Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-20-117
Prinicipal Investigator
Machtay, Mitchell
Phase
Phase II/III
Age Group
Adult
Scope
Local
Secondary Protocol No.
RTOG 3507
Title
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.
Applicable Disease Sites
Head and Neck
Status
Open
Participating Institutions
Hershey Medical Center