Cancer Clinical Trial
Official title:
A Pilot Study of Combined Decompressive Spine Radiosurgery and Pembrolizumab in Patients With High-Grade Epidural Disease
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.
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 (see 5.2.1). - Evaluate accrual rate, - Evaluate pain relief. - Evaluate quality of life. - Evaluate cumulative incidence of adverse events. - Evaluate potential correlative blood biomarkers. ;
| NCT number | NCT05204290 |
| Study type | Interventional |
| Source | Wake Forest University Health Sciences |
| Contact | Study Coordinator |
| Phone | 336-713-3539 |
| [email protected] | |
| Status | Recruiting |
| Phase | Early Phase 1 |
| Start date | March 28, 2022 |
| Completion date | September 2023 |
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