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Vaccines and Immunotherapy

Keytruda plus Abraxane Before Surgery for ER+ or PR+ Stage II or III Breast Cancer

A Pilot Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer (NCT02999477)

Summary

To take part in this study, you must have HR-positive (ER+ and/or PR+), HER2-negative stage II or III breast cancer that can be removed by surgery. This study is investigating the safety and effect of different combinations of Keytruda® and Abraxane® when they are given before surgery to patients with stage II or III breast cancer. Pembrolizumab (Keytruda®) is an immunotherapy drug. It gets the body's immune system to go after cancer cells by blocking a protein called programmed cell death (PD-1). It is currently approved to treat certain types of melanoma, head and neck cancer, lung cancer and Hodgkin lymphoma. Nab-paclitaxel (Abraxane®) is a chemotherapy drug approved to treat metastatic breast cancer in patents who have already tried other cancer treatments.
This is a Phase II trial

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

Immunotherapy Before Surgery for HR+, HER2- Stage II-III Breast Cancer

A Pilot Pre-Surgical Study Evaluating Anti-PD-L1 Antibody (Durvalumab [MEDI4736]) Plus Anti-CTLA-4 Antibody (Tremelimumab) in Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer (NCT03132467)

Summary

To take part in this study, you must have HR-positive (ER+/PR+) and HER2-negative stage II or stage III breast cancer. You must also be planning to receive treatment before surgery (called neoadjuvant treatment). This study is investigating the the safety and effects (good and bad) that two immunotherapy drugs have on breast tumors when given before surgery. The two immunotherapy drugs are tremelimumab and duralumab (Imfinzi). Tremelimumab has not been approved for any types of cancer. Imfinzi is approved to treat a certain type of bladder cancer.

Carboplatin plus Atezolizumab for Metastatic Triple Negative Breast Cancer

A Phase II Trial of Atezolizumab (Anti-PDL1) With Carboplatin in Patients With Metastatic Triple Negative Breast Cancer (NCT03206203)

Summary

To take part in this study, you must have metastatic (stage IV), triple negative (ER-/PR-/HER2-) breast cancer. This study is investigating whether using a combination of immunotherapy and chemotherapy is better than using chemotherapy alone to treat triple negative metastatic breast cancer. Carboplatin (Paraplatin®) is the chemotherapy drug used in this study. Atezolizumab (Tecentriq®) is the immunotherapy drug used in this study.
This is a Phase II trial

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

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

Summary

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

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

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

Summary

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

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

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

Summary

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

Keytruda & Decitabine Followed by Chemo Before Surgery for Locally Advanced HER2- Disease

T-Cell Immune Checkpoint Inhibition Plus Hypomethylation for Locally Advanced HER2-Negative Breast Cancer - A Phase 2 Neoadjuvant Window Trial of Pembrolizumab and Decitabine Followed by Standard Neoadjuvant Chemotherapy (NCT02957968)

Summary

To take part in this study, you must have HER2-negative locally advanced (some stage III) breast cancer. Giving chemotherapy before surgery (called neoadjuvant treatment) can shrink the tumor. It also allows researchers to study the effect the treatment has on the cancer cells. This study will evaluate the safety and effectiveness of using immunotherapy before standard neoadjuvant chemotherapy. The immunotherapy used in this study is pembrolizumab (Keytruda®). It is approved to treat certain types of metastatic lung cancer. It will be given along with the chemotherapy drug decitabine (Dacogen®), which is used to treat a certain type of blood cancer.
This is a Phase II trial

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

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

Summary

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

Atezolizumab & Abraxane for Triple Negative Stage I-III Breast Tumors

Triple-Negative First-Line Study: Neoadjuvant Trial of Nab-Paclitaxel and MPDL3280A, a Pdl-1 Inhibitor in Patients With Triple Negative Breast Cancer (NCT02530489)

Summary

MPDL3280A (atezolizumab) is an new immunotherapy drug that stimulates the body's immune system to go after cancer cells. It works by blocking a protein called programmed cell death ligand-1 (PD-L1) that normally keeps the body's immune system from attacking and destroying tumor cells. Nab-paclitaxel (Abraxane®) is a chemotherapy drug routinely used to treat advanced breast cancer. This study is looking at the safety and effectiveness of using atezolizumab and Abraxane before surgery and then using atezolizumab after surgery to treat stage I-III triple-negative breast cancer. Participants must have not had significant tumor shrinkage from enrollment in another study at M.D. Anderson (NCT02276443) to be eligible for this study.
This is a Phase II trial

Keytruda and Abraxane in HER2-Negative Metastatic Breast Cancer

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

Summary

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

Tecentriq plus Taxol, Herceptin and Perjeta for HER2+ Advanced Breast Cancer

Single Arm, Phase IIA Clinical Trial Assessing The Safety And Efficacy of Atezolizumab in Combination With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer (NCT03125928)

Summary

To take part in this study, you must have HER2-positive advanced (some stage III) or metastatic (stage IV) breast cancer. This study will evaluate the safety and effectiveness of adding an immunotherapy to the standard treatment for HER2-positive advanced breast cancer. Atezolizumab (Tecentriq®) is the immunotherapy drug used in this study. It is approved to treat bladder cancer and a type of lung cancer. The standard of care for HER2+ advanced breast cancer treatment is the chemotherapy drug paclitaxel (Taxol®) and the HER2-targeted drugs trastuzumab (Herceptin®) and pertuzumab (Perjeta®).
This is a Phase II trial

Keytruda Before and After Surgery plus Chemo for Triple Negative Breast Cancer

A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC) (NCT03036488)

Summary

To take part in this study, you must have locally advanced triple negative (ER-/PR-/HER2-) breast cancer. This study is looking at whether it is beneficial to give an immunotherapy drug along with chemotherapy before and after surgery to women with locally advanced triple negative breast cancer. The immunotherapy drug being used in this study is pembrolizumab (Keytruda®). It is an immunotherapy drug that blocks the programmed cell death (PD-1) protein. You will be randomly assigned to receive either paclitaxel (Taxol®), carboplatin (Paraplatin®), and doxorubicin (Adriamycin®) OR epirubicin (Ellence®), and cyclophosphamide (Cytoxan®). Both regimens are used to treat triple negative breast cancer.
This is a Phase III trial

Keytruda plus Chemotherapy in Advanced Triple Negative Breast Cancer

A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer - (KEYNOTE-355) (NCT02819518)

Summary

To take part in this study, you must have stage III breast cancer that has come back (recurred) or stage IV (metastatic) triple negative (ER-/PR-/HER2-) breast cancer. You must not have been treated with chemotherapy. This study is investigating whether chemotherapy drugs that kill cancer cells work better if they are given along with a drug that gets the immune system to kill cancer cells (immunotherapy.) If you enroll, you will be put into one of two groups. One group will receive Keytruda and a chemotherapy drug. The other group will receive a placebo and a chemotherapy drug. You have the same chance of being put into either group. The immunotherapy drug being used in this study is pembrolizumab (Keytruda®). The chemotherapy drugs are paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), gemcitabine (Gemzar®), and carboplatin (Paraplatin®). You will receive one of these chemotherapy drugs.
This is a Phase III trial

Keytruda plus Two Chemotherapies for Metastatic Triple-Negative Breast Cancer

Pilot Study of Carboplatin, Nab-Paclitaxel and Pembrolizumab for Metastatic Triple-Negative Breast Cancer (NCT03121352)

Summary

To take part in this study, you must have metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. You cannot have had more than two prior therapies for your metastatic diagnosis. This study will determine the effectiveness of giving two chemotherapy drugs along with an immunotherapy drug. The immunotherapy drug used in this study is pembrolizumab (Keytruda®). It is approved to treat some types of metastatic cancer. Carboplatin (Paraplatin®) and nab-paclitaxel (Abraxane®) are chemotherapy drugs routinely used to treat advanced breast cancer.
This is a Phase II trial

INT230-6 Injections & Immunotherapy for Treating Advanced Breast Cancer

A Phase 1/2 Safety Study of Intratumorally Administered INT230-6 in Adult Subjects With Advanced Refractory Cancers (NCT03058289)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer and have at least one tumor that can be felt by your doctor or seen on a scan by your radiologist. You also must have tried all other available treatments. INT230-6 is a combination chemotherapy treatment that is injected directly into the tumor. The first part of this study will determine the best dose of INT230-6. The second part will investigate how tumors respond to the best dose of INT230-6 when it is given with an anti-PD-1 immunotherapy. INT230-6 contains the chemotherapy drugs cisplatin (Platinol®) and vinblastine (Velban®) along with a substance that makes them more effective. This study is also recruiting patients with other types of advanced cancers.
This is a Phase I-II trial

Immunotherapy & Chemo Before Surgery for Early Stage Breast Cancer

A Phase Ib Study to Assess the Safety, Tolerability and Immunologic Activity of Preoperative IRX 2 In Early Stage Breast Cancer (NCT02950259)

Summary

To take part in this study, you must have been diagnosed with early stage (stage I-III) breast cancer and be planning to have a lumpectomy or mastectomy as part of your breast cancer treatment. This trial is studying the safety and effects (good or bad) of a new immunotherapy. Giving the treatment before surgery allows the researchers to study the effect the drug has on breast cancer cells. Patients in this study will also receive one chemotherapy treatment before surgery. The immunotherapy drug being used in this study is called IRX-2. The chemotherapy drug is cyclophosphamide (Cytoxan®). It is routinely used to treat breast cancer. You will also be asked to take an anti-inflammatory drug (indomethacin), an anti-acid drug (omeprazole), and a multivitamin.
This is a Phase I trial

Halaven plus Keytruda for HR+ Metastatic Breast Cancer

A Randomized Phase II Study Of Eribulin Mesylate With Or Without Pembrolizumab For Metastatic Hormone Receptor Positive Breast Cancer (NCT03051659)

Summary

To take part in this study, you must have HR+ metastatic (stage IV) breast cancer. This study is evaluating the safety and effectiveness of combining a chemotherapy drug with an immunotherapy drug. The immunotherapy drug being used in this study is pembrolizumab (Keytruda®). It is approved to treat certain types of melanoma, lung, head and neck cancers, and blood cancers. The chemotherapy drug being used in this study is eribulin mesylate (Halaven®). It is approved for treating metastatic breast cancer.
This is a Phase II trial

Cytoxan plus Keytruda for Metastatic Triple Negative Breast Cancer

Phase II Study Of Single-dose Cyclophosphamide +Pembrolizumab In Patients With Metastatic Triple Negative Breast Cancer (NCT02768701)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) metastatic breast cancer and have already received at last one prior treatment for your metastatic cancer. This study is looking at the effectiveness of combining a chemotherapy drug with an immunotherapy drug. The chemotherapy drug being used in the study is cyclophosphamide (Cytoxan®). It is commonly used to treat breast cancer. The immunotherapy drug is pembrolizumab (Keytruda®). It is approved for treating metastatic melanoma.
This is a Phase II trial

Imlygic™ plus Chemo Before Surgery for Stage II-III Triple Negative Breast Cancer

A Phase 1/2 Study of Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer (NCT02779855)

Summary

To take part in this study, you must be newly diagnosed with stage II or III triple negative (ER-/PR-/HER2-) breast cancer. This study is investigating the best dose of the drug talimogene laherparepvec (Imlygic™) to use along with chemotherapy before surgery. (Treatment before surgery is called neoadjuvant therapy.) Imlygic is a herpes virus that has been genetically modified to destroy cancer cells. It also works as an immunotherapy. The drug, which is injected directly into the tumor, is approved for treating melanoma. It will not cause you to develop herpes. The chemotherapy regimen that will be used in this study is ACT (doxorubicin/Adriamycin®, cyclophosphamide/Cytoxan®, paclitaxel/Taxol®). It is routinely used to treat triple negative breast cancer.
This is a Phase I-II trial

Keytruda and Xeloda for Advanced Breast Cancer

Phase II Study of Pembrolizumab and Capecitabine for Advanced Triple Negative and Hormone-Refractory Breast Cancer (NCT03044730)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. Your tumor must be triple negative (ER-/PR-/HER2-) or have progressed on or not responded to an anti-estrogen drug. This study is looking at the safety and effectiveness of using a combination of immunotherapy and chemotherapy to treat triple negative breast cancer. The immunotherapy is pembrolizumab (Keytruda®), which is approved to treat certain types of cancers, but not breast cancer. Capecitabine (Xeloda®) is the chemotherapy used in this study. It is approved to treat advanced breast cancer.
This is a Phase II trial

Atezolizumab & Chemotherapy Before Surgery for Stage II-III Triple Negative Breast Cancer

A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer (NCT03197935)

Summary

To take part in this study, you must have been diagnosed with triple negative (ER-/PR-/HER2-) early stage (stage I-III) breast cancer and not yet started treatment. This study is comparing the safety and effects (good and bad) of using immunotherapy and chemotherapy to chemotherapy alone in triple negative breast cancer. The immunotherapy being used in this study is atezolizumab (Tecentriq®). It stimulates the body's immune system to go after cancer cells. The chemotherapy drugs being used in this study are nab-paclitaxel (Abraxane®) and AC chemotherapy (doxorubicin/Adriamycin® and cyclophosphamide/Cytoxan®). All three drugs are commonly used to treat breast cancer. Patients enrolled in this study will also receive filgrastim or pegfilgrastim to prevent neutropenia--a very low white blood cell count--from developing.
This is a Phase III trial

Keytruda plus Taxol for Metastatic HER2-Negative Breast Cancer

LCI-BRE-H2N-PEPP-001: A Pilot Study of Paclitaxel Plus Pembrolizumab in Patients With Metastatic HER2-Negative Breast Cancer (The PePPy Trial) (NCT03018080)

Summary

To take part in this study, you must have HER2-negative metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good and bad) of using the chemotherapy drug paclitaxel (Taxol®) along with the immunotherapy pembrolizumab (Keytruda®) to treat metastatic HER2-negative breast cancer. The researchers are studying two different treatment regimens. In one regimen, patients will receive Taxol followed by Taxol and Keytruda at the same time. In the other, patients will receive Taxol and Keytruda at the same time. Taxol is routinely used to treat breast cancer. Keytruda is approved to treat certain types of cancers.
This is a Phase II trial

A New Treatment Vaccine for HER2-Low-Expressing Advanced Breast Cancer

Phase I Study of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) in Subjects With Unresectable Locally Advanced or Metastatic HER2-Low-Expressing (IHC 1+/2+) Breast Cancer(NCT02751528)

Summary

To take part in this study, you must have been diagnosed with HER2-low-expressing, advanced (some stage III) or stage IV breast cancer. Your tumor is considered HER2-low-expressing if the results of your IHC test were 1+ (negative) or 2+ (borderline). Note: Not all tumors are tested with an IHC test. This study is investigating how HER2-low expressing tumors respond to a new HER2 treatment vaccine. The vaccine being used in this study is called ETBX-021.
This is a Phase I trial

A Vaccine to Treat HER2+ Advanced Breast Cancer

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

Summary

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

Keytruda plus Enobosarm for Metastatic Triple Negative Androgen Receptor-Positive Disease

A Phase 2 Clinical Trial of the Combination of Pembrolizumab and Selective Androgen Receptor Modulator (SARM) GTX-024 in Patients With Advanced Androgen Receptor (AR) Positive Triple Negative Breast Cancer (TNBC) (NCT02971761)

Summary

To take part in this study, you must have metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. Your tumor must also be androgen receptor positive (AR+). The researchers will test your tumor for these receptors. This study is looking at the safety and effects (good and bad) of giving an anti-androgen drug along with an immunotherapy drug. The anti-androgen drug is enobosarm (Ostarine®/GTx-024). The immunotherapy drug is pembrolizumab (Keytruda®). It is approved to treat certain types of melanoma, lung, head and neck cancers, and blood cancers.
This is a Phase II trial

A Vaccine for Treating HER2-Negative Advanced Breast Cancer

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

Summary

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

Keytruda for Metastatic Inflammatory Breast Cancer

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

Summary

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

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

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

Summary

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

T Cell Immunotherapy for Advanced Breast (and Other) Cancer

Phase I/II Study of the Treatment of Metastatic Cancer That Expresses MAGE-A3 Using Lymphodepleting Conditioning Followed by Infusion of HLA-DP0401/0402 Restricted Anti-MAGE-A3 TCR-Gene Engineered Lymphocytes and Aldesleukin(NCT02111850)

Summary

To take part in this study, you must have metastatic (stage IV) breast cancer and have received a treatment that your tumor progressed on or did not respond to. In addition, your immune cells must express a molecule called HLA-DP4 and your tumor must express a protein called MAGE-A3. This study will allow researchers to learn about the safety, effects (good and bad), and best dose of a new type of immunotherapy called anti-MAGE-A3. T cells are white blood cells that have the ability to kill cancer cells. For this treatment, T cells are removed from your body, modified to fight cancer cells using anti-MAGE-A3, and then infused back into your body. Aldesleukin is a type of immune function enhancing drug that is given along with the infused T cells.
This is a Phase II trial

Keytruda plus an Anti-Estrogen Drug for HR+ Inflammatory Breast Cancer

A Phase II Study of Anti-PD-1 (Pembrolizumab) in Combination With Hormonal Therapy in Patients With Hormone Receptor (HR)-Positive Localized Inflammatory Breast Cancer (IBC) Who Did Not Achieve a Pathological Complete Response (pCR) to Neoadjuvant Chemotherapy (NCT02971748)

Summary

To take part in this study, you must have hormone-sensitive (ER+/PR+) inflammatory breast cancer. In addition, your tumor must have not completely responded to the chemotherapy you received before surgery. This study is looking at whether it is safe and effective to treat patients with inflammatory breast cancer with an immunotherapy drug along with a standard anti-estrogen drug. The immunotherapy drug being used in this study is pembrolizumab (Keytruda®). Your doctor will choose which anti-estrogen drug you receive: tamoxifen/Nolvadex®, exemestane/Aromasin®, anastorzole/Arimidex®, or letrozole/Femara®. If you are premenopausal, you may also receive an LHRH (lutenizing hormone-releasing hormone) agonist.
This is a Phase II trial

CAR-T Cell Immunotherapy for Metastatic Breast Cancer that Spread to the Liver

Phase Ib Trial of CAR-T Hepatic Artery Infusions Delivered With the Surefire Infusion System (SIS) for CEA-Expressing Liver Metastases (NCT02850536)

Summary

To take part in this study, you must have metastatic (stage IV) breast cancer that has spread to your liver. You must have also have already had at least one chemotherapy that your cancer progressed on or did not respond to. This study will determine the safety and effects (good and bad) of using a type of immunotherapy called CAR-T cell therapy to treat cancer that has spread to the liver. The first step of CAR-T cell therapy is to have white blood cells removed. These cells then go through a special laboratory so that they emerge with chimeric antigen receptors (CARs) that are able to identify cancer cells. Then, the white blood cells are put back in your body to fight your cancer. You will also receive a low-dose immune function enhancing drug called IL-2. This study is also recruiting patients with liver metastases from other types of cancer.
This is a Phase I trial

Veliparib and/or Tecentriq for BRCA+, Stage III-IV Triple Negative Breast Cancer

A Phase II Multiple-Arm, Open-Label, Randomized Study of PARP Inhibition (Veliparib; ABT-888) and Anti-PD-L1 Therapy (Atezolizumab; MPDL3280A) Either Alone or in Combination in Homologous DNA Repair (HDR) Deficient Triple Negative Breast Cancer (TNBC) (NCT02849496)

Summary

To take part in this study, you must have stage III or IV triple negative (ER-/PR-/HER2-) breast cancer. You must also test positive for the inherited BRCA1/2 mutation. This study is investigating how well two different types of cancer drugs work when they are used alone or together to treat stage III or IV triple negative breast cancer. The two drugs being used in this study are Veliparib (ABT-888) and atezolizumab (Tecentriq). Veliparib (ABT-888) is a new type of targeted drug called a PARP inhibitor. It is available only in clinical trials. Tecentriq is a new immunotherapy drug. It is approved to treat bladder cancer and a type of lung cancer.
This is a Phase II trial

Reversing Hormone Therapy Resistance in Metastatic Breast Cancer

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

Summary

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

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

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

Summary

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

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

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

Summary

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

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

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

Summary

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

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

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

Summary

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

TAK-659 plus Nivolumab for Metastatic Triple Negative Breast Cancer

A Phase 1b Study to Evaluate TAK-659 in Combination With Nivolumab in Patients With Advanced Solid Tumors (NCT02834247)

Summary

To take part in this study, you must have triple-negative metastatic breast cancer. This study will treat patients with TAK-659 and nivolumab. TAK-659 is a new cancer drug. It only is available in clinical trials. Nivolumab (Opdivo®) is an immunotherapy drug. It helps your immune system find and attack cancer cells. It is used to treat certain types of metastatic cancer. This study will help the researchers determine the best dose of TAK-659 to give with Opdivo.
This is a Phase I trial

A Tumor Associated Antigen Vaccine for Advanced Breast and Other Cancers

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

Summary

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

Hypofractionated Radiation Therapy with MEDI4736 & Tremelimumab for Metastatic Cancer

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

Summary

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

Combination Immunotherapy in HER2-Negative Metastatic Breast Cancer

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

Summary

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

Opdivo and Darzalex for Advanced Breast (and Other) Cancer

Phase 1/2 Study to Evaluate the Safety and Preliminary Efficacy of Nivolumab Combined With Daratumumab in Participants With Advanced or Metastatic Solid Tumors (NCT03098550)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effectiveness of using two immunotherapy drugs for treating advanced breast cancer. The two drugs being used in this study are nivolumab (Opdivo®) and daratumumab (Darzalex®). Opdivo is approved for treating certain types of melanoma and lung cancer. Darzalex is approved for treating multiple myeloma, a type of blood cancer. This study is also enrolling patients with other types of cancer.
This is a Phase I-II trial

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

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

Summary

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

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

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

Summary

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

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

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

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

Summary

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

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

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

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

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

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

Summary

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

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

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

Summary

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

Immunotherapy for Metastatic Triple Negative Breast (and Other) Cancers

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

Summary

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

FAZ053 and PDR001 for Advanced Triple Negative Breast Cancer

A Phase I, Open-label, Multi-center Dose Escalation Study of FAZ053 as Single Agent and in Combination With PDR001 in Adult Patients With Advanced Malignancies (NCT02936102)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. Also, your cancer must have progressed on a prior treatment or you must have no standard treatments available. This study is looking at whether a new immunotherapy drug is safe and effective when given alone or with another immunotherapy drug currently in clinical trials. The new immunotherapy drug is called FAZ053. This is the first clinical trial to study FAZ053 in cancer patients. The other immunotherapy drug is called PDR001. This study is also enrolling patients with other types of cancer.
This is a Phase I trial

Vaccine Therapy to Prevent Recurrence in Breast Cancer Survivors

A Phase I Trial of the Safety and Immunogenicity of a DNA Plasmid Based Vaccine (WOKVAC) Encoding Epitopes Derived From Three Breast Cancer Antigens (IGFBP-2, HER2, and IGF-IR) in Patients With Breast Cancer (NCT02780401)

Summary

To take part in this study, you must have had a breast tumor that was HER2-negative and that had spread to your lymph nodes. You must also have completed chemotherapy, radiation and/or treatment with a targeted drug within the last 28 days. This study is investigating the safety of a new DNA vaccine researchers have developed that may reduce the risk of a breast cancer recurrence. The vaccine, called WOKVAC, is designed to get the immune system to see and go after cancer cells. The vaccine is available only in a clinical trial.
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

Immunotherapy Combination for Advanced Triple Negative Breast Cancer

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

Summary

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

Keytruda with Taxol or Xeloda for Advanced Triple Negative Breast Cancer

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

Summary

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

Keytruda with Chemotherapy for Metastatic Triple Negative Breast Cancer

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

Summary

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

Keytruda After Neoadjuvant Chemo & Surgery for Stage I-III Triple-Negative Breast Cancer

A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With ≥ 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy (NCT02954874)

Summary

To take part in this study, you must have stage I-III triple negative (ER-/PR-/HER2-) breast cancer. You must also have received chemotherapy before surgery—called neoadjuvant treatment—and still have part of the tumor in your breast and/or have been told cancer cells were found in your lymph nodes. This study is investigating whether an immunotherapy drug may be effective for treating triple negative breast cancer. The immunotherapy drug being used in this study is pembrolizumab (Keytruda®). It is approved to treat a certain type of metastatic lung cancer.
This is a Phase III trial

Combination Immunotherapy for Metastatic Triple Negative Breast Cancer

A Multicenter, Open-label, Phase 2 Study of Imprime PGG and Pembrolizumab in Subjects With Advanced Melanoma Failing Front-line Treatment With Checkpoint Inhibitors (CPI) or Triple Negative Breast Cancer (TNBC) Failing Front-line Chemotherapy for Metastatic Disease (NCT02981303)

Summary

To take part in this study, you must have metastatic triple-negative (ER-/PR-/HER2-) breast cancer. In addition, you must have had at least one chemotherapy drug to treat your metastatic breast cancer. Researchers are studying whether it is safe and effective to use two immunotherapy drugs that work in different ways to treat metastatic triple-negative breast cancer. The two drugs being used in this study are Imprime PGG and pembrolizumab (Keytruda®). Imprime PGG is an experimental drug that is only available in clinical trials. Keytruda is approved to treat advanced melanoma (skin cancer) and certain types of lung and head and neck cancers. Its use in breast cancer is considered experimental.
This is a Phase II trial

Using Two Immunotherapy Drugs to Treat Metastatic Triple Negative Breast Cancer

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

Summary

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

Mesothelin-Targeted T Cell Immunotherapy for Metastatic Breast Cancer

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

Summary

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

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

Immunotherapy (PDR001) With a Targeted Therapy for Advanced Triple Negative Breast Cancer

Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacodynamics (PD) of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)(NCT02900664)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer and have already had at least one prior treatment that your cancer progressed on or did not respond to. Researchers are studying the safety and effects (good or bad) of a new immunotherapy drug when it is given along with a targeted drug for treating advanced or metastatic triple negative breast cancer. If you enroll in this study will receive the immunotherapy drug PDR001. You will also receive one of four targeted drugs: Canakinumab (Ilaris®), CJM112, trametinib, or EGF816. This study is also enrolling patients with other types of cancer.
This is a Phase I trial

Keytruda and Radiation Therapy for Early Stage Triple Negative Breast Cancer

Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer With and Without Intra-operative RT: a Window of Opportunity Study (NCT02977468)

Summary

To take part in this study, you must have recently been diagnosed with early stage (stage I-III) triple negative (ER-/PR-/HER2-) breast cancer and not have received any treatment--chemotherapy, radiation or surgery--for your cancer. Giving a drug before surgery allows doctors to study the effect the drug has on cancer cells. This study is looking at the effect that the immunotherapy drug pembrolizumab (Keytruda®) has on triple negative cancer cells. The researchers will also study the effect radiation giving during surgery has on breast cancer cells treated with immunotherapy. Keytruda is approved to treat certain types of lung, head and neck and blood cancers. The radiation treatment, called intraoperative radiation therapy (IORT), delivers a high dose of radiation to the area where the tumor was removed.
This is a Phase I trial

Two Immunotherapies for Treating Advanced Breast Cancer

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

Summary

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

A Study of ABBV-181 in Participants With Advanced Solid Tumors

A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-181, a Monoclonal Antibody , in Subjects With Advanced Solid Tumors (NCT03000257)

Summary

To take part in this study, you must have metastatic (stage IV) or locally advanced (some types of stage III) breast cancer that cannot be removed by surgery. This study is looking at whether a new type of immunotherapy drug is safe and effective in patients with metastatic or locally advanced breast cancer. The study will also determine the best dose of the drug to use. The drug is called ABBV-181. It is only available in clinical trials. This study is also enrolling patients with other types of advanced cancer. This study has two parts. If you are in the first part, called the dose escalation phase, you can take part if you have already been treated with PD-1/PD-L1 immunotherapy drugs. If you are in the second part, called the dose expansion phase, you cannot have had any PD-1/PD-L1 immunotherapy drugs.
This is a Phase I trial

Keytruda for Advanced BRCA+ Breast Cancer

Open Label, Phase II Pilot Study of Immune Checkpoint Inhibition With Pembrolizumab in Advanced BRCA-mutated Breast Cancers (NCT03025035)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer and have been tested and told that you have the inherited BRCA (BRCA1 or BRCA2) mutation. This study is looking at the safety and effect of using the immunotherapy drug pembrolizumab (Keytruda®) to treat advanced or metastatic breast cancer in patients with a BRCA mutation.
This is a Phase II trial

An Immunotherapy Drug for Advanced Breast (and Other) Cancers

A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, in Patients With Advanced Solid Malignancies and Lymphoma With an Expansion in Select Malignancies (NCT02922764)

Summary

To take part in this study, you must have certain types of stage III breast cancer or stage IV (metastatic) breast cancer. You must also have already tried the standard treatments for your cancer. This study is investigating whether a new immunotherapy drug is safe and effective for treating advanced breast cancer. The immunotherapy drug being studied is called RGX-104. It is only available in clinical trials. Patients with other types of advanced cancer also will be enrolled in this trial.
This is a Phase I trial

BriaVax™ in Metastatic or Locally Recurrent Breast Cancer

A Phase I/IIa Study of the Whole-Cell Vaccine BriaVax™ in Metastatic or Locally Recurrent Breast Cancer Patients (NCT03066947)

Summary

To take part in this study, you must have locally recurrent (some stage III) or metastatic (stage IV) breast cancer. You must also NOT be currently receiving any therapy (chemotherapy, immunotherapy, surgery and/or radiation). This study is investigating the safety and effects (good and bad) of an experimental immunotherapy called BriaVax™ when it is given with cyclophosphamide (Cytoxan®) to women with advanced breast cancer. Interferon-alpha-2b is given after the BriaVax vaccine to boost the immune system.
This is a Phase I-II trial

CX-2009 Immunotherapy for Advanced Breast (and Other) Cancer

A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009) (NCT03149549)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. This study in investigating the safety and effects (good and bad) of a new immunotherapy for treating advanced breast cancer. CX-2009 is the immunotherapy being used in this study. This trial is also enrolling patients with other types of solid tumors.
This is a Phase I-II trial

Vaccine and Immunotherapies for Treating Advanced Breast (and Other) Cancer

A Basket Study: NY-ESO-1 TCR Engineered Adoptive Cell Transfer Therapy With CTLA4 Blockade (NCT02070406)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have had a treatment that your cancer progressed on or did not respond to. This study will help researchers learn about safety, effects (good and bad), and best dose of the immunotherapy ipilimumab (Yervoy®) to be given with modified T-cells, and a dendritic cell vaccine. Yervoy is approved to treat melanoma. T cells are immune cell that have the ability to kill cancer cells. Modified T cells are T cells that have been removed from your body and put through a special laboratory procedure that teaches them to see specific proteins found on cancer cells. Dendritic cells are a different type of immune cell. They are used in cancer treatment vaccines. You will also receive a low-dose immune function enhancing drug called IL-2.
This is a Phase I trial

Using Three Immunotherapy Treatments for Advanced Breast Cancer

A Phase 1/2 Study of In Situ Vaccination With Tremelimumab and IV Durvalumab (MEDI4736) Plus the Toll-like Receptor Agonist PolyICLC in Subjects With Advanced, Measurable, Biopsy-accessible Cancers (NCT02643303)

Summary

To take part in this study, you must have locally recurrent advanced (some stage III) breast cancer. This study is evaluating the safety and effects (good and bad) of using three different types of immunotherapy treatments in advanced and metastatic breast cancer. The treatments being used in this study are tremelimumab, durvalumab (MEDI4736) and poly ICLC. This study is also recruiting individuals with other types of advanced cancer.
This is a Phase I-II trial

CAR-T NKR-2 for Metastatic Triple Negative Breast Cancer

A Multi-national, Open-label, Dose Escalation Phase I Study to Assess the Safety and Clinical Activity of Multiple Administrations of NKR-2 in Patients With Different Metastatic Tumor Types (THINK - THerapeutic Immunotherapy With NKR-2) (NCT03018405)

Summary

To take part in this study, you must have metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. This study is looking at whether a new type of immunotherapy is safe and effective for treating metastatic tumors. CAR-T NKR-2 is the immunotherapy used in this study. This study is also enrolling patients with other types of cancer.
This is a Phase I trial

SGN-2FF Immunotherapy for Advanced Breast (and Other) Cancer

A Phase 1, Multicenter, Open-label, Dose-escalation Study of SGN-2FF in Patients With Advanced Solid Tumors (NCT02952989)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have already received a treatment that your cancer progressed on or did not respond to. This study will determine the safety, effect, and best dose of a new type of immunotherapy. The drug being used in this study is called SGN-2FF. This study is also recruiting patients with other types of cancer.
This is a Phase I trial

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

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

Summary

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

Immunotherapy Plus a Targeted Drug for Advanced Triple Negative Breast Cancer

Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacodynamics (PD) of PDR001 in Combination With LCL161, Everolimus (RAD001) or Panobinostat (LBH589) (NCT02890069)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. You must also have already received a treatment that your cancer progressed on or did not respond to. This study is looking at whether a new immunotherapy dug is safe and effective when given along with a targeted drug to patients with advanced or metastatic triple negative breast cancer. The immunotherapy drug used in this study is called PDR001. You will receive one of three targeted drugs: LCL161, everolimus (Afinitor®), or panobinostat (LBH589). This study is also enrolling patients with other types of cancer.
This is a Phase I trial

Keytruda plus Radiation Therapy for HR+, HER2- Metastatic Breast Cancer

A Phase II Study Of Pembrolizumab In Combination With Palliative Radiotherapy For Metastatic Hormone Receptor Positive Breast Cancer (NCT03051672)

Summary

To take part in this study, you must have HR-positive (ER+/PR+), HER2-negative, metastatic breast cancer. This study will evaluate the safety and effects (good and bad) of using immunotherapy and radiation therapy together to treat metastatic breast cancer. Pembrolizumab (Keytruda®) is the immunotherapy used in this study. Keytruda is approved to treat metastatic melanoma and certain types of lung, head and neck, and blood cancers.
This is a Phase II trial

Two Immunotherapy Drugs for Advanced Breast Cancer

A Basket Study: A Phase Ib Open-Label, Dose-Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination With M9241(NHS-IL12) in Subjects With Locally Advanced, Unresectable, or Metastatic Solid Tumors (COMBO) (NCT02994953)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety, side effects and best dose of the immunotherapy drug NHS-IL12 when it is given in combination with the immunotherapy drug avelumab. NHS-IL12 is an investigational drug. Avelumab (Bavencio) is currently approved for treating certain types of cancers.
This is a Phase I trial

INCAGN01876 plus Immunotherapies in Advanced Triple Negative Breast (and Other) Cancer

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies (NCT03126110)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. This study will allow researchers to learn about the safety and effect (good and bad) of giving a new immunotherapy along with one or two approved immunotherapy drugs. The new immunotherapy drug is called INCAGN01876. The two FDA-approved immunotherapy drugs are nivolumab (Opdivo®) and ipilimumab (Yervoy®). These drugs are approved to treat certain types of cancers, but not breast cancer. This study is also recruiting patients with other types of advanced or metastatic solid tumors. Only phase I of this study is open to triple negative breast cancer patients.
This is a Phase I-II trial

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

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

Summary

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

Vaccine Therapy for HER2+ Metastatic Breast Cancer

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

Summary

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

BGB324 with Keytruda for Inflammatory or Advanced Triple Negative Breast Cancer

A Phase II, Multi Centre Study of BGB324 in Combination With Pembrolizumab in Patients With Previously Treated, Locally Advanced and Unresectable or Metastatic Triple Negative Breast Cancer (TNBC) or Triple Negative Inflammatory Breast Cancer (TN-IBC) (NCT03184558)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) inflammatory (some stage III or IV) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good and bad) of using a targeted drug along with an immunotherapy to treat triple negative inflammatory or metastatic breast cancer. The targeted drug being used in this study is called BGB32. It is a new type of targeted drug called an AXL inhibitor. The immunotherapy being used in this study is the PD-1 inhibitor pembrolizumab (Keytruda®).
This is a Phase II trial

Using Extreme Cold & Immunotherapy to Kill Cancer Cells Before Surgery

A Pilot Study of Pre-Operative, Single-Dose Ipilimumab, Nivolumab and Cryoablation in Early Stage/Resectable Breast Cancer(NCT02833233)

Summary

To take part in this study, you must have recently been diagnosed with early-stage breast cancer, have a tumor that is at least 1.5 cm or larger, and be scheduled to have surgery. Researchers think using extreme cold along with two immunotherapy drugs will make a breast tumor get smaller before surgery. Using extreme cold to kill cancer cells is called cryoablation. During the first part of the procedure, a very thin piece of metal, called a probe, is inserted into the tumor. During the second part, the probe is cooled to an extremely low temperature. This freezes and then kills cancer cells. Immunotherapy drugs help the immune system kill cancer cells. The two immunotherapy drugs used in this study are ipilimumab (Yervoy®) and nivolumab (Opdivo®).

Keytruda, Femara & Ibrance for ER+ Metastatic Breast Cancer After Femara & Ibrance

Phase II Study of the Addition of MK-3475 (Pembrolizumab) to Letrozole and Palbociclib in Patients With Metastatic Estrogen Receptor Positive Breast Cancer Who Have Stable Disease But Are Not Responding to Letrozole and Palbociclib (NCT02778685)

Summary

To take part in this study, you must have estrogen receptor-positive (ER+), HER2-negative, metastatic breast cancer. You must have also already been treated with letrozole (Femara®) and palbociclib (Ibrance®). Femara and Ibrance are an approved breast cancer combination. Femara is an anti-estrogen drug. Ibrance is a targeted treatment. Researchers think adding an immunotherapy drug to this combination will make the combination work better in women who already tried it. The immunotherapy drug that will be used in this study is pembrolizumab (Keytruda®). Keytruda is used to treat certain types of melanoma, lung cancer and head and neck cancers. It is available as a breast cancer treatment only in clinical trials.
This is a Phase II trial

A Vaccine and Durvalumab After Surgery for Stage II or III Triple Negative Breast Cancer

A Phase 1b Study of Safety and Immune Response to PVX-410 Vaccine Alone and in Combination With Durvalumab in Human Leukocyte Antigen (HLA)-A2+ Subjects Following Standard Treatment of Stage II or III Triple Negative Breast Cancer (NCT02826434)

Summary

To take part in this study, you must have been diagnosed with stage II or III triple negative (ER-/PR-/HER2-) breast cancer and have already received the standard treatment for your tumor's stage. This study is looking at whether it is safe and effective to combine two different types of immunotherapy--a vaccine and a targeted drug. The vaccine being studied is called PVX-410. It is only available in clinical trials. The targeted drug is durvalumab. It is being studied in clinical trials for breast and other types of cancer. It blocks a protein called PD-L1 (programmed cell death ligand-1).
This is a Phase I trial

MCS110 and PDR001 For Advanced Triple Negative Breast (and Other) Cancer

A Phase Ib/II, Open Label, Multicenter Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies (NCT02807844)

Summary

To take part in this study, you must have advanced triple negative breast cancer and have already been treated with standard treatments or have no standard treatment available. This study is investigating whether it is safe and effective to combine two cancer drugs that work in different ways. The researchers also want to learn more about how these two drugs work together. The two drugs being used in this study are MCS110 and PDR001. MCS110 is a targeted treatment. PDR001 is an immunotherapy drug. Both of these drugs are currently only available in clinical trials. This study is also enrolling patients with advanced pancreatic and endometrial cancers and advanced melanoma (skin cancer).
This is a Phase I-II trial

CAR-T Cell Immunotherapy for Triple Negative Breast Cancer

Clinical Trial of Autologous cMET Redirected T Cells Administered Intravenously in Patients With Melanoma & Breast Carcinoma (NCT03060356)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. This study is evaluating the safety and effectiveness of using a type of immunotherapy called CAR T-cell therapy to treat advanced and metastatic breast cancer. In CAR T-cell therapy, your white blood cells are genetically engineered to produce chimeric antigen receptors (CARs) that can identify cancer cells. This study is also enrolling patients with advanced melanoma.

LY3022855 for Advanced Breast (and Prostate) Cancer

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

Summary

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

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

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

Summary

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

Immunotherapy for Early-Stage Breast Cancer Patients at High Risk for Recurrence

A Study of hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse Post Definitive Surgery and Standard Therapy (NCT02960594)

Summary

To take part in this study, you must have had surgery and standard treatment for stage I, II, or III breast cancer and currently have no evidence of disease. This study is investigating whether giving patients who have completed cancer treatment an immunotherapy drug will keep their cancer from coming back. The two immunotherapy drugs being used in this study are called INO-1400 and INO-9012. They are both given by injection. After the injection, patients receive electroporation, a pulse of electricity that creates an opening in the cell membranes so the immunotherapy drug can get inside the cell. This study is also enrolling individuals with other solid tumors.
This is a Phase I trial

Atezolizumab and Entinostat for Advanced Triple Negative Breast Cancer

A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 2 Study of Atezolizumab With or Without Entinostat in Patients With Advanced Triple Negative Breast Cancer, With a Phase 1b Lead in Phase (NCT02708680)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have already been treated with one or two anti-cancer drugs that your cancer progressed on or did not respond to. This study is looking at whether giving advanced breast cancer patients an immunotherapy drug and a targeted drug at the same time is a safe and effective treatment. The immunotherapy drug is atezolizumab (Tecentriq®). It is approved to treat certain types of lung cancer and bladder cancer. The targeted drug is entinostat. It blocks an enzyme called HDAC. It is only available in clinical trials.
This is a Phase I-II trial

Abemaciclib and Keytruda for HR+, HER2- Metastatic Breast (and Non-Small Cell Lung) Cancer

A Phase 2 Study of Abemaciclib in Combination With Pembrolizumab for Patients With Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer (NCT02779751)

Summary

To take part in this study, you must have hormone sensitive (ER+/PR+), HER2-negative metastatic (stage IV) breast cancer. This study is investigating whether it is safe and effective to give a new type of targeted treatment along with an immunotherapy drug. The new targeted treatment is called abemaciclib (LY2835219). It is a type of targeted drug called a CDK 4/6 inhibitor. It only is available in clinical trials. Pembrolizumab (Keytruda®) is the immunotherapy drug being used in this study. Keytruda is approved to treat melanoma and non-small cell lung cancer. Its use in breast cancer is considered experimental. This study is also recruiting individuals with metastatic non-small cell lung cancer.
This is a Phase I trial

Tecentriq and Kadcyla for HER2+ Advanced Breast Cancer

A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab and Taxane Based Therapy (KATE2) (NCT02924883)

Summary

To take part in this study, you must have HER2-positive advanced (some stage III) or metastatic (stage IV) breast cancer. In addition, you must have already been treated with trastuzumab (Herceptin®) and a taxane-based chemotherapy, either alone or in combination, and/or have progressed within 6 months of completing adjuvant therapy. This study will determine the safety and effectiveness of using an immunotherapy along with a HER2-targeted drug to treat advanced HER2-positive breast cancer. Atezolizumab (Tecentriq®) is the immunotherapy used in this study. It is approved to treat certain types of lung cancer and bladder cancer. Trastuzumab emtansine/T-DM1 (Kadcyla®) is a HER2-targeted drug used to treat metastatic breast cancer.
This is a Phase II trial

Keytruda plus Kadcyla for HER2+ Metastatic Breast Cancer

A Phase 1b Study Of Pembrolizumab In Combination With Trastuzumab-DM1 In Metastatic HER2-Positive Breast Cancer (NCT03032107)

Summary

To take part in this study, you must have HER2-positive metastatic (stage IV) breast cancer. This study is investigating the safety, best dose and what effects (good or bad) occur when HER2+ metastatic breast cancer is treated with an immunotherapy and a HER2-targeted drug. The immunotherapy being used in this study is the PD-1 inhibitor pertuzumab (Keytruda®). It is approved to treat certain types of melanoma, lung cancer and head and neck cancer. The HER2-targeted drug is T-DM1 (Kadcyla®), which combines the chemotherapy drug DM1 and the HER2-targeted drug trastuzumab (Herceptin®). It is used to treat HER2+ metastatic breast cancer.
This is a Phase I trial