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NEAREST SITE: 538 miles
Providence Portland Medical Center
Portland,OR

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT02737475

Nivolumab, DPV-001, and Cyclophosphamide Together With or Without the Experimental Immunotherapy BMS-986178

A Phase 1/2a Study of BMS-986178 Administered Alone or in Combination With Nivolumab and/or Ipilimumab in Subjects With Advanced Solid Tumors Scientific Title

Purpose
To study the safety and anti-cancer activity of giving nivolumab (Opdivo®), DPV-001, and cyclophosphamide (Cytoxan®) together with or without the experimental immunotherapy BMS-986178.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received no more than one therapy for advanced or metastatic disease.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986178 </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV</li> <li class="seamTextUnorderedListItem">DPV-001</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV</li> <li class="seamTextUnorderedListItem">DPV-001 </li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i> </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 biopsies</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986178 is an experimental immunotherapy. </li> <li class="seamTextUnorderedListItem">Nivolumab (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). </li> <li class="seamTextUnorderedListItem">It has been approved to treat certain types of cancer but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">DPV-001 is also an experimental immunotherapy </li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) is a chemotherapy routinely used to treat breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02737475' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-ox40-antibody-bms-986178' target='_blank'>NCI Drug Dictionary: BMS 986178</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ubivac.com/pipeline' target='_blank'>UbiVac Drug Information Page: DPV-001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.opdivo.com/?cid=sem_1022882&ovl=isi&gclsrc=aw.ds&' target='_blank'>Bristol Meyers Squibb Drug Information Page: Opdivo® (Nivolumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Cyclophosphamide' target='_blank'>Wikipedia: Cyclophosphamide</a> </li></ul>
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