Study of Combined Decompressive Spine Radiosurgery and Pembrolizumab

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05204290
Phase
EARLY_PHASE1
Status
Terminated

Conditions

  • Cancer
  • Epidural Spinal Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    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.
  • Stereotactic Body Radiation Therapy — RADIATION
    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).
  • Blood draws — OTHER
    Patients will have a blood draw at baseline and at 2-months post-SBRT, and 6 months post-stereotactic body radiation therapy.

Study Details

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.

Key Dates

Start date
Mar 28, 2022
Status verified
Mar 2026
Primary completion
Oct 7, 2022
Completion
Oct 7, 2022

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Stereotactic Body Radiotherapy and Pembrolizumab Treatment
    MRI scans of your spine (before treatment, 2 months after treatment, and 6 months after treatment) and immunotherapy with Pembrolizumab

Primary Outcome Measure

Number of Participants Completing Stereotactic Body Radiation Therapy (SBRT) and One Cycle of Pembrolizumab [ Time Frame: At Day 5 and up to cycle 1 (Day 22) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-

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By research site
Wake Forest Baptist Comprehensive Cancer Center· Winston-Salem, NC

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