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(Last updated: October 24, 2020)

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NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: At least 1 visit per month for 6 months

PHASE: I

NCT ID: NCT03970382

Personalized Immunotherapy With or Without Opdivo for Metastatic Hormone Positive Breast Cancer

A Phase 1a/1b, Open-label First-in-human Study of the Safety, Tolerability and Feasibility of Gene-edited Autologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination With Anti-PD-1 to Patients With Locally Advanced or Metastatic Solid Tumors Scientific Title

Purpose
To determine the safety and the effects (good or bad) of an experimental T-cell immunotherapy called neoTCR-P1 when it is given with or without nivolumab (Opdivo®).
Who is this for?
People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+) breast cancer that has been treated with at least one standard therapy.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NeoTCR-P1, one time </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NeoTCR-P1, one time </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), once a month, for 6 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NeoTCR-P1 makes a patient's T-cells target a neoepitope (neoE) that is found on their cancer cells. </li> <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). It has been approved to treat certain types of cancer. 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/NCT03970382' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/798453' target='_blank'>NCI Drug Dictionary: gene-edited autologous neoantigen-targeted NeoTCR-P1 T cells</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/nivolumab' target='_blank'>NCI Drug Dictionary: Nivolumab</a> </li></ul>
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