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Vaccines and Immunotherapy

Taxotere & A New Immune Therapy in Metastatic Breast Cancer

A Phase II Double-Blinded, Randomized, Placebo-Controlled Study of Docetaxel in Combination With 1-methyl-D-tryptophan (Indoximod) in Metastatic Breast Cancer (NCT01792050)

Summary

Researchers are studying news types of drugs and new drug combinations that could be used to treat metastatic breast cancer. Docetaxel (Taxotere®) is routinely used to treat breast cancer. Indoximod is a new type of drug called an IDO pathway inhibitor. It works by blocking an enzyme called IDO that plays a role in the immune system. Laboratory studies suggest that giving IDO along with Taxotere can make the Taxotere more effective. The purpose of this study is to see whether combining Taxotere and Indoximod is more effective than using Taxotere alone to treat metastatic breast cancer.
This is a Phase II trial

What's Involved    Contact information

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

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

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

Bavituximab and/or a Taxane for Metastatic HER2-Negative Breast Cancer

An Open-Label, Randomized, Phase II/III Trial of Taxane Therapy With or Without Bavituximab for the Treatment of HER2-Negative Metastatic Breast Cancer (NCT02651610)

Summary

Bavituximab is an investigational immunotherapy called a monoclonal antibody. Paclitaxel (Taxol®) and docetaxel (Taxotere®) are taxane-based chemotherapy drugs routinely used to treat breast cancer. This study is comparing the safety and effectiveness of bavituximab and a taxane to a taxane alone to treat metastatic HER2-negative breast cancer. In the study, the participant's physician will choose which taxane will be given.

  • Participation TimeVisits at least weekly
  • 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 (PD-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

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

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

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

Individualized Immunotherapy for Metastatic Breast (and Other) Cancer

A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab (NCT01174121)

Summary

Tumor infiltrating lymphocytes (TILs) are the white blood cells that are found in tumors. The immune system has activated these cells to try to control the cancer's growth. This study is investigating a new type of immunotherapy in which researchers take TILs from tumors, grow the ones that are most effective in fighting the cancer in the laboratory, and then give the cells back to the patient. Previous studies using TIL in melanoma have shown effectiveness in shrinking the tumor. In this study, researchers will study the effectiveness of TIL in shrinking breast (and other) tumors. To be eligible, patients must have tumors that can be surgically removed. The study requires patients to stay in the hospital for about 4 weeks.

  • Participation TimeHospital stay for about 4 weeks
  • 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

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

What's Involved    Contact information

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

What's Involved    Contact information

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

What's Involved    Contact information

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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AVX901: A Vaccine for Advanced HER2-Positive Breast Cancer

A Phase I Study To Evaluate The Antitumor Activity And Safety Of DUKE-002-VRP(HUHER2-ECD+TM), An Alphaviral Vector Encoding The HER2 Extracellular Domain And Transmembrane Region, In Patient With Locally Advanced Or Metastatic ... (NCT01526473)

Summary

New approaches are needed for treating HER2-positive tumors. A vaccine that teaches the immune system to go after cancer cells may be an effective cancer treatment. The experimental vaccine AVX901 (HER2 VRP) teaches the immune system to attack cells that make too much HER2. Normal cells do not do this, so the immune system will only go after the cancer cells. The purpose of this study is to evaluate the vaccine's safety as well as its ability to get the immune system to attack cancer cells in women with advanced HER2+ breast 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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