cell-inflamed phenotype defined by the 12-gene cytokine signature; 3) the presence of a genetic alteration profile that associates with PD-1 inhibitor sensitivity. These correlative study data will be associated with clinical outcome measures.