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Checkpoint Inhibitor

Radiosurgery + Immunotherapy for Breast Cancer Brain Metastases

Phase 1
Waitlist Available
Led By Kamran Ahmed, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
10 or less brain metastases eligible for SRS to brain metastases or to the post-operative bed
Breast cancer with brain metastases, as documented by extracranial tumor biopsy with MRI brain imaging or intracranial surgical pathology revealing brain metastases
Must not have
Medical history of testing positive for HIV or AIDS. No HIV testing is required, unless mandated by a local health authority.
History of allergy or hypersensitivity to any of the study drugs or study drug components
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3, 6 and 12 months post treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether adding radiosurgery to immunotherapy treatment will improve response rates in patients with metastatic breast cancer that has spread to the brain.

Who is the study for?
This trial is for adults with breast cancer that has spread to the brain. They must have had prior chemotherapy, no more than 10 brain metastases suitable for stereotactic radiosurgery (SRS), and a good performance status. Pregnant or breastfeeding women, those with leptomeningeal disease, previous whole-brain radiation therapy, certain viral infections, or inadequate organ function are excluded.
What is being tested?
The study tests if giving SRS after Nivolumab improves tumor response in patients with metastatic breast cancer in the brain. It aims to see whether this combination can better manage brain tumors compared to current treatments.
What are the potential side effects?
Potential side effects include typical reactions from immunotherapy like fatigue, skin issues, inflammation of organs (like lungs or intestines), and possible complications from radiation such as headaches or temporary hair loss at treatment sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have 10 or fewer brain tumors eligible for targeted radiation.
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My breast cancer has spread to my brain, confirmed by a biopsy and MRI.
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My largest brain tumor is 4 cm or smaller.
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I am 18 years old or older.
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I have been treated with taxane and possibly anthracyclines.
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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of testing positive for HIV or AIDS.
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I am not allergic to any of the drugs or their components used in this study.
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I have had whole brain radiation therapy before.
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My blood counts are low.
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I am not pregnant or breastfeeding.
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My cancer has spread to the lining of my brain and spinal cord.
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I need extra oxygen to help me breathe.
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I have previously received immunotherapy targeting specific immune checkpoints.
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I have lung disease that causes symptoms or could affect lung-related side effects from treatment.
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My liver isn't working well.
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My pancreas is not working properly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3, 6 and 12 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3, 6 and 12 months post treatment 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 who experience Dose Limiting Toxicities
Secondary study objectives
Evaluation of intracranial distant brain tumor following treatment
Brain
Extracranial Progression Free Survival (PFS)
+2 more

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: Nivolumab followed by stereotactic radiosurgery (SRS)Experimental Treatment2 Interventions
480 mg Nivolumab will be given intravenously every 4 weeks, followed by SRS the week after the initial dose of Nivolumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2021
Completed Phase 2
~440
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
564 Previous Clinical Trials
144,869 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,691 Previous Clinical Trials
4,097,574 Total Patients Enrolled
Kamran Ahmed, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
3 Previous Clinical Trials
156 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03807765 — Phase 1
Brain Tumor Research Study Groups: Nivolumab followed by stereotactic radiosurgery (SRS)
Brain Tumor Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03807765 — Phase 1
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03807765 — Phase 1
~2 spots leftby Dec 2025
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