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(Last updated: October 21, 2020)

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NEAREST SITE: 650 miles
Mayo Clinic
Phoenix,AZ

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04301011

Immunotherapy TBio-6517 Alone or With Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase 1/2a, Multicenter, Open-label Trial of TBio-6517, an Oncolytic Vaccinia Virus, Administered by Intratumoral Injection, Alone and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors (RAPTOR) Scientific Title

Purpose
To determine the best dose and to study the effects (good and bad) of using the immunotherapy TBio-6517 alone and in combination with the immunotherapy pembrolizumab (Keytruda®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. If your tumor is PD-L1 positive, you must have already received a PD-L1 or a PD-1 targeted therapy.    Full eligibility criteria
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  • <p class="seamTextPara"> You will participate in either Phase 1 or Phase 2: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Phase 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TBio-6517, by injection directly into your tumor, 4 times (you may also receive boosters for up to 2 years)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Phase 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TBio-6517, by injection directly into your tumor, 4 times (you may also receive boosters for up to 2 years)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TBio-6517 is an immunotherapy that is injected directly into your tumor.</li> <li class="seamTextUnorderedListItem">TBio-6517 is an experimental drug, this means it is only available in clinical trials.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking PD-1. It is approved for use in some cancers but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04301011' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://turnstonebio.com/#about-us' target='_blank'>Turnstone Biologics Drug Information Page: TBio-6517 (RIVAL-01)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Drug Information Page: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/keytruda-plus-chemo-better-than-chemo-alone-for-some' target='_blank'>Breastcancer.org: Keytruda Plus Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>
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