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Vaccines and Immunotherapy

The Immunotherapy Opdivo & Abraxane for Recurrent HER2-Negative Metastatic Breast Cancer

A Phase 1, Open-Label, Multicenter, Safety Study of Nivolumab (BMS-936558) in Combination With Nab-Paclitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, Nab-Paclitaxel / Carboplatin in Stage IIIB/IV Non-Small Cell Lung Cancer or Nab-Paclitaxel in Recurrent Metastatic Breast Cancer (NCT02309177)

Summary

Researchers are trying to find more effective treatments for metastatic breast cancer. nab-Paclitaxel (Abraxane®) is a chemotherapy drug approved in the treatment of breast cancer that has spread after treatment with combination chemotherapy or that has come back within 6 months after chemotherapy treatment post-surgery. Nivolumab (Opdivo®) is an immunotherapy approved in the treatment of certain types of metastatic melanoma and non-small cell lung cancer. Nivolumab (Opdivo®) blocks a protein called PD-1 (programmed cell death 1). Blocking PD-1 prevents a known pathway found in certain tumors and may allow the body’s own immune cells to attack tumors. This study is primarily evaluating the safety of combining Opdivo with two different regimens of Abraxane in patients with HER2-negative, recurrent metastatic breast cancer. Anti-tumor activity of Opdivo in combination with these two Abraxane regimens will be preliminarily assessed. (This study also is enrolling patients with pancreatic and non-small cell lung cancer).
This is a Phase I trial

Halaven & Keytruda for Metastatic Triple-Negative Breast Cancer

An Open-Label, Single-Arm Multicenter Phase 1b/2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Combination With Pembrolizumab in Subjects With Metastatic Triple-Negative Breast Cancer (mTNBC) (NCT02513472)

Summary

Eribulin mesylate (Halaven®) is a chemotherapy drug used to treat metastatic breast cancer that is not responding to other chemotherapy drugs. Pembrolizumab (Keytruda®) is an immunotherapy drug that blocks a programmed cell death (PD-1) protein that keeps the immune system from going after cancer cells. This study is investigating the safety and effectiveness of giving Halaven and Keytruda to patients with metastatic triple-negative breast cancer who have received no more than two prior chemotherapies for metastatic disease.
This is a Phase I-II trial

MEDI4736 and Chemotherapy Before Surgery for Stage I-III Triple Negative Breast Cancer

Single Arm Neoadjuvant Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) Concomitant With Weekly Nab-paclitaxel and Dose-dense Doxorubicin/Cyclophosphamide (ddAC) Chemotherapy for Clinical Stage I-III Triple Negative Breast Cancer (NCT02489448)

Summary

MEDI4736 is a new immunotherapy drug. By blocking a protein called PD-1 (programmed cell death 1), it allows the immune system to go after cancer cells. Doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®)--known as AC chemotherapy--and nab-paclitaxel (Abraxane®) are routinely used to treat breast cancer. Giving MEDI4736 with this chemotherapy regimen before surgery (called neoadjuvant therapy) may make the chemotherapy more effective. This study will investigate the best dose and effectiveness of MEDI4736 for use with this chemotherapy regimen when it is given before surgery to individuals with stage I-III triple negative breast cancer.
This is a Phase I-II trial

Immunotherapy and Chemotherapy for Metastatic Breast (and Other) Cancer

Phase IB Study Investigating the Tolerability, Immunomodulatory Impacts and Therapeutic Correlates of the Novel Toll-like Receptor 8 Agonist Motolimod (MOTO) Plus Cyclophosphamide (CTX) Treatment of Advanced Solid Tumors (NCT02650635)

Summary

VTX-2337 is a new type of immunotherapy drug called a toll-like receptor-8 (TLR-8) agonist. It stimulates the body's immune system to go after cancer cells. Cyclophosphamide (Cytoxan®) is a chemotherapy drug commonly used to treat breast (and other) cancers. Laboratory and early studies suggest combining VTX-2337 with Cytoxan may be an effective treatment combination. Pegfilgrastim (Neulasta®) is given along with chemotherapy to reduce the patient's risk of developing an infection. This study is evaluating the safety and effectiveness of using VTX-2337 and Cytoxan to treat metastatic breast cancer and other solid tumors.
This is a Phase I trial

Keytruda + Chemo or an Aromatase Inhibitor for HER2-Negative Metastatic Breast Cancer

MK-3475 (Pembrolizumab) in Combination With an Anthracycline or Anti-estrogen Therapy in Patients With Triple Negative and Hormone Receptor Positive (HR+ HER2-) Metastatic Breast Cancer (NCT02648477)

Summary

Pembrolizumab (Keytruda®) is an immunotherapy drug that targets the programmed cell death (PD-1) protein. Blocking this protein allows the body's immune system to attack cancer cells. Doxorubicin (Adriamycin®) is a chemotherapy drug commonly used to treat breast cancer. Aromatase inhibitors (anastrozole/Arimidex®, letrozole/Femara®, exemestane/Aromasin®) are used to treat hormone-sensitive tumors in postmenopausal women. This study is investigating the safety and effectiveness of using Keytruda to treat HER2-negative metastatic breast cancer. In this study, patients with triple-negative tumors will receive Adriamycin along with Keytruda, while patients with hormone-sensitive tumors will receive an AI along with Keytruda.To be eligible, participants must not have been treated previously with Keytruda.
This is a Phase II trial

A Vaccine & Chemotherapy Followed by Anakinra or Booster Shots for Triple Negative Tumors

Pilot Safety Trial of Anakinra Combined With Chemotherapy and Dendritic Cell Vaccine in Patients With Locally Advanced, Triple-Negative Breast Cancer (NCT02018458)

Summary

Immunotherapy–teaching the body's immune system to go after cancer cells—is a new area of cancer research. A dendritic cell vaccine is a patient-specific vaccine that is manufactured by taking a blood sample from the patient. After receiving the vaccine, patients typically receive a series of booster shots. Anakinra (kineret) stops inflammation by blocking IL-1 β, an immune protein found in high levels in breast cancer. It is currently used to treat rheumatoid arthritis and other autoimmune diseases. Studies suggest it may help bolster cancer vaccines. ACT (Adriamycin®, Cytoxan®, Taxol®) is a chemotherapy regimen commonly used to treat breast cancer. This study is comparing the effectiveness of using vaccine booster shots or Anakinra following treatment with ACT and the dendritic cell vaccine in patients with locally advanced triple negative breast cancer.
This is a Phase I-II trial

Immunotherapy and Abraxane for Advanced Triple Negative Breast Cancer

A Study of MPDL3280A in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple Negative Breast Cancer (NCT02425891)

Summary

Researchers are investigating the effectiveness of immunotherapies in patients with triple negative (ER-, PR- and HER2-) breast cancer. MPDL3280a (atezolizumab) is an investigational immunotherapy that stimulates the body's immune system to go after cancer cells. It works by blocking a protein called programmed cell death ligand-1 (PD-L1) that normally keeps the body's immune system from attacking and destroying tumor cells. Nab-paclitaxel (Abraxane®) is a chemotherapy drug routinely used to treat advanced breast cancer. This study is comparing the safety and effectiveness of Abraxane and atezolizumab to Abraxane and a placebo in patients with previously untreated locally advanced or metastatic triple negative breast cancer.
This is a Phase III trial

A Vaccine + Chemotherapy to Prevent Recurrence in Triple-Negative Breast Cancer

A Randomized Multicenter Phase II Trial to Evaluate the Safety and Immunogenicity of Two Doses of Vaccination With Folate Receptor Alpha Peptides With GM-CSF in Patients With Triple Negative Breast Cancer (NCT02593227)

Summary

Researchers think that immunotherapy treatments used after completing standard therapy may help prevent breast cancer from coming back. Folate Receptor-alpha (FR-alpha) vaccine is a new type of immunotherapy that stimulates the immune system. Laboratory studies suggest it may be able to help prevent a breast cancer recurrence. FR-alpha is a receptor found in 86% of triple-negative breast cancer cells. GM-CSF is a substance added to the vaccine to improve the immune response. Cyclophosphamide (Cytoxan®) is a chemotherapy drug routinely used to treat breast cancer. This study is comparing the effectiveness of two different doses of the FR-alpha vaccine when it is given with or without Cytoxan to women who have completed neoadjuvant (before surgery) or adjuvant (after surgery) treatment for stage IIb-III triple-negative breast cancer.
This is a Phase II trial

Keytruda and Abraxane in HER2-Negative Metastatic Breast Cancer

Phase II Study of Pembrolizumab and Nab-paclitaxel in HER-2 Negative Metastatic Breast Cancer (NCT02752685)

Summary

Researchers are trying to see which treatment combinations are best for HER2-negative breast cancer. This study is looking at the safety and effectiveness of using a chemotherapy drug along with an immunotherapy drug. The chemotherapy drug is nab-paclitaxel (Abraxane®), which is used to treat advanced breast cancer. The immunotherapy drug is pembrolizumab (Keytruda®), which gets the immune system to go after cancer cells. To take part in this study, you must have metastatic breast cancer that is HER2-negative.
This is a Phase II trial

A Vaccine to Treat HER2+ Advanced Breast Cancer

A Phase I Study of an Adenoviral Transduced Autologous Dendritic Cell Vaccine Expressing Human HER2/Neu ECTM in Adults With Tumors With 1-3+ HER2/Neu Expression (NCT01730118)

Summary

Researchers are trying to develop new ways treat HER2+ metastatic breast cancer. One approach being studied is a vaccine that would teach the immune system to recognize and kill HER2+ cancer cells. The vaccine that is being used in this study is called AdHER2/neu dendritic cell vaccine. It is custom-made for each patient. This means that each patient's immune cells are collected and then used to produce a vaccine that is just for them. This vaccine is being studied in HER2+ breast cancer as well as other types of HER2+ solid tumors. (Ovarian, colon, non-small cell lung, renal cell, bladder and prostate cancer can also be HER2+.)
This is a Phase I trial

Keytruda® for Metastatic Triple Negative Breast Cancer

A Phase II Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy for Metastatic Triple-Negative Breast Cancer (mTNBC) - (KEYNOTE-086) (NCT02447003)

Summary

Researchers are studying new ways to treat triple-negative breast cancer. Pembrolizumab (Keytruda®) is an immunotherapy. It works by disabling a programmed cell death (PD-1) protein that normally keeps the body's immune system from attacking and destroying tumor cells. Keytruda is approved for treating metastatic melanoma. This trial is investigating the safety and effectiveness of using Keytruda to treat metastatic triple-negative breast cancer.
This is a Phase II trial

A Vaccine for Treating HER2-Negative Advanced Breast Cancer

A Phase I Trial of the Safety and Immunogenicity of a Multiple Antigen Vaccine (STEMVAC) in HER2 Negative Advanced Stage Breast Cancer Patients (NCT02157051)

Summary

Vaccines made from DNA from tumor cells may help the body build an effective immune response to the cancer. This study is looking at how cancer cells respond to a new vaccine called STEMVAC that is designed to target a protein on breast cancer stem cells that is resistant to chemotherapy. In this trial, researchers are studying the side effects and best dose of this vaccine for treating HER2-negative, advanced (stage III and IV) breast cancer.
This is a Phase I trial

Keytruda for Metastatic Inflammatory Breast Cancer

A Phase II Study of Anti-PD-1 (MK-3475) Therapy in Patients With Metastatic Inflammatory Breast Cancer Who Have Received Prior Chemotherapy With Clinical Response (NCT02411656)

Summary

Pembrolizumab (Keytruda®) is an immunotherapy that helps the body's immune system slow or stop cancer cell growth by blocking a protein known as programmed cell death receptor (PD-1). It is approved for treating metastatic melanoma. Early studies suggest Keytruda may also be effective for treating metastatic inflammatory breast cancer. This study is looking at the safety and effectiveness of using Keytruda to treat patients with metastatic inflammatory breast cancer.
This is a Phase II trial

PLX3397 and Keytruda in Metastatic Triple Negative Breast Cancer

Phase 1/2a Study of Double-Immune Suppression Blockade By Combining a CSF1R Inhibitor (PLX3397) With An Anti-PD-1 Antibody (Pembrolizumab) To Treat Advanced Melanoma And Other Solid Tumors (NCT02452424)

Summary

PLX3397 targets the receptor for CSF1 (Colony Stimulating Factor 1), an essential growth factor for cancer cells. Pembrolizumab (Keytruda®) is an immunotherapy. It blocks a programmed cell death (PD-1) protein that keeps the immune system from going after cancer cells. Keytruda is approved for treating metastatic melanoma and lung cancer. This study is investigating the best dose, safety and effect of combining PLX3397 and Keytruda in patients with metastatic triple negative breast cancer. This study also is enrolling patients with other types of cancer.
This is a Phase I-II trial

A Vaccine for Women with Triple-Negative Tumors Treated with Chemo Before Surgery

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Personalized Polyepitope DNA Vaccine Strategy in Breast Cancer Patients With Persistent Triple-Negative Disease Following Neoadjuvant Chemotherapy (NCT02348320)

Summary

This study is investigating the safety and efficacy of a personalized Polyepitope DNA vaccine. A "personalized" vaccine is produced, in part, from a patient's own cancer cells. This increases the chance the vaccine will successfully stimulate the immune system to go after cancer cells. To be eligible, participants must have received chemotherapy prior to having surgery (called neoadjuvant chemotherapy) and still have some portion of the tumor remaining in the breast.
This is a Phase I trial

Reversing Hormone Therapy Resistance in Metastatic Breast Cancer

Reversing Hormone Therapy Resistance With Epigenetic-immune Modification: Phase II Trial of Vorinostat, Tamoxifen and Pembrolizumab in Hormone Receptor Expressing Advanced Breast Cancer (NCT02395627)

Summary

This trial is looking at the best time to introduce the immunotherapy drug pembrolizumab (Keytruda®)—cycle 2 or cycle 4—to stage IV breast cancer patients started on a regimen of tamoxifen and vorinostat (Zolinza®). Keytruda is an immunotherapy drug that blocks a protein that keeps the immune system from going after cancer cells. It is approved for treating melanoma and non-small-cell lung cancer. Zolinza works by inhibiting a protein called histone deacetylase (HDAC). It is used to treat a type of lymphoma. Tamoxifen is an anti-estrogen therapy routinely used to treat early-stage and metastatic breast cancer. All participants will receive all three therapies. This is the first study to look at whether an immunotherapy can reduce hormone resistance in metastatic breast cancer. It is also the first study to look at the combination of Zolinza, tamoxifen and Keytruda in patients with ER+ advanced breast cancer who have already tried other hormone therapies.
This is a Phase II trial

Breast Cancer Vaccine for Triple-Negative Breast Cancer Following Chemo Before Surgery

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy (NCT02427581)

Summary

A peptide is a naturally occurring biological molecule made up of amino acids. Researchers have developed a way to create a personalized synthetic long peptide vaccine that can generate an immune response to breast cancer cells by targeting mutations specific to a person's tumor. This study is investigating the side effects and best dose of this vaccine in patients with stage II-III triple-negative breast cancer who received chemotherapy before surgery and still have signs of the tumor in their breast.
This is a Phase I trial

A New Imumunotherapy Drug (PDR001) For Advanced Triple Negative Breast Cancer

Open Label Multicenter Phase I/II Study of the Safety and Efficacy of PDR001 Administered to Patients With Advanced Malignancies (NCT02404441)

Summary

PDR001 blocks a protein called PD-1 (programmed cell death 1). Blocking PD-1 allows the body’s own immune cells to attack cancer cells.The purpose of this "first-in-human" study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of PDR001, a new type of PD-1 inhibitor. To be eligible, participants must have triple negative breast cancer that has progressed following their last treatment.
This is a Phase I-II trial

Vaccine for Metastatic Breast Cancer

A Phase I Vaccine Study With Autologous Dendritic Cells Loaded With Oncofetal Antigen/iLRP in Patients With Metastatic Breast Cancer (NCT00715832)

Summary

Vaccines may enable the body to build an immune response to kill tumor cells. This study is investigating a vaccine that uses a molecule called "oncofetal antigen" or OFA that is found only on cancer cells. Because OFA is unique to cancer, the investigators believe it could be used to teach the immune system to kill cancer cells. The purpose of this study is to evaluate the vaccine's safety and to identify what, if any, side effects it causes. The investigators also want to see if the vaccine will get the immune system to build an immune response to cancer cells and stop the cancer from growing.
This is a Phase I trial

Keytruda Compared to Chemotherapy for Metastatic Triple-Negative Breast Cancer

A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab Versus Single Agent Chemotherapy Per Physician's Choice for Metastatic Triple Negative Breast Cancer (mTNBC) - (KEYNOTE-119) (NCT02555657)

Summary

Pembrolizumab (Keytruda) is an immunotherapy drug that blocks PD-1, a protein that normally keeps the immune system from destroying cancer cells. Previous studies have found Keytruda is effective in triple negative breast cancer. This study is comparing the effectiveness of Keytruda to physician's choice standard of care chemotherapy—capecitabine (Xeloda®), eribulin (Halaven), gemcitabine (Gemzar) or vinorelbine (Navelbine®)—in patients with metastatic triple negative breast cancer.
This is a Phase III trial

Entinostat, Opdivo and Yervoy in Advanced HER2-Negative Breast Cancer

A Phase 1 Study Evaluating Safety, Tolerability, and Preliminary Antitumor Activity of Entinostat and Nivolumab With or Without Ipilimumab in Advanced Solid Tumors (NCT02453620)

Summary

Entinostat is a histone deacetylase (HDAC) inhibitor. It is designed to block HDAC enzymes, which are needed for cell growth. Nivolumab (Opdivo®) is an immunotherapy that blocks a protein called PD-1 (programmed cell death 1). Blocking PD-1 may allow the body’s own immune cells to attack cancer cells. It is approved for advanced lung cancer. Ipilimumab (Yervoy®) is an immunotherapy that stimulates T-cells in the body’s immune system. It is approved for treating patients with advanced melanoma. This trial is designed to identify the side effects and best dose of entinostat and Opdivo when the two drugs are given with Yervoy to treat advanced HER2-negative breast cancer.
This is a Phase I trial

Tremelimumab for Advanced Triple-Negative Breast Cancer (and Other Solid Tumors)

A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients With Advanced Solid Tumors (NCT02527434)

Summary

Tremelimumab is a new anti-cancer therapy that blocks the production of a protein called CTLA-4 that keeps the immune system from attacking cancer cells. MEDI4736 is an immunotherapy that blocks PD-1 (programmed cell death-1) protein. Blocking this protein stimulates the immune system to go after cancer cells. This study is comparing the safety and efficacy of using tremelimumab to treat advanced triple-negative breast cancer (and other solid tumors). Patients whose cancer progresses on tremelimumab may have the option of going on to receive MEDI4736 alone or MEDI4736 in combination with tremelimumab.
This is a Phase II trial

Atezolizumab & Kadcyla or Atezolizumab, Herceptin & Perjeta in HER2-Positive Breast Cancer

A Phase Ib, Open-Label, Two-Arm Study Evaluating The Safety And Pharmacokinetics of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Trastuzumab Emtansine or With Trastuzumab And Pertuzumab in Patients With Her2 Positive Breast Cancer (NCT02605915)

Summary

Atezolizumab (MPDL3280A) is a new immunotherapy drug that blocks the programmed death 1 (PD-1) protein. Blocking the protein allows the immune system to kill cancer cells. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are HER2-targeted therapies. Trastuzumab emtansine (Kadcyla®) combines the chemotherapy drug DM1 with Herceptin. This study is comparing the safety and effectiveness of atezolizumab, Herceptin and Perjeta to atezolizumab and Kadcyla in patients with HER2-positive metastatic breast cancer or with a HER2-positive primary tumor >2.0cm.
This is a Phase I trial

Immunotherapy for Metastatic Breast (and Other Solid) Tumors

A Phase 1 Study to Evaluate the Safety and Tolerability of Anti-PD-L1, MEDI4736, in Combination With Tremelimumab in Subjects With Advanced Solid Tumors (NCT01975831)

Summary

MEDI4736 and tremelimumab are immunotherapy drugs. They block proteins that keep the immune system from going after cancer cells. MEDI4736 blocks the PD-1 (programmed cell death-1) protein. Tremelimumab blocks the CTLA-4 protein. This study is investigating the safety and efficacy of using MEDI4736 and tremelimumab to treat metastatic breast (and other solid) tumors.
This is a Phase I trial

A Tumor Associated Antigen Vaccine for Advanced Breast and Other Cancers

Tumor Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes Administered to Patients With Solid Tumors (NCT02239861)

Summary

Tumor-associated antigens (TAAs) are proteins that are specific to cancer cells. They are typically not found, or found only in small numbers, on normal human cells.This study is investigating the safety and effectiveness of a vaccine that uses tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes to kill cancer cells. The vaccine targets five common TAAs: NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. During the study, patients will have blood tests to to determine what level, if any, of tumor-associated antigens are present in their blood.
This is a Phase I trial

Hypofractionated Radiation Therapy with MEDI4736 & Tremelimumab for Metastatic Cancer

Phase I Trial Of Hypofractionated Radiotherapy In Combination With MEDI4736 And Tremelimumab For Patients With Metastatic Melanoma And Lung, Breast And Pancreatic Cancers (NCT02639026)

Summary

Hypofractionated radiation therapy involves giving larger doses of radiation in fewer sessions over a shorter period of time. MEDI4736 and tremelimumab are two different types of immunotherapy drugs. MEDI4736 blocks the PD-1 (programmed cell death-1) protein. Blocking this protein makes it possible for the immune system to go after cancer cells. Tremelimumab blocks the CTLA-4 protein, which also keeps the immune system from attacking cancer cells. This study is comparing the safety and the effectiveness of two different hypofractionated radiation therapy schedules when used along with MEDI4736 and tremelimumab to treat metastatic breast (and other) tumors.
This is a Phase I trial

Combination Immunotherapy in HER2-Negative Metastatic Breast Cancer

A Single Arm Phase II Study Evaluating the Efficacy and Safety of MEDI4736 in Combination With Tremelimumab in Patients With Metastatic Her2 Negative Breast Cancer (NCT02536794)

Summary

MEDI4736 and tremelimumab are two new immunotherapy drugs currently being studied in clinical trials. The drugs work in different ways. MEDI4736 targets the programmed cell death 1 (PD-1)/B7H1 protein. Tremelimumab targets the CTLA4 protein. Combining two immunotherapy drugs that work in different ways may be more effective than using one alone. This study is evaluating the safety and efficacy of MEDI4736 and tremelimumab in women with HER2-negative metastatic breast cancer.
This is a Phase II trial

A Breast Cancer Vaccine & Chemo Before Surgery in Stage I-III Breast Cancer

A Combined Phase I/II Feasibility-and-Efficacy Study of a Carbohydrate Mimotope-based Vaccine With MONTANIDE™ ISA 51 VG Combined With Neoadjuvant Chemotherapy (NCT02229084)

Summary

Cancer researchers are studying many different types of cancer vaccines. P10s-PADRE is a new vaccine that is designed to get the immune response to fight breast cancer. Montande™ ISA 51 VG is an oil-based substance that help enhance the immune response triggered by P10s-PADRE vaccine. Giving a therapy before surgery—called neoadjuvant treatment—allows researchers to see if the treatment can shrink the tumor. This study is looking at the effect that the P10s-PADRE vaccine (used with Montande) has when it is given along with neoadjuvant chemotherapy to patients with estrogen receptor positive (ER+) stage I, II or III breast cancer.
This is a Phase I-II trial

AM0010 Alone or With Chemo or Immunotherapy for Advanced Breast (and other Solid) Tumors

A Phase 1, Open-Label Dose Escalation First-in-Human Study to Evaluate the Tolerability, Safety, Maximum Tolerated Dose, Preliminary Clinical Activity and Pharmacokinetics of AM0010 in Patients With Advanced Solid Tumors (NCT02009449)

Summary

AM0010 is a new immunotherapy drug--a pegylated recombiant human IL-10--that activates a type of white blood cell called T-cells, to fight cancer cells. Laboratory studies suggest AM0010 may be effective in treating advanced solid tumors. This first-in-human study is evaluating the safety, best dose and tolerability of AM0010 when it is given alone or in combination with chemotherapy or immunotherapy to treat advanced triple negative breast (and other solid) tumors.
This is a Phase I trial

Selumetinib and MEDI4736 for Advanced Breast (and Other) Solid Tumors

A Phase I, Open-Label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of Selumetinib (AZD6244 Hyd-sulfate) in Combination With MEDI4736 in Patients With Advanced Solid Tumours (NCT02586987)

Summary

Selumetinib (AZD6244 Hyd-sulfate) is a new type of targeted therapy called an MEK inhibitor. MEDI4736 is an investigational immunotherapy. It blocks PD-1, which stimulates the immune system to go after cancer cells. This study is investigating the safety, best dose, and activity of selumetinib when it is given with MEDI4736 to treat advanced breast (and other solid) tumors. To be eligible, participants must have not yet received any type of immunotherapy.
This is a Phase I trial

Keytruda with INCB039110 or INBC050465 for Advanced Breast (and Other Solid) Tumors

A Platform Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Pembrolizumab + INCB Combinations in Advanced Solid Tumors (NCT02646748)

Summary

Pembrolizumab (Keytruda®) targets a protein called programmed cell death-1 (PD-1). Blocking this protein gets the immune system to kill cancer cells. NCB039110 and INCB050465 are two new experimental targeted therapies. INCB039110 works by inhibiting the JAK pathway. INCB050465 works by inhibiting the PI3K pathway. There are two parts to this study. In the first part, the researchers will determine the best dose of INCB039110 or INCB050465 to use with Keytruda. In the second part, the researchers will use the best dose of INCB039110 or INCB050465 along with Keytruda to test its safety and effectiveness in patients with advanced breast cancer. To be eligible for the second part of the study, patients must have progressed on or not previously been treated with a PD-1 pathway targeted therapy. This study also is enrolling patients with other types of solid tumors.
This is a Phase I trial

Targeted Radiation & an Immunotherapy (MEDI6469) for Breast Cancer in the Lung or Liver

Phase I/II Study of Stereotactic Body Radiation Therapy to Metastatic Lesions in the Liver or Lung in Combination With Monoclonal Antibody to OX40 (MEDI6469) in Patients With Progressive Metastatic Breast Cancer After Systemic Therapy. (NCT01862900)

Summary

Researchers are studying the safety and effectiveness of using the immunotherapy drug MEDI6469 along with targeted radiation to treat metastatic breast cancer. To take part, you must have metastatic breast cancer that has spread to the liver or lung and can be treated with radiation. You must also have previously received chemotherapy or hormone therapy.

Stereotactic body radiation therapy (SBRT) is a technique that uses high-dose, focused radiation to treat small, isolated tumors. It can be used for breast cancer that has spread to the lung or the liver. MEDI6469 is an immunotherapy that turns on the OX40 protein. Turning on this protein gets the immune system to go after cancer cells.
This is a Phase I-II trial

Study of MGD009 in Metastatic Breast (and other) Tumors With B7-H3

Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD009, A Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART) Protein in Patients With Unresectable or Metastatic B7-H3-Expressing Neoplasms (NCT02628535)

Summary

Scientists have found that many cancer cells have high levels of a protein called B7-H3. Blocking this protein may be an effective way to treat cancer. MGD009 is a new drug that recognizes B7-H3 on cancer cells. It works by getting immune cells to go after B7-H3-expressing cancer cells. This study is evaluating the safety, tolerability, and best dose of MGD009 for treating metastatic breast (and other) cancers that test positive for B7-H3. Patients will have their tumor tested for the B7-H3 protein. Those whose tumors test positive will be eligible for the study.
This is a Phase I trial

Ad-RTS-hIL-12 Immunotherapy For Advanced Breast Cancer

A Single-arm, Open-label Study of Ad-RTS-hIL-12 + Veledimex Following First- or Second-Line Standard Treatment in Subjects With Locally Advanced or Metastatic Breast Cancer (NCT02423902)

Summary

This study is assessing the safety of a new type of immunotherapy drug in women who have already responded to one or two regimens of chemotherapy for locally advanced or metastatic breast cancer. The treatment consists of a genetically modified virus called Ad-RTS-hIL-12 that is given in combination with a drug called veledimex. Together, Ad-RTS-hIL-12 and veledimex are designed to increase production of a protein called IL-12, which may strengthen the ability of the immune system to fight cancer cells and also decrease blood flow to tumors. Ad-RTS-hIL-12 is injected directly into the tumor once (after the patient has received local or general anesthesia). It is activated by veledimex, a pill which is taken daily for seven days after the injection. To be eligible for this study, a patient must have at least two measurable cancer lesions.
This is a Phase I-II trial

Niraparib and Pembrolizumab for Advanced Triple-Negative Breast (or Ovarian) Cancer

Phase 1/2 Clinical Study of Niraparib in Combination With Pembrolizumab in Patients With Advanced or Metastatic Triple-Negative Breast Cancer and in Patients With Recurrent Ovarian Cancer (NCT02657889)

Summary

Niraparib (formally MK-4827) is a PARP-inhibitor. PARP inhibitors kill cancer cells by preventing the PARP enzyme from repairing damaged DNA. Pembrolizumab (KEYNOTE) is an immunotherapy drug that blocks a PD-1 (programmed cell death) protein. By blocking this protein, the immune system is able to identify and kill cancer cells. Laboratory studies suggest using niraprarib along with pembrolizumab could be an effective breast cancer treatment. This study is investigating the safety and efficacy of using niraparib and pembrolizumab to treat advanced triple-negative breast cancer. Patients must not have been treated previously with an anti-PD-1, PD-L1, anti-PD-L2 or PARP inhibitor. This study is also recruiting women with advanced ovarian cancer.
This is a Phase I-II trial

Keytruda® with Chemotherapy for Advanced Breast (and Other) Cancer

A Phase Ib/II Study of Pembrolizumab Plus Chemotherapy in Patients With Advanced Cancer (PembroPlus) (NCT02331251)

Summary

The PembroPlus clinical trial is an immunotherapy study for patients with different types of stage III or stage IV cancer. Pembrolizmab (Keytruda®) is an immunotherapy that blocks PD-1, a protein that normally keeps the immune system from destroying cancer cells. Keytruda is approved for treating metastatic melanoma. This study is investigating the effect of adding Keytruda to conventional chemotherapy in patients with advanced triple-negative or ER+ breast (and other) cancers.
This is a Phase I-II trial

Immunotherapies for Metastatic Breast (and Other) Cancer

An Open-Label Study to Assess the Safety and Tolerability of Active Immunotherapy With Escalating Doses of OBI-833/OBI-821 (Globo H-CRM197/OBI-821) in Subjects With Gastric, Lung, Colorectal or Breast Cancer (NCT02310464)

Summary

Antigens are substances that are foreign to the body and that trigger an immune response. An antigen called globo H is found in many types of cancers, including breast cancer. OBI-833 and OBI-821 are two new immunotherapy drugs. They target the globo H antigen, which stimulates the body's immune system to go after cancer cells. This study is evaluating the safety and tolerability of using OBI-833 and OBI-821 to treat metastatic breast (and other) solid tumors.
This is a Phase I trial

MEDI4736 with Lynparza or Cediranib for Advanced Breast (and Other Solid) Tumors

Phase I/II Study of the Anti-Programmed Death Ligand-1 Antibody MEDI4736 in Combination With Olaparib or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Cancer (NCT02484404)

Summary

MEDI4736 (durvalumab) is an immunotherapy drug that works by blocking a protein called PD-L1 (programmed cell death ligand-1). Blocking this protein allows the body's immune system to go after cancer cells. Olaparib (Lynparza®) is a type of cancer drug called a PARP inhibitor. PARP inhibitors interfere with the cancer cells' DNA, making them more sensitive to chemotherapy. Lynparza is used to treat advanced ovarian cancer in women who have an inherited BRCA1/2 mutation. In phase 1 of this study, researchers studied the safety and effectiveness of using MEDI4736, Lynparza or cediranib to treat advanced breast (and other solid) tumors. Phase 1 is now completed. Phase 2 of this study is open to triple-negative breast cancer patients combining MEDI4736 and olaparib. To be eligible, patients must not have previously been treated with PARP inhibitors, PD-1 or PD-L1 inhibitor or an anti-CTLA4 therapy and not have had more than 3 lines of previous treatments for metastatic disease.
This is a Phase I-II trial

An Immunotherapy for Breast Cancer That Has Come Back in the Chest Wall

A Phase II Study Using Talimogene Laherparepvec as a Single Agent for Inflammatory Breast Cancer (IBC) or Non-IBC Patients With Inoperable Local Recurrence (NCT02658812)

Summary

To take part in this study, your breast cancer must have come back (recurred) in your chest wall. In addition, your doctor must have told you that your cancer cannot be removed by surgery. Imlygic (talimogene laherparepvec) is used to treat melanoma. It is a treatment that is injected (like a shot) directly into a tumor site. Imlygic attacks cancer cells directly. It also gets the immune system to kill cancer cells. This study is looking at whether Imlygic can help control breast cancer that has come back in your chest wall.
This is a Phase II trial

Immunotherapy for Metastatic Triple Negative Breast (and Other) Cancers

A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose-Selection Study of CPI-444 as Single Agent and in Combination With Atezolizumab in Patients With Selected Incurable Cancers (NCT02655822)

Summary

Many tumors produce a lot of adenosine, a molecule that interacts with the immune system and keeps immune cells from going after cancer cells. CPI-444 is a new type of immunotherapy drug. It keeps adenosine from being able to tell the immune cells not to go after cancer cells. Atezolizumab (MPDL3280A) is another new immunotherapy drug. It blocks a protein called programmed cell death ligand-1 (PD-L1). Blocking this protein allows the body's immune system to go after cancer cells. This study is looking at the safety and effect of different scheduling cycles for CPI-444 as well as the safety and effect of giving CPI-444 along with MPDL3280A.
This is a Phase I trial

MEDI4736 & Lynparza in Metastatic HER2- Breast Cancer in Women with a BRCA Mutation

A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Olaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors (NCT02734004)

Summary

Olaparib (Lynparza) is a new type of targeted therapy called a PARP inhibitor. It works by blocking the PARP protein from repairing damaged DNA in cancer cells. Lynparza is approved for treating advanced ovarian cancer in women with a BRCA mutation. MEDI4736 is an immunotherapy that blocks PD-L1 (programmed cell death-ligand 1) protein. Blocking this protein stimulates the immune system to go after cancer cells. This study is investigating the safety and effectiveness of using Lynparaza and MEDI4736 together to treat women with HER2-negative metastatic breast cancer who have a BRCA1 or BRCA2 mutation.
This is a Phase I-II trial

Vaccine Plus Herceptin for HER2-Positive Breast Cancer

Combination Immunotherapy With Herceptin and the HER2 Vaccine E75 in Low and Intermediate HER2-expressing Breast Cancer Patients to Prevent Recurrence (NCT01570036)

Summary

Researchers are investigating whether vaccines can play a role in cancer treatment. Trastuzumab (Herceptin®) is used to treat HER2-positive breast cancer. NeuVax® is a vaccine that uses the E75 peptide, which is a piece of the HER2 protein, to get the immune system to identify and kill HER2-positive cancer cells. GM-CSF is a substance added to the vaccine to improve the immune response. This trial will look at whether Herceptin along with the NeuVax vaccine is better than Herceptin alone at preventing recurrence in patients with stage I-III breast cancer who are at high risk for recurrence. To be eligible, participants must have breast cancer with tumors that express low (1+) or intermediate (2+) levels of HER2.
This is a Phase II trial

Immunotherapy Combination for Advanced Triple Negative Breast Cancer

Pilot Study of Durvalumab (MEDI4736) in Combination With Vigil™ in Advanced Breast Cancer (NCT02725489)

Summary

Immunotherapies are designed to get the body's immune system to see and kill cancer cells. Durvalumab (MEDI4736) is an immunotherapy drug. Vigil® is a personalized vaccine designed to teach your immune system to detect and attack your cancer cells. This study is looking at the best dose of Vigil to use along with MED14736. To take part in this study, you must have advanced triple negative breast cancer.
This is a Phase II-III trial

Keytruda with Taxol or Xeloda for Advanced Triple Negative Breast Cancer

A Pilot and Phase II Study to Assess the Safety, Tolerability and Efficacy of Pembrolizumab Plus Chemotherapy in Metastatic Triple Negative Breast Cancer Patients (NCT02734290)

Summary

This study is looking at the safety and effectiveness of using an immunotherapy drug along with a chemotherapy drug to treat breast cancer that cannot be removed by surgery. The immunotherapy drug is pembrolizumab (Keytruda®). It gets the body's immune system to go after cancer cells. The chemotherapy drug will be paclitaxel (Taxol®) or capacitabine (Xeloda®), depending on which group you are put in. Both drugs are commonly used to treat advanced breast cancer. To take part in this study, you must have advanced triple negative breast cancer.
This is a Phase I-II trial

Keytruda with Chemotherapy for Metastatic Triple Negative Breast Cancer

A Randomized Phase II Clinical Trial Assessing the Efficacy and Safety of MK-3475 (Pembrolizumab) in Combination With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer (NCT02755272)

Summary

To take part in this study, you must have metastatic triple negative (ER-/PR-/HER2-negative) breast cancer. Pembrolizumab (Keytruda®) is an immunotherapy drug that gets the immune system to seek out cancer cells. It is used to treat advanced melanoma and metastatic non-small cell lung cancer. Researchers want to learn how well Keytruda works with chemotherapy to treat metastatic triple negative breast cancer. In this study, Keytruda will be combined with two chemotherapy drugs currently used to treat advanced breast cancer that has not responded to other chemotherapy drugs: carboplatin (Paraplatin®) and gemcitabine (Gemzar®).
This is a Phase II trial

Keytruda Plus Radiation for Advanced Triple Negative Breast Cancer

A Single Arm Phase II Study to Assess the Efficacy of Pembrolizumab Plus Radiotherapy in Metastatic Triple Negative Breast Cancer Patients (NCT02730130)

Summary

This study is looking at the safety and effectiveness of using the drug pembrolizumab (Keytruda®) along with radiation therapy to treat advanced breast cancer. To take part, you must have locally recurrent or metastatic triple negative (ER-negative /PR-negative /HER2-negative) breast cancer.

Pembrolizumab (Keytruda®) is an immunotherapy drug. It blocks PD-1, a protein that keeps the immune system from killing cancer cells. External beam radiation is a standard radiation therapy for breast cancer.
This is a Phase II trial

Using Two Immunotherapy Drugs to Treat Metastatic Triple Negative Breast Cancer

A Phase 1b/2 Open-Label Study To Evaluate Safety, Clinical Activity, Pharmacokinetics And Pharmacodynamics Of Avelumab (MSB0010718C) In Combination With Other Cancer Immunotherapies In Patients With Advanced Malignancies (NCT02554812)

Summary

Using two immunotherapy drugs together may kill more cancer cells than using one alone. Avelumab and PF-05082566 are two new immunotherapy drugs now in clinical trials. Both work by blocking a protein called PD-L1. Blocking this protein allows the immune system to find and kill cancer cells. This study is investigating the safety of avelumab and the best dose of it to use along with PF-05082566. To take part in this study, you must have metastatic triple negative (ER-negative, PR-negative, HER2-negative) breast cancer. This study also is enrolling patients with other types of solid tumors. Some of these patients will receive the immunotherapy drug PF-04518600 along with avelumab.
This is a Phase I trial

Mesothelin-Targeted T Cell Immunotherapy for Metastatic Breast Cancer

A Phase I Clinical Trial to Evaluate the Safety and Tolerability of Mesothelin-Specific Chimeric Antigen Receptor-Positive T Cells in Patients With Metastatic Mesothelin-Expressing Breast Cancer (NCT02792114)

Summary

The immune system has two types of white blood cells, B cells and T cells. This study is testing the safety and best dose of an immunotherapy made from your own T cells. Mesothelin is a protein commonly found in breast cancer cells. The mesothelin-targeted T-cell therapy used in this study gets into the cancer cells by attaching itself to these proteins. To take part in this study, you must have HER2-negative metastatic breast cancer and your cancer cells must produce mesothelin proteins. In addition, your doctors must have already used at least one chemotherapy drug to treat your metastatic breast cancer.
This is a Phase I trial

Keytruda with Herceptin or Kadcyla in Advanced Breast (and Other) Cancer

A Phase Ib/II Study of Pembrolizumab and Monoclonal Antibody Therapy in Patients With Advanced Cancer (PembroMab (NCT02318901)

Summary

Pembrolizumab (Keytruda®) is a new immunotherapy agent that works by blocking a protein called programmed cell death (PD-1) that normally keeps the body's immune system from attacking and destroying tumor cells. It has recently approved for treating metastatic melanoma and may also be effective in other types of cancer. Ado-trastuzumab ematansine/T-DM1 (Kadcyla®) is a HER2-targeted therapy that combines the chemotherapy drug DM1 with the HER2-targeted therapy trastuzumab (Herceptin®). In patients with HER2+ metastatic breast cancer, this study will compare the safety and effectiveness of Keytruda and Herceptin with Keytruda and Kadcyla. Patients with other types of cancers will be enrolled in different arms of the study.
This is a Phase I-II trial

Two Immunotherapies for Treating Advanced Breast Cancer

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (INCB 24360-203 / ECHO-203) (NCT02318277)

Summary

Cancer treatments that get your immune system to go after cancer cells are called immunotherapies. This study is looking at the safety and effectiveness of using two immunotherapy drugs at the same time to treat advanced breast cancer. The two drugs being used in this study are epacadostat (INCB024360) and durvalumab (MEDI4736). Epacadostat blocks a protein called IDO1. Durvalumab blocks a protein called PD-L1. To take part in this study, you must have advanced breast cancer and have not yet been treated with an immunotherapy drug that target IDO1 or PD-L1. You must also have had at least one prior treatment for advanced breast cancer or have no other treatments available. This study also is enrolling patients with other types of cancer.
This is a Phase I-II trial

Imbruvica and MEDI4736 in Advanced HER2+ or Triple Negative Breast Cancer

A Multi-Center Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With MEDI4736, in Subjects With Relapsed or Refractory Solid Tumors (NCT02403271)

Summary

Researchers are studying the effectiveness of combining a targeted therapy with an immunotherapy. Ibrutinib (Imbruvica®) is a targeted therapy that is used to treat lymphoma and leukemia. Early studies suggest it may also be effective in breast cancer. MEDI4736 is a type of immunotherapy drug called a PD-1 inhibitor. It works by blocking a signaling pathway that some tumors use to avoid being attacked by the immune system. This study is looking at the safety and efficacy of using Imbruvica and MED14736 to treat advanced HER2-positive or triple negative breast cancer. To be eligible, individuals with breast cancer must have progressed on at least two prior treatments. (The study also is enrolling individuals with advanced pancreatic or non-small cell lung cancer.)
This is a Phase I-II trial

MK-3475 and INCB024360 in Breast Cancer (And Other Solid Tumors)

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of MK-3475 in Combination With INCB024360 in Subjects With Selected Solid Tumors (Phase 1) Followed by a Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Advanced NSCLC (Phase 2) (NCT02178722)

Summary

Researchers are developing new drugs to treat breast cancer and other types of solid tumors. INCB024360 is a new drug that works by blocking an enzyme called IDO1, which suppresses the immune system. Laboratory studies have shown that INCB024360 can activate the immune system and inhibit the growth of cancer cells that express IDO1. MK-3475 (pembrolizumab) is an experimental drug that disables PD-1, a protein that prevents the immune system from attacking tumor cells. Studies suggest that MK-3475 may be an effective treatment for triple negative breast cancer. This study is comparing the safety and effectiveness of the combination of MK-3475 and INCB024360 to MK-3475 and a placebo to treat advanced breast cancer. This study is also enrolling individuals with other types of solid tumors.
This is a Phase I-II trial

Mammaglobin-A DNA Vaccine + Hormone Therapy Before Surgery for ER+, HER2- Breast Cancer

A Phase 1B Randomized Clinical Trial to Evaluate the Safety and Immune Response to a Mammaglobin-A DNA Vaccine in Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy (NCT02204098)

Summary

Mammaglobin-A is a protein that is highly expressed by breast cancer cells. Laboratory studies suggest a mammaglobin-A DNA vaccine may trigger the body's immune system to destroy cancer cells. Hormone therapies are used to treat hormone-sensitive tumors. These medications include anastrozole (Arimidex®), letrozole (Femara®), exemestane (Aromasin®), goserelin (Zoladex®) and tamoxifen. Giving treatment before surgery--called neoadjuvant therapy--allows researchers to study how the cancer responds to the treatment. This study is comparing the immune response seen in women with stage II or III ER-positive, HER2-negative breast cancer who receive a mammaglobin-A DNA vaccine along with hormone therapy or hormone therapy alone before surgery. The type of hormone therapy used will be chosen by the woman's oncologist. To be eligible for the study, a woman must have a breast tumor that expresses mammaglobin-A. In addition, participants must have a tumor Ki67 value of ≤ 10% after 14 days of neoadjuvant hormone therapy in order to be randomized to receive the Mammaglobin-A DNA vaccine.
This is a Phase I trial

Vaccine Therapy for HER2+ Metastatic Breast Cancer

Phase I Active Immunotherapy Trial With a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like) HER-2 B Cell Peptide Vaccine Emulsified in ISA 720 and Nor-MDP Adjuvant in Patients With Advanced Solid Tumors (NCT01376505)

Summary

Researchers are studying whether vaccines can teach the body’s immune system to kill cancer cells. About 30% of all breast tumors make too much of a protein called human epidermal growth factor receptor 2 (HER2). Scientists believe a vaccine that incorporates a small amount of the HER2 protein may get the immune system to recognize and go after HER2+ cancer cells. The purpose of this trial is to determine the best dose for and the side effects of a new HER2 vaccine when it is used to treat individuals with HER2+ metastatic breast cancer.
This is a Phase I trial

LY3022855 for Advanced Breast (and Prostate) Cancer

Phase 1 Study to Identify the Immunomodulatory Activity of LY3022855 (IMC-CS4) in Patients With Advanced, Refractory Breast or Prostate Cancer (NCT02265536)

Summary

Cancer immunotherapies work by getting the immune system to attack cancer cells. LY3022855 (IMC-CS4) is a type of immunotherapy called a monoclonal antibody. It targets the colony-stimulating factor 1 receptor (CSF1R), which plays an important role in cell survival. This study will allow researchers to learn how LY3022855 affects the immune system in patents with advanced breast (or prostate) cancer. To be eligible, a patient must have had their tumor progress on or not respond to at least one prior therapy.
This is a Phase I trial

NeuVax and Herceptin to Reduce Recurrence in High-Risk HER2+ Breast Cancer Patients

Phase II Trial of Combination Immunotherapy With Nelipepimut-S + GM-CSF (NeuVax™) and Trastuzumab in High-risk HER2+ Breast Cancer Patients (NCT02297698)

Summary

Researchers are developing vaccines that can be used as cancer treatments. NeuVax™ (nelipepimut-S + GM-CSF) is a vaccine that teaches the immune system to kill HER2-positive cancer cells. GM-CSF (sargramostim/Leukine) is a substance added to the vaccine to improve the immune response. Trastuzumab (Herceptin®) is a targeted therapy used to treat HER2+ tumors. This study is comparing the effectiveness of Herceptin and NeuVax to Herceptin and GM-CSF for preventing a recurrence in high-risk patients. High risk includes patients whose tumors did not shrink completely after receiving treatment with Herceptin before breast cancer surgery; or who had ≥ 4 positive lymph nodes found at the time of surgery; or who are ER/PR-negative and had 1-3 positive lymph nodes found during surgery. Patients interested in this study will have their blood type tested. Because of how the vaccine works, only patients whose blood is HLA-2+ or HLA-A3+ will be considered eligible.
This is a Phase II trial

Telomerase DNA Immunotherapy After Surgery and Adjuvant Therapy to Reduce Recurrence

A Study of hTERT Immunotherapy Alone or in Combination With IL12 DNA Followed by Electroporation in Adults With Breast, Lung, or Pancreatic Cancer at High Risk of Relapse Post Definitive Surgery and Adjuvant Therapy (NCT02327468)

Summary

INO-1400 is a new immunotherapy targeting the hTERT (human telomerase reverse transcriptase), which is found in 85% of cancer cells. (It is rare in normal cells.) Electroporation uses controlled, millisecond electrical pulses to create temporary pores in the cell membrane. After being injected into the muscle or skin, the DNA immunotherapy is absorbed into these pores. This study is evaluating the safety, tolerability, and immunogenicity of INO-1400, followed by electroporation, in breast cancer patients who have no evidence of disease after surgery and adjuvant therapy but are considered to be high risk for recurrence. (This trial also is enrolling patients with lung and pancreatic cancer.)
This is a Phase I trial