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1

CF33-hNIS-antiPDL1 Immunotherapy for Metastatic Triple Negative Breast Cancer

A Phase I, First-in-Human Study of Intratumoral Administration of CF33-hNIS-antiPDL1, A Novel Chimeric <span class="highlight">Oncolytic</span> Poxvirus Encoding Human Sodium Iodide Symporter (HNIS) in Patients With Metastatic Triple Negative Breast Cancer

Purpose: To study the safety, side effects, and best dose of CF33-hNIS-antiPDL1, an experimental immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV), triple negative (ER-, PR-, HER2-) breast cancer who have received at least two treatments for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CF33-hNIS-antiPDL1, by injection, every 2 weeks for up to 3 months.</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Oncolytic viruses are a form of immunotherapy that uses viruses to infect and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">CF33-hNIS-antiPDL1 is an <span class="highlight">oncolytic</span> virus.</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/NCT05081492' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearch.org/en-us/immunotherapy/treatment-types/oncolytic-virus-therapy' target='_blank'>Cancer Research Institute.org: Oncolytic Virus Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.valdostadailytimes.com/news/business/city-of-hope-opens-oncolytic-virus-clinical-trial-for-patients-with-advanced-breast-cancer/article_d26fa7ed-8363-5805-a05a-d724a3fe374b.html' target='_blank'>Valdosta Daily Times: City of Hope Opens Oncolytic Virus Clinical Trial for Patients With Advanced Breast Cancer</a> </li></ul>
1

CF33-hNIS-antiPDL1 Immunotherapy for Metastatic Triple Negative Breast Cancer

A Phase I, First-in-Human Study of Intratumoral Administration of CF33-hNIS-antiPDL1, A Novel Chimeric <span class="highlight">Oncolytic</span> Poxvirus Encoding Human Sodium Iodide Symporter (HNIS) in Patients With Metastatic Triple Negative Breast Cancer
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Nearest Location:
353 miles
City of Hope Medical Center
Duarte, CA

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Visits:
1 visit every 2 weeks for up to 3 months

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ClinicalTrials.gov: NCT05081492

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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

Immunotherapies MGA012 and Pelareorep for Advanced Triple Negative Breast Cancer

IRENE Study: Phase 2 Study of INCMGA00012 and the <span class="highlight">Oncolytic</span> Virus Pelareorep in Metastatic Triple Negative Breast Cancer

Purpose: To study the safety and anti-cancer activity of combining the experimental checkpoint inhibitor MGA012 with the <span class="highlight">oncolytic</span> virus pelareorep.

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received one to three prior therapies for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pelareorep, by IV, 2 days a week, every other week, ongoing</li> <li class="seamTextUnorderedListItem">MGA012 (Retifanlimab), by IV, once a month, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MGA012 (Retifanlimab) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking the protein PD-1.</li> <li class="seamTextUnorderedListItem">Pelareorep is an <span class="highlight">oncolytic</span> virus--a 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></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/NCT04445844' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.macrogenics.com/mga012-pd-1/' target='_blank'>Macrogenics Drug Information Page: Retifanlimab (MGA012)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-pd-1-monoclonal-antibody-mga012' target='_blank'>NCI Drug Dictionary: MGA012</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Pelareorep' target='_blank'>Wikipedia: Pelareorep</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancer-news.com/2020/09/14/first-patient-dosed-irene-clinical-trial-testing-immunotherapy-oncolytic-virus-combo-for-tnbc/' target='_blank'>Breast Cancer News: First Patient Dosed in IRENE Trial Testing Immunotherapy-Oncolytic Virus Combo</a> </li><li class='seamTextUnorderedListItem'><a href='https://graspcancer.org/wp-content/uploads/2021/12/Group6E_2.pdf' target='_blank'>GRASP: IRENE Study research poster</a> </li></ul>
3

Immunotherapies MGA012 and Pelareorep for Advanced Triple Negative Breast Cancer

IRENE Study: Phase 2 Study of INCMGA00012 and the <span class="highlight">Oncolytic</span> Virus Pelareorep in Metastatic Triple Negative Breast Cancer
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Nearest Location:
2107 miles
The Ohio State University Stefanie Spielman Comprehensive Breast Center
Columbus, OH

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Visits:
5 visits per month, ongoing

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ClinicalTrials.gov: NCT04445844

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Phase II

4

PVSRIPO Vaccine in Stage II, III and IV Triple Negative Breast Cancer

Examining <span class="highlight">Oncolytic</span> Poliovirus Bioactivity in Tumor Tissue After Intratumoral Administration of PVSRIPO in Women With Triple Negative Breast Cancer

Purpose: To look at the safety, effects (good and bad) and best dose of an experimental immunotherapy called PVSRIPO.

Who is this for?: Women with stage II-III triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options or who has metastatic (stage IV) TNBC with a local recurrence on the chest wall. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PVSRIPO, by injection, one time </li> <li class="seamTextUnorderedListItem">Surgery as planned</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PVSRIPO is a vaccine made out of a modified poliovirus. </li> <li class="seamTextUnorderedListItem">The vaccine uses the virus to get the immune system to kill cancer cells. </li> <li class="seamTextUnorderedListItem">You can not get polio from the vaccine.</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/NCT03564782' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/recombinant-oncolytic-poliovirus-pvs-ripo' target='_blank'>Cancer.gov: Recombinant oncolytic poliovirus PVS-RIPO</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.istarioncology.com/our-science/pvs-ripo/' target='_blank'>Sponsor site: PVSRIPO</a> </li><li class='seamTextUnorderedListItem'><a href='http://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.e12641' target='_blank'>Journal of Clinical Oncology: Recombinant oncolytic poliovirus combined with checkpoint blockade for breast cancer therapy</a> </li></ul>
4

PVSRIPO Vaccine in Stage II, III and IV Triple Negative Breast Cancer

Examining <span class="highlight">Oncolytic</span> Poliovirus Bioactivity in Tumor Tissue After Intratumoral Administration of PVSRIPO in Women With Triple Negative Breast Cancer
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Nearest Location:
2385 miles
Duke University Medical Center
Durham, NC

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Visits:
1 visit

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ClinicalTrials.gov: NCT03564782

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Phase NA

5

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>
5

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