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Monoclonal Antibodies

Stereotactic Radiosurgery for Brain Metastasis

Phase 1

Waitlist Available

Led By Mohammad K. Khan, MD, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to up to 3 years

Awards & highlights

Study Summary

This trial is studying the side effects of pembrolizumab given with stereotactic radiosurgery to treat patients with melanoma or non-small cell lung cancer that has spread to the brain.

Eligible Conditions

Brain Metastasis
Melanoma
Eye Melanoma
Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of dose limiting toxicities defined as Radiation Therapy Oncology Group grade 3 central nervous system toxicities which are irreversible severe neurological symptoms requiring medications

Secondary outcome measures

Frequency and absolute cell counts for pre and post treatment serum immune biomarkers

Overall response (intra-cranial and extra-cranial) assessed using RECIST and immune RECIST Criteria

Overall survival

+4 more

Side effects data

From 2019 Phase 2 trial • 32 Patients • NCT01573702

32%

Fatigue

28%

Lymphocyte count decreased

24%

Cough

20%

Back pain

20%

Rash acneiform

16%

Anorexia

16%

Dry skin

16%

Hyperglycemia

16%

Rash maculo-papular

12%

Aspartate aminotransferase increased

12%

Non-cardiac chest pain

12%

Diarrhea

12%

Dyspepsia

12%

Headache

12%

Nausea

12%

Pain

12%

Pain in extremity

Wheezing

Watering eyes

Urinary tract pain

Myalgia

Weight loss

Arthralgia

Edema limbs

Abdominal pain

Paronychia

Pruritus

Blurred vision

Skin and subcutaneous tissue disorders - Other, specify

Upper respiratory infection

White blood cell decreased

Sore throat

Urinary tract infection

Skin infection

Lethargy

Infusion site extravasation

Urinary urgency

Vomiting

Insomnia

Ear pain

Oral hemorrhage

Conjunctivitis

Alkaline phosphatase increased

Blood bilirubin increased

Bone pain

Bruising

Depression

Dry eye

Dysgeusia

Dysphagia

Edema face

Epistaxis

Flashing lights

Flu like symptoms

Gastroesophageal reflux disease

Hot flashes

Hyperkalemia

Hypernatremia

Nail loss

Nail ridging

Neck pain

Neutrophil count decreased

Papulopustular rash

Platelet count decreased

Pneumonitis

Fracture

Fall

Skin hyperpigmentation

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Radiosurgery Followed by Erlotinib

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C (pembrolizumab, SRS 18-21 Gy)Experimental Treatment2 Interventions

Patients receive pembrolizumab IV as in Arm A. Patients undergo 1 SRS fraction between days 2-3 of course 1.

Group II: Arm B (pembrolizumab, SRS 9 Gy)Experimental Treatment2 Interventions

Patients receive pembrolizumab IV as in Arm A. Patients undergo 3 SRS fractions between days 2-15 of course 1.

Group III: Arm A (pembrolizumab, SRS 6 Gy, CLOSED):Experimental Treatment2 Interventions

Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat Q3W for at least 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo 5 SRS fractions between days 2-15 of course 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Stereotactic Radiosurgery

2016

Completed Phase 2

~460

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,544 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,126 Total Patients Enrolled

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,546 Total Patients Enrolled

Media Library

Brain Metastasis Research Study Groups: Arm C (pembrolizumab, SRS 18-21 Gy), Arm A (pembrolizumab, SRS 6 Gy, CLOSED):, Arm B (pembrolizumab, SRS 9 Gy)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions has Stereotactic Radiosurgery been found to be effective in ameliorating?

"Stereotactic Radiosurgery is most frequently employed as a treatment for malignant neoplasms, yet it can also be beneficial in managing unresectable melanoma, microsatellite instability high cases, and disease progression post-chemotherapy."

Answered by AI

How many participants are enrolled in this research endeavor?

"This medical research is not currently open to new enrolments. It was first posted in October 2016 and had its most recent update on the 2nd of November 2022. Currently, there are 5051 studies seeking participants with brain-related issues, as well as 963 trials actively recruiting patients for Stereotactic Radiosurgery."

Answered by AI

What has the FDA concluded regarding Stereotactic Radiosurgery's efficacy?

"With only limited supporting data, Stereotactic Radiosurgery is estimated to have a safety rating of 1. This assessment is based on the fact that this trial is still in its first phase."

Answered by AI

Are there any openings available for participants in this research trial?

"This particular trial has since closed, but other studies are recruiting. For those looking to take part in trials involving the brain, there are 5051 active opportunities; whereas 963 enrolment spots remain open for Stereotactic Radiosurgery."

Answered by AI

Could you provide me with a summary of the prior experiments related to Stereotactic Radiosurgery?

"Currently, there are 963 clinical trials studying the effects of Stereotactic Radiosurgery with 122 in Phase 3. With Houston being the epicentre for these studies, 35772 distinct locations across the globe have active research initiatives into this medical procedure."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab and Stereotactic Radiosurgery for Melanoma or Non-Small Cell Lung Cancer Brain Metastases

Mohammad K. Khan 2016. "Pembrolizumab and Stereotactic Radiosurgery for Melanoma or Non-Small Cell Lung Cancer Brain Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02858869.

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