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(Last updated: October 21, 2020)

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NEAREST SITE: 2385 miles
Duke University
Durham,NC

VISITS: Visits every 2 weeks for 6 weeks and/or every 3 weeks for 4 months

PHASE: II

NCT ID: NCT03632941

A Cancer Vaccine and Pembrolizumab for Advanced HER2 Positive Breast Cancer

A Phase II Randomized Study to Evaluate the Immunologic and Antitumor Activity of Concurrent VRP-HER2 Vaccination and Pembrolizumab for Patients With Advanced HER2-overexpressing Breast Cancer Scientific Title

Purpose
To compare the safety and effects (good and bad) of using the investigational tumor vaccine VRP-HER2 alone, to pembrolizumab (Keytruda®) alone, and to both treatments together.
Who is this for?
People with recurrent or advanced (some stage III) or metastatic (stage IV) HER2 positive breast cancer.    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VRP-HER2 (AVX901), by injection, once every 2 weeks, for 6 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks, for 4 months </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VRP-HER2 (AVX901), by injection, once every 2 weeks, for 6 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks, for 4 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures: 2 biopsies</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The VRP-HER2 cancer vaccine is designed to activate the immune system to go after HER2 positive cancer cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PDL-1 inhibitor. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03632941' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/her2-ecdtm-virus-like-replicon-particles-vaccine-avx901' target='_blank'>NCI Drug Dictionary: HER2 ECD+TM virus-like replicon particles vaccine AVX901</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5645504/' target='_blank'>Frontiers Endocrinology: Breast Cancer Vaccines: New Insights</a> </li></ul>
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