PRIMARY OBJECTIVE:
I. To compare recurrence free survival (RFS) and overall survival (OS) as co-primary endpoints across the two arms.
SECONDARY OBJECTIVES:
I. To evaluate adverse events. II. To evaluate distant metastasis free survival (DMFS). III. To evaluate the impact of radiation on clinical outcomes (OS, RFS, DMFS).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo standard of care radiation therapy within 14 days of day 1, cycle 1. Patients undergo positron emission tomography (PET)-computed tomography (CT), CT, or magnetic resonance imaging (MRI) throughout the trial. Patients may also undergo blood and utine sample collection as clinically indicated at the discretion of the treating investigator.
ARM B: Patients receive standard of care observation every 3 months for 1 year, and then every 6 months for 5 years. Patients may also undergo standard of care radiation therapy within 14 days of day 1, cycle 1. Patients undergo PET-CT, CT, or MRI throughout the trial. Patients may also undergo blood and urine sample collection as clinically indicated at the discretion of the treating investigator.
After completion of study treatment, patients are followed up every 3-6 months for 5 years from the date of registration.
An Institutional Review Board responsible for human subjects research at The University of Arizona reviewed this research project and found it to be acceptable, according to applicable state and federal regulations and University policies designed to protect the rights and welfare of participants in research.