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(Last updated: November 29, 2020)

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NEAREST SITE: 2385 miles
Duke University Medical Center
Durham,NC

VISITS: 1 visit

PHASE: II

NCT ID: NCT04434560

Immunotherapy Before Surgery for Triple Negative Brain Metastases that are PD-L1 Positive

A Randomized Phase II Trial of Surgery and Stereotactic Radiosurgery With and Without Neoadjuvant Nivolumab and Ipilimumab in Patients With Surgically-resectable, Solid Tumor Brain Metastases Scientific Title

Purpose
To study the safety and anti-cancer activity of giving a combination of two immunotherapies before surgery and radiation therapy.
Who is this for?
People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that is PD-L1 positive and has metastasized (spread) to the brain. You must have no more than 3 untreated brain metastases and be planning to have surgery and radiation therapy.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups and receive the following before surgery for brain metastases: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, once, about 1 week before surgery</li> <li class="seamTextUnorderedListItem">Ipilimumab (Yervoy®), by IV, once, about 1 week before surgery</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No therapies before surgery for brain metastases</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Opdivo is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). </li> <li class="seamTextUnorderedListItem">It has been approved to treat certain types of cancer but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Ipilimumab (Yerovy®) is a type of immunotherapy called a CTLA-4 inhibitor. It is approved for use in other cancers but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancers that have spread (metastasized) to the brain. </li> <li class="seamTextUnorderedListItem">Targets or mutations: PD-L1</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04434560' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/targeting-sanctuary-site-options-when-breast-cancer-metastasizes-brain' target='_blank'>CancerNetwork: Targeting the Sanctuary Site</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2018/melanoma-brain-metastases-nivolumab-ipilimumab' target='_blank'>NCI, Cancer Currents Blog: Nivolumab and Ipilimumab Effective against Melanoma That Has Spread to the Brain</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncnursingnews.com/web-exclusives/more-immunotherapy-may-enter-tnbc-space' target='_blank'>Oncology Nursing News: More Immunotherapy May Enter TNBC Space</a> </li></ul>
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