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(Last updated: November 13, 2019)

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NEAREST SITE: 1643 miles
University of Texas MD Anderson Cancer Center
Houston,TX

VISITS: Hospital stay for 1 week; 4 visits in the first month; then 1 visit every 3 weeks for up to 1 year

PHASE: I

NCT ID: NCT03435952

Keytruda plus Bacterial Therapy for Advanced Breast (and Other) Tumors

A Phase Ib Investigation of Pembrolizumab in Combination With Intratumoral Injection of Clostridium Novyi-NT in Patients With Treatment-Refractory Solid Tumors Scientific Title

Purpose
To study the safety, effects (good and bad) and best dose of a type of bacteria that researchers believe will prime tumors to respond to an immunotherapy.
Who is this for?
Women and men with advanced (some stage III) or metastatic (stage IV) breast cancer.    Full eligibility criteria
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  • What's being studied?
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bacterial therapy (Clostridium Novyi-NT), by injection, once, on Day 8, during 1-week hospital stay</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, for up to 1 year</li> <li class="seamTextUnorderedListItem">Doxocyclin, by mouth, 2 times a day for the rest of your life to lower the risk of further growth of Clostridium novyi-NT</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The bacteria have been modified to remove the chemicals that are poisonous to humans. </li> <li class="seamTextUnorderedListItem">The bacterial therapy being used in this study is clostridium novyi-NT. </li> <li class="seamTextUnorderedListItem">The immunotherapy being used in this study is the PD-1 inhibitor pembrolizumab (Keytruda®). </li> <li class="seamTextUnorderedListItem">Keytruda stimulates the body's immune system to go after cancer cells. It is approved to treat select types of cancers. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">You will also receive the antibiotic, doxocyclin. It is given to help keep the growth of the bacteria clostridium novyi-NT under control.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03435952' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/clostridium-novyi-nt-spores' target='_blank'>NCI Drug Dictionary: Clostridium novyi-NT</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sciencedirect.com/science/article/pii/S2352304216000064' target='_blank'>Genes & Diseases: Clostridium novyi-NT in Cancer Therapy</a> </li></ul>
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