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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

What's Involved    Contact information

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.

  • Participation Time2 visits every 3 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

  • Participation TimeAt least weekly visits
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

  • Participation Time4 visits over 3 weeks, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

  • Participation TimeVisits every 3 weeks, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

What's Involved    Contact information

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 (PDL-1) 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

What's Involved    Contact information

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

What's Involved    Contact information

Immunotherapy for the Treatment of Breast Cancer-Related Lymphedema

Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL) (NCT02494206)

Summary

Lymphedema–a painful swelling of the arm and hand—is a common side effect of breast cancer treatment. QBX258 (combination of VAK296 and QAX56) is a new type of immunotherapy that may help reduce lymphedema symptoms by engaging the body's natural inflammatory response. This study is investigating the efficacy of QBX258 in women with stage I-II breast cancer who develop lymphedema following breast cancer treatment. To be eligible, a woman must have a body-mass index (BMI) between 18 and 30.

  • Participation TimeVisits every 4 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

  • Participation TimeVisits every 3 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

  • Participation Time7 visits over 15 months
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

  • Participation TimeVisits every 3 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

  • Participation TimeAt least 8 visits over 6 months
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

  • Participation TimeVisits every 3 weeks, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

  • Participation Time7 visits over 6 months
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

  • Participation TimeAt least 2 visits per month, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

What's Involved    Contact information

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.

  • Participation TimeVisits every 3 weeks, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

  • Participation TimeVisits every 3-4 weeks, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

ID-LV305 for Advanced Cancers With the NY-ESO-1 Protein

A Phase 1, Open-Label Clinical Trial Evaluating the Safety, Tolerability and Immunogenicity of Intradermally Administered ID-LV305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1 (NCT02122861)

Summary

Researchers are developing drugs that use the immune system to fight cancer. The NY-ESO-1 protein is expressed by some types of cancer, including breast cancer. Killer T cells are a type of white blood cell. ID-LV305 is a new drug that teaches killer T cells to attack tumor cells that express the NY-ESO-1 protein. This is the first-in-human study of NY-ESO-1. The goal of this study is to identify the best dose of ID-LV305 for treating tumors that express the NY-ESO-1 protein. Individuals interested in the trial will have their tumor tested for the NY-ESO-1 protein, to see if they are eligible. This study is enrolling individuals with breast and other types of cancer.
This is a Phase I trial

What's Involved    Contact information

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.

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

  • Participation TimeAt least 1 visit every 2 months
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Effect of a Cancer Vaccine & Herceptin Given Before Surgery on HER2+ DCIS

A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS (NCT02336984)

Summary

HER-2 positive ductal carcinoma in situ (DCIS) is associated with a greater risk of recurrence. Dendritic cell (DC) vaccines are made from each patient's own immune cells. Cells are collected and used to produce a vaccine that is just for them. Trastuzumab (Herceptin®) is a HER2-targeted therapy used to treat HER2+ invasive breast cancer. This study is looking at the effect that a DC1 vaccine and Herceptin have on DCIS when it is given before surgery to patients with HER2+ tumors. Patients with ER+ DCIS will also be given an anti-estrogen therapy prior to surgery.
This is a Phase I-II trial

What's Involved    Contact information

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.

  • Participation TimeVisits monthly for 4 months then every 2 weeks for 9 months
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

  • Participation Time1 visit per month for 4 months, then every 2 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

What's Involved    Contact information

MEDI4736 and Tremelimumab for Advanced Triple-Negative Breast Cancer

A Phase I Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Solid Tumors (NCT02261220)

Summary

Researchers are developing new drugs that are designed to get the immune system to recognize and attack specific targets on cancer cells. MEDI4736 is a new type of drug called a PD-1 inhibitor. It blocks a signaling pathway that some tumors use to avoid being attacked by the immune system. Tremelimumab is a new type of drug that activates the immune system by blocking a protein called CTLA-4. This study is evaluating the safety, efficacy and and best dose of MEDI4736 when it is given in combination with tremelimumab for treating advanced triple negative breast cancer and other types of solid tumors.
This is a Phase I trial

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites: 7 sites total Contact information
What's Involved    Contact information

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.

  • Participation TimeCoincides with chemotherapy or immunotherapy, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

  • Participation TimeVisits every other week up to 1 year
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

GDC-0919 and Atezolizumab for Advanced Breast (and Other Solid) Tumors

A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0919 Administered With MPDL3280A in Patients With Locally Advanced or Metastatic Solid Tumors (NCT02471846)

Summary

GDC-0919 is an experimental immunotherapy drug that works by inhibiting a protein that is often overproduced by cancer cells. Atezolizumab (MPDL3280A) is a new immunotherapy drug that blocks the PD-L1 protein. Blocking this protein allows the body's immune system to go after cancer cells. This study is evaluating the safety, best dose, and tolerability of using GDC-0919 and atezolizumab to treat advanced triple-negative breast cancer. To be eligible, a patient must have locally advanced, recurrent, or metastatic breast cancer for which there is no standard therapy available. This study is also enrolling individuals with other types of advanced cancer.

  • Participation TimeVisits every 3 weeks, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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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

  • Participation Time10 visits over 6 months
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Actimmune and Opdivo for Metastatic Breast (and Other) Solid Tumors

Combination Immunotherapy With Interferon-gamma and Nivolumab for Patients With Advanced Solid Tumors: A Phase 1 Study (NCT02614456)

Summary

Nivolumab (Opdivo®) is an immunotherapy drug used to treat metastatic melanoma. It blocks a protein called PD-1 (programmed cell death-1). By blocking this protein, immune cells are able to go after cancer cells. Interferon-gamma (IFN-γ) is a small protein called a cytokine. Immune cells produce IFN-γ to help prevent infection. Actimmune is the synthetic version of IFN-γ. This study is evaluating the safety and effectiveness of using Actimmune and Opdivo alone and in combination to treat metastatic breast (and other) solid tumors that have progressed on at least one prior systemic therapy. PLEASE NOTE: As of 3/1/2016, there are limited enrollment for breast cancer patients. The first cohorts are already complete, and second cohort has a waitlist, with planned re-opening in April at earliest. Please contact the research site for more information: 215-728-3889.
This is a Phase I trial

  • Participation TimeVisits at least every other day, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Combination Immunotherapy Treatment for Advanced Breast (and Other Solid) Tumors

OPEN-LABEL, MULTICENTER, DOSE ESCALATION PHASE IB STUDY WITH EXPANSION PHASE TO EVALUATE THE SAFETY, PHARMACOKINETICS AND ACTIVITY OF RO5509554 AND MPDL3280A ADMINISTERED IN COMBINATION IN PATIENTS WITH ADVANCED SOLID TUMORS (NCT02323191)

Summary

MPDL3280A and RO5509554 are two experimental immunotherapies. MPDL3280A targets the PD-L1 (programmed cell death ligand-1) protein. RO5509554 blocks the CSF1R (colony stimulating factor 1-receptor) protein on white blood cells. This study is evaluating the safety and effectiveness of using RO5509554 and MPDL3280A together to treat locally advanced or metastatic breast (and other solid) tumors. To be eligible, participants must have no standard therapy available.
This is a Phase I trial

  • Participation TimeVisits every 3 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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-1 (programmed cell death 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. Cediranib is an angiogenesis inhibitor that keeps cancer cells from growing the blood vessels they need to survive. In phase 1 of this study, researchers will study the safety and effectiveness of using MEDI4736, Lynparza and cediranib to treat advanced breast (and other solid) tumors. Phase 2 of this study is not open to breast cancer patients. To be eligible, patients must not have previously been treated with a PD1 or PD-L1 inhibitor or an anti-CTLA4 therapy.
This is a Phase I-II trial

  • Participation TimeVisits every 2 weeks for 1 year
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

An IDO Inhibitor Immunotherapy for Advanced Breast (and other solid) Tumors

A Phase I Study of NLG-919 for Adult Patients With Recurrent Advanced Solid Tumors (NCT02048709)

Summary

Tumor cells have ways to ward off the immune system. Researchers are designing cancer therapies that can override this ability and get the immune system to go after cancer cells. Laboratory studies have found that tumors use a pathway called IDO to escape the immune system. NLG919 is a new immunotherapy drug that is designed to boost the immune system by inhibiting the IDO pathway. The purpose of this study is to determine the safety and best dose of NLG919 for treating advanced breast cancer (and other solid tumors) in patients who have no other approved treatment options.
This is a Phase I trial

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MEDI4736 & Lynparaza 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 (Lynparaza) 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. Lynparaza is approved for treating advanced ovarian cancer in women with a BRCA mutation. MEDI4736 is an immunotherapy that blocks PD-L1 (programmed cell death-ligand1) 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

  • Participation TimeVisits monthly, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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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

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Vaccine Therapy for DCIS

Vaccine Therapy in Treating Patients With Ductal Carcinoma In Situ of the Breast (NCT00923143)

Summary

Researchers are investigating whether a vaccine can be used to treat ductal carcinoma in situ (DCIS). One vaccine now being studied is made from a patient's own T-cells, which are a type of white blood cell. To make the vaccine, the researchers remove the patients T-cells. Next, they coat the T-cells with special proteins that make them into a vaccine that can teach other white blood cells to go after and kill cancer cells. Then, they inject the vaccine into the patient's body. This trial is studying the safety and effectiveness of two different injection sites (in the breast or in a lymph node) for the vaccine in individuals with DCIS that is HER2-positive.
This is a Phase I-II trial

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A Breast Cancer Vaccine for Metastatic or Triple-Negative Breast Cancer

Clinical Trial of Autologous cMet Redirected T Cells Administered Intratumorally in Patients With Breast Cancer (NCT01837602)

Summary

Researchers are investigating whether they can use vaccines to teach the immune system to go after cancer cells. This study will test a vaccine developed for each patient by adding special genetic material to T-cells that are removed from and then infused back into the body. The genetic material teaches the T-cells to fight cancer cells. To be eligible, participants must have either metastatic breast cancer that has stopped responding to at least one standard therapy or newly diagnosed operable triple negative breast cancer.
This is a Phase I trial

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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

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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

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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

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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

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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

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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

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Dendritic Cell Vaccine After Neoadjuvant Therapy for HER2+ Breast Cancer

Pilot Phase I HER-2 Pulsed DC Vaccine to Prevent Recurrence for Patients With HER-2 Driven High Risk Invasive Breast Cancer Post Neoadjuvant Chemotherapy (NCT02061423)

Summary

Dendritic cells are immune cells that break down cancer cells into smaller pieces. This makes it easier for the immune system to recognize and attack cancer cells. The process of making a dendritic cell vaccine includes taking immune cells from the patient with cancer, treating the cells in the lab, and then infusing the cells back into the body, where they should provoke an immune response to the patient's cancer cells. This study is investigating the safety and immune activity of a dendritic cell vaccine in patients with HER2-positive breast cancer who are at high risk for recurrence because they still have cancer cells remaining following neoadjuvant therapy (therapy given before surgery).
This is a Phase I trial

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