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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

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

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, a breast cancer patient must have progressed on at least two prior treatments. (The study also is enrolling patients with advanced pancreatic or non-small cell lung cancer.)
This is a Phase I-II trial

A Vaccine to Treat HER2+ Advanced Breast Cancer

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

Summary

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

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 in patients with metastatic breast cancer.
This is a Phase II trial

Vaccine for Metastatic Breast Cancer

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

Summary

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

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. Patients 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 patients with breast and other types of cancer.
This is a Phase I trial

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

A Breast Cancer Vaccine & Chemo Before Surgery in Early-Stage 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

Pembrolizumab (MK-3475) For Advanced Breast Cancer & Other Solid Tumors

Phase IB Study of MK-3475 in Subjects With Select Advanced Solid Tumors (NCT02054806)

Summary

Researchers are developing new ways of treating cancer. Pembrolizumab (MK-3475) is a new type of cancer drug that helps the body's immune system slow or stop cancer cell growth by blocking a protein known as programmed death receptor (PD-1). Pembrolizumab has been shown to be effective in treating advanced melanoma. This trial is examining the efficacy and safety of pembrolizumab when it is used to treat patients with advanced breast cancer—or other types of solid tumors—who have stopped responding to treatment or have no standard treatment available.
This is a Phase I trial

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

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

Summary

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

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

Vaccine Therapy, Herceptin and Polysaccharide-K in HER2+ Metastatic Disease

Phase I/II Randomized Study of Combination Immunotherapy With or Without Polysaccharide Krestin (PSK®) Concurrently With a HER2 ICD Peptide-Based Vaccine and Trastuzumab in Patients With Stage IV Breast Cancer (NCT01922921)

Summary

Researchers are developing vaccines that teach the immune system to attack cancer cells. The HER2 vaccine used in this study teaches the immune system to kill tumor cells that express HER2. Trastuzumab (Herceptin®) is routinely used to treat HER2+ breast cancer. Polysaccharide-K is a molecule that can stimulate the immune system. The HER2 vaccine may generate a stronger immune response when it is given with polysaccharide-K. This trial is comparing the effectiveness and the immune response seen in patients with metastatic HER+ breast cancer who are given the HER2 vaccine and Herceptin with those who are given the HER2 vaccine, Herceptin and polysaccharide-K.
This is a Phase I-II trial

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

Evaluating the Safety of Vaccine For Early Stage Breast Cancer

A Pilot Study of the Immunogenicity of a 9-Peptide Breast Cancer Vaccine Plus Poly-ICLC in Stage IB-IIIA Breast Cancer (NCT01532960)

Summary

Despite treatment advances, some patients with early stage breast cancer will go on to experience a recurrence. Because a recurrence may not happen for many years, there is a period of time after surgery when a breast cancer vaccine may be able to stop potential metastases from spreading. Researchers are exploring whether peptides consisting of small protein fragments associated with breast cancer can stimulate immune cells such as cytotoxic T lymphocytes to kill tumor cells. This study is investigating whether a vaccine that contains breast specific peptides can trigger an immune response in participants with early stage (stage IB to IIIA) breast cancer. To be eligible, participants must have completed treatment for breast cancer between 45 days and 6 months (180 days) prior to enrollment.

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

Stereotactic Radiation for Lung or Liver Metastases

Phase I/II Study of Stereotactic Body Radiation Therapy to Metastatic Lesions in the Liver or Lung in Combination With Monoclonal Antibody to OX40 in Patients With Progressive Metastatic Breast Cancer After Systemic Therapy. (NCT01642290)

Summary

Stereotactic body radiation therapy (SBRT) is a technique that delivers high-dose, focused radiation to treat small, isolated tumors, including cancers in the lung and liver. SBRT systems are often referred to by their brand names, such as CyberKnife®. The anti-OX40 monoclonal antibody has been studied in patients with advanced solid tumors. Studies suggest that activating the immune system with OX40 can help shrink tumors. This is a phase I/II study to determine the maximum tolerated dose of stereotactic body radiation given with anti-OX40 in patients with tumors that have spread to to the lung or liver.
This is a Phase I-II trial

Combining Two Immunotherapy Drugs to Treat Advanced Breast (or Ovarian) Cancer

A Phase 1b Study of ONT 10 and Varlilumab in Patients With Advanced Ovarian Cancer or Breast Cancer (NCT02270372)

Summary

Researchers are looking for ways to get the body's immune system to recognize and fight cancer cells. ONT-10 is an immunotherapy that targets MUC1, an antigen that is found at higher than normal levels in many types of cancers, including breast and ovarian cancer. Varlilumab (CDX-1127) is an immunotherapy that uses a monoclonal antibody to target a molecule called CD27 that helps T-cells recognize and kill cancer cells. This study is designed to determine the safety and best dose of ONT-10 to use along with varlilumab to treat advanced breast (and ovarian) cancer. To be eligible for this study, a patient must have previously tried routine cancer treatments.
This is a Phase I trial

FANG Vaccine For Advanced Breast Cancer

Phase I Trial of Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine for Advanced Cancer (NCT01061840)

Summary

Studies suggest that vaccines that enable the body to build an immune response to tumor cells might be effective and have few side effects. The FANG (bi-shRNAfurin and GMCSF autologous tumor cell) vaccine works by stimulating tumor surface proteins, which then increases the number of immune cells that attack breast cancer cells with these proteins. The goal of this trial is to study the safety of and tumor response to the FANG vaccine in individuals with advanced breast cancer who have no acceptable form of standard therapy.
This is a Phase I trial

Vaccine With Basilixumab for Metastatic Breast Cancer

A Study of hTERT/Survivin Multi-Peptide Vaccination With Basiliximab And Prevnar For Patients With Metastatic Breast Cancer (NCT01660529)

Summary

Researchers believe that vaccines may be effective cancer treatments. Recent observations support the idea that the enzyme telomerase is essential for the formation of human tumors. In a recent study, three-quarters of breast tumors tested positive for human telomerase reverse transcriptase (hTERT). Researchers believe that a vaccine that teaches the immune system to target hTERT may be an effective breast cancer treatment. This study is testing a hTERT/survivin/CMV multipeptide vaccine in women with metastatic breast cancer. The vaccine is given along with the monoclonal antibody basiliximab, GM-CSF and Prevnar, which each work in different ways to help the immune system target the cancer cells.

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

Breast Cancer Vaccine Therapy With or Without Trastuzumab

Cyclophosphamide and Vaccine Therapy With or Without Trastuzumab in Treating Patients With Metastatic Breast Cancer (NCT00971737)

Summary

Cancer vaccines may help the body build an effective immune response to tumor cells. Cyclophosphamide (Cytoxan®) is a chemotherapy drug used to treat breast cancer. Trastuzumab (Herceptin®) is a biological therapy used to treat HER2+ tumors. Both work in a way that may increase the number of immune cells and make the immune response stronger. It is not yet known whether giving cyclophosphamide together with vaccine therapy is more effective with or without trastuzumab (Herceptin®). This trial is studying the safety and effectiveness of giving cyclophosphamide with vaccine therapy with or without trastuzumab in women with HER2-negative metastatic breast cancer who have progressed on standard therapy, or for whom no standard therapy exists.
This is a Phase II trial

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

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

Summary

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

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

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

A Study of Two New Peptide Vaccines for Reducing Risk of Recurrence

Phase Ib Trial of Two Folate Binding Protein (FBP) Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients (NCT02019524)

Summary

Researchers are trying to develop vaccines that reduce the risk of a cancer recurrence. E39 and J65 are folate-binding protein peptide vaccines. Laboratory studies suggest these vaccines may be effective in patients with breast or ovarian cancer whose blood tests positive for the HLA-A2 antigen. This study is designed to determine the most effective way to give patients with breast or ovarian cancer the E39 and J65 vaccines. To be eligible, patients must have completed treatment for breast or ovarian cancer and have no evidence of disease. Patients will have their blood tested for the HLA-A2 antigen. Only those who are HLA-A2+ will be enrolled in the study. (Approximately 50% of the U.S. population is HLA-A2+).
This is a Phase I-II trial