NCT05204290

Study of Combined Decompressive Spine Radiosurgery and Pembrolizumab

A Pilot Study of Combined Decompressive Spine Radiosurgery and Pembrolizumab in Patients With High-Grade Epidural Disease

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to find out what effects (good and bad) Pembrolizumab and radiosurgery have on participants with high-grade epidural disease of the spine.

Detailed description

Primary Objective: To determine the feasibility of patients completing stereotactic body radiation therapy and at least one (1) cycle of Pembrolizumab. Secondary Objectives: * Evaluate the radiographic response after decompressive stereotactic body radiation therapy and Pembrolizumab by calculating the improvement in thecal sac patency. * Evaluate accrual rate. * Evaluate pain relief. * Evaluate quality of life. * Evaluate cumulative incidence of adverse events. * Evaluate potential correlative blood biomarkers.

Conditions

• Epidural Spinal Tumors
• Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab will be delivered at the discretion of the patient's medical oncologist within 6 weeks after finishing SBRT. If a patient is already receiving pembrolizumab at the time of enrollment, then SBRT should not start sooner than 5 days after the last pembrolizumab infusion.
RADIATION	Stereotactic Body Radiation Therapy	patients will undergo CT simulation and will be immobilized in either a BodyFix® or long thermoplastic mask depending on the location of the lesion. 1.25mm slices will be acquired. Dose and fractionation will be at the discretion of the treating radiation oncologist (as will the constraint to the spinal cord).
OTHER	Blood draws	Patients will have a blood draw at baseline and at 2-months post-SBRT, and 6 months post-stereotactic body radiation therapy.

Timeline

• Start date: 2022-03-28
• Primary completion: 2022-10-07
• Completion: 2022-10-07
• First posted: 2022-01-24
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study