This early phase I trial tests whether decompressive spine radiosurgery and pembrolizumab works to shrink the size of cancer that has spread near the spinal cord (epidural disease). Radiosurgery involves radiation in a large dose to destroy cancer. Radiosurgery is noninvasive, meaning it does not involve cutting the tumor out. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab after radiosurgery may reduce the amount of tumor near the spinal cord and improve pain relief.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05204290.
PRIMARY OBJECTIVE:
I. To determine the feasibility of patients completing stereotactic body radiation therapy (SBRT) and at least 1 cycle of pembrolizumab.
SECONDARY OBJECTIVES:
I. Evaluate the radiographic response after decompressive SBRT and pembrolizumab by calculating the improvement in thecal sac patency.
II. Evaluate accrual rate.
III. Evaluate pain relief.
IV. Evaluate quality of life.
V. Evaluate cumulative incidence of adverse events.
VI. Evaluate potential correlative blood biomarkers.
OUTLINE:
Patients undergo SBRT over 30 minutes for up to 5 treatments in the absence of disease progression or unacceptable toxicity. Within 6 weeks of completion of SBRT, patients receive pembrolizumab intravenously (IV) at the discretion of the treating medical oncologist.
After completion of study intervention, patients are followed up for up to 6 months after SBRT.
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorChristina Kehl Cramer
