Combining spine radiosurgery with Pembrolizumab for cancer treatment

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

This study is testing if combining a cancer drug called Pembrolizumab with targeted radiation therapy can help patients with serious spinal tumors feel better and improve their quality of life.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Wake Forest University Health Sciences (other)
• Drugs / interventions: pembrolizumab, immunotherapy, radiation
• Locations: 1 site (Winston-Salem, North Carolina)
• Trial ID: NCT05204290 on ClinicalTrials.gov

What this trial studies

This research investigates the effects of Pembrolizumab and stereotactic body radiation therapy on patients with high-grade epidural spinal tumors. The primary goal is to assess the feasibility of patients completing the treatment regimen, which includes at least one cycle of Pembrolizumab. Secondary objectives involve evaluating radiographic responses, pain relief, quality of life, and the incidence of adverse events, along with potential blood biomarkers. The study is conducted by a multi-disciplinary team to ensure comprehensive patient evaluation.

Who should consider this trial

Good fit: Ideal candidates include patients with a confirmed diagnosis of cancer and epidural disease affecting one or two contiguous vertebral levels.

Not a fit: Patients with a life expectancy of less than three months or those not eligible for the proposed treatments will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with epidural spinal tumors.

How similar studies have performed: While the combination of these specific treatments is novel, similar approaches in cancer treatment have shown promise in other studies.

Eligibility criteria

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 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.

Where this trial is running

Winston-Salem, North Carolina

• Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Christina K Cramer, MD — Wake Forest Baptist Health Sciences
• Study coordinator: Study Coordinator

Conditions: Epidural Spinal Tumors, Cancer