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Monoclonal Antibodies

Pembrolizumab + Spine Radiosurgery for Spinal Tumors

Phase < 1
Recruiting
Led By Christina K Cramer, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologic diagnosis of cancer, confirmed by review of pathology report
Epidural disease seen on MRI at 1 vertebral level or 2 contiguous vertebral levels
Must not have
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
Patients with lymphoma, multiple myeloma, germinomas, seminomas, Wilm's tumors, and Ewing's sarcomas will be excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 months, up to 20 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment, Pembrolizumab, in combination with radiosurgery for people with high-grade epidural disease of the spine.

Who is the study for?
This trial is for adults over 18 with a confirmed cancer diagnosis affecting the spine, who have an expected lifespan of at least 3 months. They should be eligible for radiation therapy and pembrolizumab treatment, and may already be on or scheduled to start pembrolizumab soon. Excluded are those with contraindications to pembrolizumab, other ongoing trials, symptomatic brain metastases that affect neurological assessments, severe illnesses or conditions that could interfere with the study, pregnant women, prior treatments to the lesion area, certain types of tumors like lymphoma or multiple myeloma.
What is being tested?
The study investigates the combined effect of Stereotactic Body Radiation Therapy (a precise high-dose radiation treatment) and Pembrolizumab (an immunotherapy drug) on patients with advanced spinal cancer. The goal is to assess how well these treatments work together in controlling disease progression in the spine.
What are the potential side effects?
Pembrolizumab can cause immune system-related side effects such as inflammation in various organs including lungs and intestines; skin reactions; hormone gland problems; infusion-related reactions; fatigue; liver issues. Radiation therapy might lead to localized skin irritation and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer diagnosis has been confirmed by a pathology report.
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My MRI shows epidural disease at 1 or 2 connected spine levels.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I do not have lymphoma, multiple myeloma, germinomas, seminomas, Wilm's tumors, or Ewing's sarcomas.
Select...
I have a specific type of spinal fracture.
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I am not pregnant or breastfeeding.
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I cannot take pembrolizumab due to health reasons.
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I have had radiation or surgery on my main cancer lesion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 months, up to 20 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 months, up to 20 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Completing Stereotactic Body Radiation Therapy and One Cycle of Pembrolizumab
Secondary study objectives
Accrual Rate
Change Thecal Sac Patency - (Percentage)
Plasma Exchange
+3 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446
87%
Fatigue
53%
Nausea
33%
Cough
27%
Pain
27%
Fall
27%
Dyspnea
27%
Depression
27%
Lymphocyte count decreased
27%
Platelet count decreased
27%
Anemia
20%
Dizziness
20%
Chills
20%
Edema limbs
20%
Chest pain
20%
Neutropenia
20%
Diarrhea
13%
Dysesthesia
13%
Edema
13%
Insomnia
13%
Constipation
13%
Delirium
13%
Dysgeusia
13%
Myalgia
13%
Skin infection
13%
Vomiting
13%
Tinnitus
13%
Rash
13%
Back pain
13%
Weakness (limb)
13%
Weight loss
7%
Bruising
7%
Hearing loss
7%
Anxiety
7%
Headaches
7%
Oral lesions
7%
Weakness (facial)
7%
Neutrophil count decreased
7%
Acute kidney injury
7%
Hypokalemia
7%
Lymphocytopenia
7%
Seizures
7%
Hearing impaired
7%
Hypernatremia
7%
Creatinine increased
7%
Headache
7%
Death NOS
7%
Gait disturbance
7%
Nasal congestion
7%
Fever
7%
Tremor
7%
Urinary urgency
7%
Hypoxic respiratory failure
7%
Amnesia
7%
Photophobia
7%
Pleural effusion
7%
Urinary frequency
7%
Dysphagia
7%
Low white blood count
7%
Sneezing
7%
Cognitive disturbance
7%
Erythema multitforme
7%
Lung infection
7%
Hypertension
7%
Allergy (seasonal)
7%
Muscle weakness
7%
Proteinuria
7%
Hypomagnesemia
7%
Parathesia (tingling)
7%
Febrile Neutropenia
7%
Anorexia
7%
Sleep apnea
7%
Encephalopathy
7%
Hypoxia
7%
Shingles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Chemotherapy
Stereotactic Body Radiation Therapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Stereotactic Body Radiotherapy and Pembrolizumab TreatmentExperimental Treatment3 Interventions
MRI scans of your spine (before treatment, 2 months after treatment, and 6 months after treatment) and immunotherapy with Pembrolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,395 Previous Clinical Trials
2,460,195 Total Patients Enrolled
Christina K Cramer, MDPrincipal InvestigatorWake Forest Baptist Health Sciences
1 Previous Clinical Trials
244 Total Patients Enrolled
~0 spots leftby Dec 2024
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