Trial Outcomes & Findings for Study of Combined Decompressive Spine Radiosurgery and Pembrolizumab (NCT NCT05204290)
NCT ID: NCT05204290
Last Updated: 2026-06-29
Results Overview
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.
TERMINATED
EARLY_PHASE1
1 participants
At Day 5 and up to cycle 1 (Day 22)
2026-06-29
Participant Flow
The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Participant milestones
| Measure |
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
Pembrolizumab: 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: 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: Patients will have a blood draw at baseline and at 2-months post-SBRT, and 6 months post-stereotactic body radiation therapy.
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Combined Decompressive Spine Radiosurgery and Pembrolizumab
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: At Day 5 and up to cycle 1 (Day 22)Population: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, at 2 months and 6 months after interventionPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
The percentage of thecal sac patency, which will be calculated as the ratio of the thecal sac area at the level of greatest epidural disease to the estimated pre-compression thecal sac area. The estimated pre-compression thecal sac area will be calculated by averaging the area of the thecal sac at one spinal level above and one spinal level below the level of the compression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 2 months, up to 6 monthsPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Number of enrolled per month on the study intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, at 2 months and 6 months after interventionPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Using the Numeric Pain Rating Scale the number of participants that experience a clinically significant improvement in pain defined as either a 33% decrease in pain score or an absolute decrease from baseline of 2 points. Scores range from 0-10 points, with higher scores indicating greater pain intensity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, at 2 months and 6 months after interventionPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
The 22-item EORTC QLQ-BM22 questionnaire assesses disease symptoms related to bone metastasis, including painful sites, functional interference, painful characteristics, and psychosocial aspects as multi-item scales. Scaled items from one (not at all) to four (very much). Score range is from 0 to 100. A higher score in the case of symptom scales is indicative of greater distress, while a higher score in the case of functional scales indicates greater functional ability.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month after intervention and 6 months after interventionPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
New or worsening after stereotactic body radiation therapy, rate of pain flare by physician assessment and cumulative incidences of radiation myelitis will be assessed. Radiation myelitis will be defined by the study PI using clinical and radiographic techniques will be calculated. For discrete variables, the proportions and counts will be calculated for each visit. For continuous variables, means, standard deviations, medians, the first quartiles, the third quartiles, and ranges will be calculated for each visit. The 95% confidence intervals will be also estimated
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, 2 months and 6 months after interventionPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Plasma will be tested for histamine, Calcitonin gene-related peptide (CGRP), and substance P which will characterize bone turnover markers, specifically for N-terminal propeptide of type 1 procollagen (P1NP; bone formation) and C-terminal telopeptide of type 1 collagen (CTX; bone resorption). For discrete variables, the proportions and counts will be calculated for each visit. For continuous variables, means, standard deviations, medians, the first quartiles, the third quartiles, and ranges will be calculated for each visit. The 95% confidence intervals will be also estimated
Outcome measures
Outcome data not reported
Adverse Events
Stereotactic Body Radiotherapy and Pembrolizumab Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Christina K. Cramer, MD
Wake Forest University Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place