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1

<span class="highlight">Oncolytic</span> Virus Alone or With Pembrolizumab for People with Advanced Breast Cancer

A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Metastatic or Advanced Solid Tumors (MAST).(VAXINIA)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of CF33-hNIS, an experimental <span class="highlight">oncolytic</span> virus, alone or with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received at least 2 lines of therapy for advanced disease. View full eligibility criteria

What's involved?

<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">CF33-hNIS, by injection or IV, 2 times in 3 weeks, then every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CF33-hNIS, by injection or IV, 2 times in 3 weeks, then every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CF33-hNIS is an experimental immunotherapy called an <span class="highlight">oncolytic</span> virus. <span class="highlight">Oncolytic</span> viruses are a form of immunotherapy that uses viruses to infect and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05346484' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.imugene.com/oncolytic-virus' target='_blank'>Imugene: CF33-hNIS Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearch.org/treatment-types/oncolytic-virus-therapy' target='_blank'>Cancer Research Institute: Oncolytic Viruses</a> </li></ul>
1

<span class="highlight">Oncolytic</span> Virus Alone or With Pembrolizumab for People with Advanced Breast Cancer

A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Metastatic or Advanced Solid Tumors (MAST).(VAXINIA)
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Nearest Location:
353 miles
City of Hope Medical Center
Duarte, CA

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT05346484

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Phase I

2

CAR-T Cell Immunotherapy & Immunotherapy Injected Directly into Tumors for Metastatic HER2 Positive Breast Cancer

A First in Human Phase I Trial of Binary <span class="highlight">Oncolytic</span> Adenovirus in Combination With HER2-Specific Autologous CAR T Cells in Patients With Advanced HER2 Positive Solid Tumors

Purpose: To study the safety, anti-cancer activity and other effects (good and bad) of giving a HER2-specific CAR-T Cell immunotherapy and an immunotherapy injected directly into a tumor.

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAdVEC, by injection directly into a tumor, one time</li> </ul> <p class="seamTextPara"> followed by </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2-specific CAR-T Cell therapy, by IV, one time</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule. Hospital stay may be required.</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR-T is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The cells are removed from your blood, modified with chimeric antigen receptors (CARs) that allow them to attack proteins on cancer cells, and then put back in your body.</li> <li class="seamTextUnorderedListItem">CAdVEC is an <span class="highlight">oncolytic</span> adenovirus--this means it targets and kills cancer cells. It may directly kill cancer cells and stimulate your immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">CAdVEC is injected directly into a tumor. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of HER2 positive cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03740256' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://ncit.nci.nih.gov/ncitbrowser/pages/concept_details.jsf?dictionary=NCI_Thesaurus&version=20.07d&code=C158743&ns=ncit&type=all&key=null&b=1&n=0&vse=null' target='_blank'>NCI Thesaurus: CAdVEC</a> </li></ul>
2

CAR-T Cell Immunotherapy & Immunotherapy Injected Directly into Tumors for Metastatic HER2 Positive Breast Cancer

A First in Human Phase I Trial of Binary <span class="highlight">Oncolytic</span> Adenovirus in Combination With HER2-Specific Autologous CAR T Cells in Patients With Advanced HER2 Positive Solid Tumors
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Nearest Location:
1643 miles
Baylor St. Luke's Medical Center
Houston, TX

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Visits:
May require hospital stay

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ClinicalTrials.gov: NCT03740256

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Phase I

3

MEM-288 Vaccine for Advanced Triple Negative Breast Cancer

Phase I Study of MEM-288 <span class="highlight">Oncolytic</span> Virus in Solid Tumors Including Non-Small Cell Lung Cancer (NSCLC)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of MEM-288, an experimental vaccine.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that has progressed after treatment with chemotherapy and at least 1 PD-1/PD-L1 inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEM-288 vaccine, by injection, every 3 weeks, 2-6 sessions over 2-4 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires at least 1 biopsy</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEM-288 is a vaccine that contains an <span class="highlight">oncolytic</span> virus, a type of virus that targets and kills cancer cells. It may directly kill cancer cells and stimulate your immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">MEM-288 is injected directly into your tumor.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05076760' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.memgenbio.com/' target='_blank'>Memgen Drug Information Page: MEM-288</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dukehealth.org/clinical-trials/directory/pro00109517' target='_blank'>Duke Health Clinical Trial Information Page: MEM-288</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/breast-cancer-vaccine-explainer/?utm_source=google&utm_medium=cpc&gclid=CjwKCAjwy_aUBhACEiwA2IHHQEa-vmAWsJZO8726oOg7bjIG8ru8smOjq4_rDRC9cRbLdE3XRu6cVRoCwCEQAvD_BwE' target='_blank'>Breast Cancer Research Foundation: Breast Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearch.org/en-us/immunotherapy/treatment-types/oncolytic-virus-therapy' target='_blank'>Cancer Research Institute: Oncolytic Viruses</a> </li></ul>
3

MEM-288 Vaccine for Advanced Triple Negative Breast Cancer

Phase I Study of MEM-288 <span class="highlight">Oncolytic</span> Virus in Solid Tumors Including Non-Small Cell Lung Cancer (NSCLC)
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Nearest Location:
2385 miles
Duke Cancer Institute
Durham, NC

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Visits:
1 visit every 3 weeks for 2-4 months

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ClinicalTrials.gov: NCT05076760

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Phase I

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