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(Last updated: October 21, 2020)

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NEAREST SITE: 1853 miles
Rush University Cancer Center
Chicago,IL

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03544723

Gene Therapy Ad-p53 In Combination With Immunotherapy for Advanced Breast Cancer

A Phase 2, Multi-Center, Open Label Study to Evaluate Efficacy and Safety of Adenoviral p53 (Ad-p53) in Combination With Immune Checkpoint Inhibitor Therapy in Patients With Progression or Recurrence of Head and Neck Squamous Cell Carcinoma (HNSCC) Scientific Title

Purpose
To study the safety and anti-cancer activity of giving the gene therapy Ad-p53 in combination with a PD-1 or PD-L1 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ad-p53, by injection, directly into your tumor</li> <li class="seamTextUnorderedListItem">Doctor's choice of PD-1 inhibitor or PD-L1 inhibitor, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ad-p53 is a type of gene therapy.</li> <li class="seamTextUnorderedListItem">Gene therapy is a treatment that inserts genetic material (DNA or RNA) directly into your cells to prevent or fight disease.</li> <li class="seamTextUnorderedListItem">PD-1 inhibitors are a type of immunotherapy called a checkpoint inhibitor. They get the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). </li> <li class="seamTextUnorderedListItem">PD-L1 inhibitors are also checkpoint inhibitors. They stimulate your immune system to go after cancer cells by blocking a protein called PD-L1 (programmed death-ligand 1).</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced and metastatic cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03544723' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ad5cmv-p53-gene' target='_blank'>NCI Drug Dictionary: Ad-p53</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertodaymag.org/Pages/cancer-talk/First-Immunotherapy-Approved-for-Breast-Cancer.aspx' target='_blank'>Cancer Today: First Immunotherapy Approved for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/PD-1_and_PD-L1_inhibitors' target='_blank'>Wikipedia: PD-1 and PD-L1 inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/gene-therapy' target='_blank'>NCI Dictionary of Cancer Terms: Gene Therapy</a> </li></ul>
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