Study of Combined Decompressive Spine Radiosurgery and Pembrolizumab (NCT05204290) | Clinical Trial Compass
TerminatedEarly Phase 1
Study of Combined Decompressive Spine Radiosurgery and Pembrolizumab
Stopped: Low accruals
United States1 participantsStarted 2022-03-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria :
* Pathologic diagnosis of cancer, confirmed by review of pathology report.
* Epidural disease seen on MRI at 1 vertebral level or 2 contiguous vertebral level.
* Synchronous and metachronous sites of disease allowed.
* Patient with expected life span of ≥ 3 months.
* Deemed eligible for stereotactic body radiation therapy and pembrolizumab after multi-disciplinary review. The multi-disciplinary review will be conducted virtually via our Spinal Oncology Group (SPOG) Wake Forest e-mail listserv. Members of the distribution list include neurosurgeons, orthopedic surgeons, interventional radiologists, radiologists, and radiation oncologists. This group meets monthly via Webex and in the interim, cases are routinely reviewed using encrypted emails via the listserv. Because we will not be able to wait for a month meeting to enroll patients on study, we anticipate needing to review these patients via the listserv. The electronic review will serve as documentation of multi-disciplinary review.
* Patients currently being treated with pembrolizumab or anticipated to receive at least one dose of pembrolizumab within six weeks after finishing stereotactic body radiation therapy.
* Patients who have received prior immunotherapy are allowed.
* Age equal or greater than 18.
* Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
Exclusion Criteria:
* Prior radiation th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Completing Stereotactic Body Radiation Therapy (SBRT) and One Cycle of Pembrolizumab