Study of Combined Decompressive Spine Radiosurgery and Pembrolizumab

NCT05204290 | Terminated Early Phase 1 DMC FDA Drug

• 3 other identifiers: IRB00078836WFBCCC 03321P30CA012197
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epidural Spinal Tumors; Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants Completing Stereotactic Body Radiation Therapy (SBRT) and One Cycle of Pembrolizumab

  A 95% confidence interval for the primary outcome, the feasibility of patients completing stereotactic body radiation therapy and at least one cycle of Pembrolizumab, will be calculated.

  At Day 5 and up to cycle 1 (Day 22)

Secondary Outcomes (6)

• Change in Thecal Sac Patency - (Percentage)

  At baseline, at 2 months and 6 months after intervention

• Accrual Rate

  Every 2 months, up to 6 months

• Number of Participants Experiencing Improvement in Pain - Numeric Pain Rating Scale (NPRS)

  At baseline, at 2 months and 6 months after intervention

• Quality of Life - European Organization for Research and Treatment of Cancer QoL Group Bone Metastases Module (QLQ-BM22)

  At baseline, at 2 months and 6 months after intervention

• Incidences of Compression Fractures

  1 month after intervention and 6 months after intervention

Study Arms (1)

Stereotactic Body Radiotherapy and Pembrolizumab Treatment

EXPERIMENTAL

MRI scans of your spine (before treatment, 2 months after treatment, and 6 months after treatment) and immunotherapy with Pembrolizumab

Drug: Pembrolizumab; Radiation: Stereotactic Body Radiation Therapy; Other: Blood draws

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 Radiotherapy and Pembrolizumab Treatment

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).

Stereotactic Body Radiotherapy and Pembrolizumab Treatment

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.

Stereotactic Body Radiotherapy and Pembrolizumab Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Prior radiation therapy or surgery to index lesion.
• Patients with lymphoma, multiple myeloma, germinomas, seminomas, Wilm's tumors, and Ewing's sarcomas will be excluded.
• Muscle strength of ≤ 3 out of 5 on neurologic exam that correlates with level of the involved spinal cord.
• Retropulsed compression fracture.
• Patients with a contraindication to pembrolizumab.
• Patients may not be receiving any other investigational agents.
• Patients with symptomatic, brain metastases, as determined by the study PI, that could confound the neurologic exam, should be excluded.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because both radiation and pembrolizumab can be harmful to the developing fetus. Because there is an unknown but potential risk for adverse events, pregnant women are not allowed to participate in this study, in nursing infants secondary to treatment of the mother with pembrolizumab, breastfeeding should be discontinued.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Epidural Neoplasms; Neoplasms

Interventions

pembrolizumab; Radiosurgery; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Spinal Cord Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures

Study Officials

• Christina K Cramer, MD

  Wake Forest Baptist Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: March 28, 2022
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)