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A Phase 1 Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced Malignancies (NCT03629756)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) breast cancer.

This study will evaluate the safety and effects (good and bad) of AB928 when it is used in combination with AB122. AB928 is an investigational immunotherapy drug. It is designed to prevent tumor cells from inhibiting immune cells. AB122 is an investigational type of immunotherapy called a PD-1 inhibitor. By blocking PD-1, it helps the immune system see and go after cancer cells. This study will also enroll patients with other types of advanced cancer.

A Phase 1 Study to Evaluate the Safety and Tolerability of AB154 Monotherapy and Combination Therapy in Participants With Advanced Malignancies(NCT03628677)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) breast cancer that can not be treated with any standard therapies.

This study is comparing the safety and effects (good or bad) of using the immunotherapy drug AB154 alone with using it in combination with the immunotherapy drug AB122. AB154 is an investigational drug that stimulates the immune system by blocking a checkpoint called TIGIT. AB122 is an investigational immunotherapy that gets the immune system to go after cancer cells by blocking PD-1. This study is also enrolling patients with other types of cancers.

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-033, an Anti-LAG-3 Monoclonal Antibody, Alone and in Combination With an Anti-PD-1 in Patients With Advanced Solid Tumors (NCT03250832)

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. There are two parts to this study. In part I, researchers will determine the best dose of the immunotherapy TSR-033. In part II, researchers will compare the safety and effects (good and bad) of TSR-033 when it is given with an immunotherapy that blocks PD-1. TSR-033 is an experimental immunotherapy that blocks the protein LAG-3.This study is also recruiting patients with other types of cancer.

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.

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.

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.

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.

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.

A Phase I/II Open-label Study of EDP1503 Alone and in Combination With Pembrolizumab in Patients With Advanced Metastatic Colorectal Carcinoma, Triple-negative Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors (NCT03775850)

Summary

To take part in this study you must be a woman or man with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) and have no other approved treatment options available.

This study is assessing the safety and the effects (good or bad) of the immunotherapy EDP1503 when it is given along with pembrolizumab (Keytruda®). EDP1503 is an experimental immunotherapy that may work by changing the microenvironment that surrounds the cancer cells. Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is only approved to treat certain types of cancers. Its use in breast cancer is considered experimental.

A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-262 in Combination With NKTR-214 and in Combination With NKTR-214 Plus Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumor Malignancies (REVEAL) (NCT03435640)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer. In this study, researchers will evaluate the safety and best dose of two experimental immunotherapy drugs when they are given with or without the immunotherapy drug nivolumab (Opdivo®) to treat advanced breast cancer. NKTR-262 and NKTR-214 are the experimental immunotherapy drugs being used in this study. Opdivo is a type of immunotherapy drug called a PD-1 inhibitor. It is approved to treat certain types of metastatic melanoma and non-small cell lung cancer.

FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors (Phase 1) (NCT03841110)

Summary

To take part in this study, you must have HER2-positive advanced (some stage III) or metastatic (stage IV) breast cancer and have had your cancer progress after being treated with nivolumab (Opdivo®), pembrolizumab (Keytruda®) or atezolizumab (Tecentriq®).

This study is evaluating the safety and effects (good or bad) of giving FT500 alone or with immunotherapy. FT500 is a natural killer (NK) cell immunotherapy. NK cells are specialized immune cells that can fight cancer cells. Cyclophosphamide and fludarabine are chemotherapy drugs used to deplete lymph cells. Opdivo, Tecentriq and Keytruda are each a type of immunotherapy drug called a PD-1 (programmed cell death-1) inhibitor. They are approved to treat certain other types of cancers, but their use in breast cancer is considered experimental. This study is also enrolling patients with other types of cancers.

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.

FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors (DIMENSION) (NCT03319459)

Summary

To take part in this study, you must have HER2-positive, advanced (some stage III) or metastatic (stage IV) breast cancer. This study is looking at the safety and effects (good or bad) of using an immunotherapy drug along with Herceptin to treat HER2-positive advanced breast cancer. The immunotherapy drug is called FATE-NK100. It is only available in clinical trials. Herceptin is a targeted therapy approved to treat HER2-positive breast cancer.

A Basket Trial of Pembrolizumab in Patients With Advanced Solid Tumors and Genomic Instability (NCT03428802)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer and have been tested for and found to have a BRCA1 or BRCA2 mutation. This study is investigating the effect of using an immunotherapy drug to treat cancer that has spread outside the breast to nearby tissue or lymph nodes or to other parts of the body. The immunotherapy drug is pembrolizumab (Keytruda®). It is a type of immunotherapy drug called a PD-1 inhibitor. It gets the 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 ly

A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-214 and Nivolumab in Patients With Select Locally Advanced or Metastatic Solid Tumor Malignancies (PIVOT) (NCT02983045)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the best dose, safety and effects (good and bad) of using an investigational immunotherapy along with the immunotherapy drug Nivolumab (Opdivo®) to treat advanced or metastatic triple negative breast cancer. The investigational therapy NKTR-214 targets a protein found on immune cells called CD-122. Targeting the protein gets the immune system to go after cancer cells. Opdivo®) is a type of immunotherapy called a PD-1 (programmed cell death 1) inhibitor. It is approved to treat certain types of cancers, but not breast cancer. Researchers believe using the two immunotherapies together will treat cancer more effectively.

A Phase I/Ib, Open-label, Multi-center Dose Escalation Study of NIS793 in Combination With PDR001 in Adult Patients With Advanced Malignancies (NCT02947165)

Summary

To take part in this study you must have locally advanced (stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) and have no other standard treatment options available.

This study is investigating the safety, effects (good or bad) and best dose of NIS793 when it is used alone or with an immunotherapy. NIS793 is a targeted therapy that binds to the transforming growth factor-beta receptor. Spartalizumab is the investigational immunotherapy being used in this study. It is a type of immunotherapy called a PD-L1 checkpoint inhibitor. This study is also enrolling patients with other types of solid tumors.

A Phase 1 Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of Escalating Doses And Treatment Intensification Of A Vaccine-based Immunotherapy Regimen-2 (Vbir-2) (Pf-06936308) For Advanced Non-small Cell Lung Cancer And Metastatic Triple-negative Breast Cancer (NCT03674827)

Summary

To take part in this study, you must have metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-).

This study will investigate the safety and effects (good or bad) of increasing doses of a vaccine-based immunotherapy called TPF-06936308. The vaccine is designed to make immune cells find and then stop the growth of cancer cells. This study is also enrolling patients with advanced non-small cell lung 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 drug 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.

A Phase 1/2 Study of Galinpepimut-S in Combination With Pembrolizumab (MK 3475) in Patients With Selected Advanced Cancers (NCT03761914)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has not responded to other treatment options.

This study is assessing the safety, effects (good and bad) and best dose of the immunotherapy galinpepimut-S when it is used along with pembrolizumab (Keytruda®). Galinpepimut-S is a vaccine that targets the protein WT1. Higher than normal amounts of this protein are found on the surface of breast and certain other cancer cells. Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.

A Phase 2, Multi-center, Open Label Study of NIR178 in Combination With PDR001 in Patients With Selected Advanced Solid Tumors and Non-Hodgkin Lymphoma (NCT03207867)

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 is investigating the safety and effects (good and bad) of using two different types of immunotherapy drugs at the same time to treat advanced triple negative breast cancer. The two experimental immunotherapies being used in this study are NIR178 and PRD001. NIR178 is an adenosine receptor antagonist. It blocks adenosine, which is found in the microenvironment that surrounds the tumor. PDR001 is a type of immunotherapy called a PD-1 inhibitor. This trial is also enrolling patients with other types of advanced cancers.

A Phase 1b, Multicenter, Two-Part, Open-Label Study of DS-8201a, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer (NCT03523572)

Summary

To take part in this study, you must have HER2 positive or low HER2 expression advanced (some stage III) or metastatic (stage IV) breast cancer that did not respond to standard therapies.

This study will test the safety and effects (good or bad) of an experimental drug called DS-8201 when it is given along with an immunotherapy to treat advanced breast cancer. DS-8201a (Trastuzumab deruxtecan) is a new type of HER2-targeted therapy. It is an antibody-drug conjugate (ADC), which means it uses an antibody to deliver a chemotherapy drug directly to the cancer cells. The immunotherapy being used in this study is the PD-1 inhibitor nivolumab (Opdivo®). By blocking PD-1, it allows your immune system to see and go after cancer cells. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.

Phase II Window of Opportunity Trial of Stereotactic Body Radiation Therapy and In Situ Oncolytic Virus Therapy in Metastatic Triple Negative Breast Cancer and Metastatic Non-Small Cell Lung Cancer Followed by Pembrolizumab (STOMP) (NCT03004183)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-), advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effect (good and bad) of using stereotactic body radiation therapy, a vaccine and an immunotherapy to treat advanced triple negative breast cancer. Stereotactic body radiation therapy (SBRT) delivers a high dose of radiation directly to the tumor. The vaccine is called ADV/HSV-tk. It is given along with the anti-viral drug valacyclovir. The immunotherapy used in this study is pembrolizumab (Keytruda®). It is approved to treat certain types of cancers. This study is also recruiting patients with advanced non-small cell lung cancer.

A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb20717 in Subjects With Selected Advanced Solid Tumors (DUET-2) (NCT03517488)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options.

This study is testing the safety, effects (good and bad) and best dose of an experimental immunotherapy called XmAb20717 that blocks two proteins on immune cells, PD-1 and CTLA4. Blocking these proteins helps your immune system see and go after cancer cells.

A Phase 1 Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02385 in Participants With Select Advanced Malignancies (NCT03538028)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options.

This study will test the safety and effects (good and bad) of a new type of immunotherapy called INCAGN02385. The therapy gets the immune system to see and go after cancer cells by activating a molecule found on T cells called LAG-3. This study is also enrolling patients with other types of cancer.

Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer (NCT03674567)

Summary

To take part in this study, you must be a woman or man with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer.

This study is looking at the best dose, safety and effects (good and bad) of using FLX475 alone or with pembrolizumab (Keytruda®) to treat advanced breast cancer. FLX475 is an investigational targeted therapy that help the immune system go after cancer cells. Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.

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.

A Phase I/Ib, Open-label, Multi-center, Study of NZV930 as a Single Agent and in Combination With PDR001 and/or NIR178 in Patients With Advanced Malignancies.(NCT03549000)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options.

This study is comparing the safety and effects (good or bad) of NZV930 alone or in combination with PDR001 and/or NIR178. NZV930 is an investigational targeted therapy that blocks the CD73 protein. Blocking this protein allows T cells and other immune cells to attack the tumor. PDR001 is an investigational immunotherapy. It is a type of immunotherapy called a PD-1 inhibitor. NIR178 is an investigational immunotherapy. It is an immune checkpoint inhibitor that gets the immune system to attack cancer cells by blocking the adenosine A2A receptor (A2AR).

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

A Phase 2, Open-Label Study of Intratumoral Tavokinogene Telseplasmid Plus Electroporation in Combination With Intravenous Pembrolizumab Therapy in Patients With Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer (NCT03567720)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer.

This clinical trial will study tumor response to and the effects (good or bad) of using Tavo-EP and pembrolizumab (Keytruda®) together to treat advanced breast cancer. Keytruda is a type of immunotherapy called a PD-1 inhibitor. It stimulates the body's immune system to go after cancer cells. It is approved to treat certain types of cancers, and its use in breast cancer is considered experimental. Tumor infiltrating lymphocytes (TILs) are immune cells that have moved from the blood into a tumor cell. Studies have found that tumors with fewer TILs do not respond as well to immunotherapy. Tavo-EP (Tavo™) activates the immune system in a way that brings more TILs into the tumors. It is administered through electroporation, an electric current that makes it possible to put a drug or DNA into a cell. Researchers think using Tavo with Keytruda will make tumors more likely to respond to Keytruda.

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.

A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Immunotherapy Combinations in Adult Patients With Triple-negative Breast Cancer(NCT03742349)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-); have not received more than two prior lines of chemotherapy, including neoadjuvant or adjuvant chemotherapy; and have had a taxane-based chemotherapy as neoadjuvant or metastatic treatment.

This study will investigate the safety, best dose and effects (good and bad) of spartalizumab and LAG525 when they are used in combination with NIR178, capmatinib, MCS110, or canakinumab. Spartalizumab is an investigational PD-1 immune checkpoint inhibitor. LAG525 is an investigational immune checkpoint inhibitor that targets LAG-3. NIR178 is an investigational immunotherapy. Capmatinib is a targeted therapy that blocks c-Met, which plays a role in cancer cell growth. MCS110 is an investigational immunotherapy that targets M-CSF. Canakinumab is an investigational monoclonal antibody that targets human interleukin-1 beta (IL-1b), which plays a role in inflammation.

A Phase II Open-label, Randomized, Three-arm, Multicenter Study of LAG525 Given in Combination With Spartalizumab (PDR001), or With Spartalizumab and Carboplatin, or With Carboplatin, as First or Second Line Therapy in Patients With Advanced Triple-negative Breast Cancer (NCT03499899)

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 that progressed on one prior taxane-based chemotherapy regimen.

This study will evaluate the best dose, safety and effect (good or bad) of the experimental immunotherapy drug LAG525 when it is used along with another type of experimental immunotherapy and/or chemotherapy. LAG525 gets the immune system to go after cancer cells by blocking a protein called LAG-3. Spartalizumab (PDR001), the other immunotherapy drug used in this study, is an experimental checkpoint inhibitor. The chemotherapy drug being used in this study is carboplatin (Paraplatin®). It is approved to treat triple negative breast cancer.

A Phase 1b/2 Study To Evaluate Safety And Anti Tumor Activity Of Avelumab In Combination With The Poly(Adenosine Diphosphate [Adp]-Ribose) Polymerase (Parp) Inhibitor Talazoparib In Patients With Locally Advanced Or Metastatic Solid Tumors (NCT03330405)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) or HR+, locally advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good or bad) of using an immunotherapy along with a targeted therapy to treat advanced breast cancer. The immunotherapy being used in this study is abelumab (Bavencio®). It works by blocking a protein called PD-L1 (programmed cell death-ligand 1). Talazoparib (BMN-637) is a type of targeted therapy called a PARP inhibitor. It prevents the PARP protein from repairing damaged DNA in tumor cells. This study is also enrolling patients with other types of solid tumors.
This is a Phase II trial

A Phase 1a/1b Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Tumors (NCT03289962)

Summary

To take part in this study, you must have triple negative, locally advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good or bad) of using a personalized cancer vaccine alone or with an immunotherapy to treat advanced breast cancer. The personalized cancer vaccine is called RO7198457. The immunotherapy being used in this study is the PD-L1 inhibitor atezolizumab (Tecentriq®). It works by blocking the PD-L1 (programmed cell death-ligand 1) protein and is approved to treat certain types of bladder and lung cancer. This study is also recruiting patients with other types of solid tumors.

A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®22841 Monotherapy and in Combination With Pembrolizumab in Subjects With Selected Advanced Solid Tumors (DUET-4)(NCT03849469)

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 is investigating the best dose, safety and effects of XmAb22841 when it is used alone or in combination with pembrolizumab (Keytruda®). XmAb22841 is a new type of immunotherapy that targets CTLA-4 and LAG-3. Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is approved to certain types of cancers. Its use in breast cancer is considered experimental. This study is also enrolling patients with other types of cancers.

Innovative Combination Immunotherapy for Metastatic Triple Negative Breast Cancer (TNBC): A Multicenter, Multi-Arm Translational Breast Cancer Research Consortium Study (InCITe) (NCT03971409)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer and have not had more than three lines of chemotherapy and not more than one checkpoint inhibitor.

This study is looking at the safety and effects (good and bad) of combining the immunotherapy drug avelumab (Bavencio®) with binimetinib, utomilumab, or PF-04518600. Bavencio is type of immunotherapy called a PD-L1 inhibitor. It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental. Binimetinib (Mektovi®) is targeted therapy that blocks MEK, which helps cancer cells grow. It is used to treat metastatic melanoma. Its use in breast cancer is considered experimental. PF-04518600 is an investigational immunotherapy that targets OX40, a protein found on immune cells that have interacted with cancer cells. Utomilumab is an investigational immunotherapy that targets the 4-1BB (CD-137) protein on certain immune cells.

A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of KY1044 as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies (NCT03829501)

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 that has not responded to other treatment options.

This study is evaluating the safety and the effects (good or bad) of using KY1044 alone or with Tecentriq® (atezolizumab) to treat advanced breast cancer. KY1044 stimulates immune cells to go after and kill cancer cells. It also kills the T regulatory cells that keep immune cells from killing the cancer cells. Tecentriq® (atezolizumab) is a type of immunotherapy called a PD-L1 (programmed cell death-ligand 1) inhibitor. It is approved to treat advanced triple negative breast cancer, as well as certain types of bladder and lung cancer.

A Dose Escalation and Expansion Study of TRX518 in Combination With Cyclophosphamide Plus Avelumab in Advanced Solid Tumors (NCT03861403)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) breast cancer that is triple negative (ER- PR- HER2-) or be postmenopausal and have advanced or metastatic estrogen receptor positive (ER+) breast cancer. This study is evaluating the safety and effects (good or bad) of giving TRX518, avelumab (Bavencio®), and cyclophosphamide (Cytoxan®) at the same time. TRX518 is an experimental immunotherapy that targets a protein found on immune cells called glucocorticoid-induced TNF-superfamily receptor (GITR). Bavencio is a type of immunotherapy drug called a PD-L1 inhibitor. It is approved to treat some types of cancer. Its use in breast cancer is considered experimental. Cytoxan is a chemotherapy drug used to treat breast cancer. This trial is also enrolling patients with other types of cancer.
This is a Phase I-II trial

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.

A Randomized Phase II Trial of Carboplatin With or Without Nivolumab in First- or Second-line Metastatic Triple-negative Breast Cancer (NCT03414684)

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 is comparing the safety and effects (good and bad) of giving the chemotherapy drug carboplatin (Paraplatin®) alone or with an immunotherapy drug to treat advanced breast cancer. Paraplatin is a chemotherapy drug routinely used to treat advanced breast cancer. The immunotherapy drug used in this study is the PD-1 inhibitor nivolumab (Opdivo®). The drug, which has been approved to treat certain types of cancer, but not breast cancer, stimulates the body's immune system to attack cancer cells by blocking a protein called PD-1 (programmed cell death 1).

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.

A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Breast and Gynecologic Malignancies (NCT03719326)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has progressed on or not responded to available therapies.

This study will evaluate the best dose, safety and effects (good or bad) of AB928 when it is used along with pegylated liposomal doxorubicin (PLD) to treat advanced triple-negative breast cancer. AB928 is a targeted therapy that researchers think can boost the immune system. Pegylated liposomal doxorubicin (Doxil®) is a chemotherapy drug used to treat breast cancer.

A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC (CONTESSA TRIO) (NCT03952325)

Summary

To take part in the first cohort, you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) and have not received prior chemotherapy for advanced disease. To be part of the second cohort, you must be age 65 or older, have advanced or metastatic HER2 negative breast cancer, and have not received prior chemotherapy for advanced disease.

In the first cohort, this study is comparing the safety and effects (good and bad) of an experimental oral chemotherapy drug called tesetaxel when it is given with one of three immunotherapy drugs. In the second cohort, the study is investigating the safety and effects (good and bad) of tesetaxel when it is given alone. The three immunotherapy drugs being used in this study are nivolumab (Opdivo®), pembrolizumab (Keytruda®), and atezolizumab (Tecentriq®). Opdivo and Keytruda are PD-1 inhibitors. They get the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). Both are approved for certain types of cancers. Their use in breast cancer is considered experimental. Tecentriq is a PD-L1 inhibitor. It gets the immune system to go after cancer cells by blocking PD-L1. Tecentriq in combination with Abraxane is an FDA-approved treatment for metastatic triple negative breast cancer.

A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors (NCT03071757)

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 is investigating the safety and best dose of a new immunotherapy, called ABBV-368. In this study patients will receive the drug alone or in combination with the immunotherapy drug nivolumab (Opdivo®). Opdivo is approved to treat certain types of metastatic melanoma and non-small cell lung cancer. It blocks a protein called PD-1.This study is also enrolling patients with other types of cancer.

A Phase III, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Paclitaxel Compared With Placebo With Paclitaxel for Patients With Previously Untreated Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer (NCT03125902)

Summary

To take part in this study, you must have recently been diagnosed with triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer and not yet started treatment. This study is investigating whether a chemotherapy drug works better when it is given along with an immunotherapy. The chemotherapy drug being used in this study is paclitaxel (Taxol®). It is used to treat breast cancer. The immunotherapy drug being used in this study is atezolizumab (Tecentriq®). It is a PD-L1 inhibitor that is currently approved to treat certain types of bladder and lung cancer.

A Phase 1/1b First-In-Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549 Monotherapy and in Combination With Nivolumab in Subjects With Advanced Solid Tumors (NCT02637531)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has been treated with a cytotoxic chemotherapy but not an anti-PD-1 or anti-PD-L1 immunotherapy.

This study is investigating the safety and effects (good and bad) of IPI-549 when it is used in combination with nivolumab (Opdivo®). Opdivo is a type of immunotherapy called a PD-1 (programmed cell death-1) inhibitor. Blocking PD-1 helps immune cells see and go after cancer cells. Opdivo is approved to treat at least eight types of cancer. Its use in breast cancer is considered experimental. IPI-549 is an investigational targeted therapy that blocks an enzyme called PI3K, which plays a role in cancer cell growth.

Phase 1 Open Label, Multicenter Study of MK-1454 Administered by Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab for Patients With Advanced/Metastatic Solid Tumors or Lymphomas (NCT03010176)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer and have a tumor that has not responded to, or has stopped responding to, other treatments.

This study will determine the best dose and safety of MK-1454, an immunotherapy drug that earlier studies suggest may make tumors more likely to respond to pembrolizumab (Keytruda®). Keytruda is a type of immunotherapy called a PD-1 inhibitor. It gets the immune system to go after cancer cells. It is approved to treat certain types of cancer, but not breast cancer. This study also is enrolling patients with other types of cancer.

Multi-center, Phase 1, Open-Label Study of DCC-3014 to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Tumors (NCT03069469)

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, the effect (good or bad) and best dose of DCC-301, an investigational immunotherapy that works by targeting CSF1R, a protein that can suppress the immune system. This study is also recruiting individuals with other types of advanced 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.

Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA) (NCT03167619)

Summary

To take part in this study, you must have advanced (some stage III that is inoperable) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-), have already been treated with at least three cycles of a platinum-based chemotherapy and shown response, and have had no more than two prior chemotherapy regimens for metastatic breast cancer.

This study will compare the effects (good or bad) of using the targeted therapy olaparib (Lynparza®) alone or with an immunotherapy drug. Lynparza is approved to treat HER2-negative metastatic breast cancer in patients who test positive for an inherited BRCA mutation. It is a PARP inhibitor, a drug that blocks the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 (programmed cell death ligand-1) inhibitor. It has been approved to treat certain other types of cancers, and its use in breast cancer is considered experimental.

A Phase 1a/1b Study of a Novel Anti-PD-L1 Checkpoint Antibody (LY3300054) Administered Alone or in Combination With Other Agents in Advanced Refractory Solid Tumors (Phase 1a/1b Anti-PD-L1 Combinations in Tumors-PACT) (NCT02791334)

Summary

To take part in this study you must have locally advanced (stage III) or metastatic (stage IV) breast cancer that is hormone receptor positive and HER2-negative or tests positive for high microsatellite instability (MSI-H). You must also have had at least 1 but no more than 3 chemotherapy regimens in the metastatic setting.

This study is testing the safety and effects (good or bad) of LY3300054 when it is used alone or in combination with a targeted therapy or an immunotherapy. LY3300054 is a type of immunotherapy called a checkpoint inhibitor. There are three other drugs being used in this study. LY3321367 is also an investigational checkpoint inhibitor. Ramucirumab (Cyramza) is a targeted therapy that blocks VEGFR-2, which keeps tumors from forming new blood vessels. It is approved to treat certain types of solid tumors, but not breast cancer. Abemaciclib (Verzenio) is a CDK 4/6 inhibitor approved to treat HR positive and HER2-negative metastatic breast 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 A166 is an antibody-drug conjugate (ADC). It combines chemotherapy with targeted therapy, allowing it to deliver the chemotherapy directly to the cancer cells. This trial is also enrolling patients with other types of solid tumors.

A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast Cancer (NCT03371017)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer. This study is evaluating the safety and effects (good or bad) of giving chemotherapy with an immunotherapy to giving chemotherapy with a placebo. The immunotherapy drug being used in this study is atezolizumab (Tecentriq®). The chemotherapy drugs used in this study are gemcitabine (Gemzar®), carboplatin (Paraplatin®) and capecitabine (Xeloda®). Gemzar is a chemotherapy drug used to treat breast cancer. Paraplatin is a platinum-based chemotherapy drug that is commonly used to treat triple negative breast cancer. Xeloda is commonly used to treat metastatic breast 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).

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.

BRE 17107: A Phase Ib/II Trial of Atezolizumab (an Anti-PD-L1 Monoclonal Antibody) With Cobimetinib (a MEK1/2 Inhibitor) or Idasanutlin (an MDM2 Antagonist) in Metastatic ER+ Breast Cancer (NCT03566485)

Summary

To take part in this study, you must have ER positive advanced (some stage III) or metastatic (stage IV) breast cancer.

This study is investigating the safety and effects (good or bad) of giving an immunotherapy along with a targeted therapy. The immunotherapy used in this study is the PD-L1 inhibitor atezolizumab (Tecentriq®). It works by stimulating the body's immune system to go after cancer cells. It is approved to treat certain types of cancers but its use in breast cancer is considered experimental. The two targeted therapies being used in this study are cobimetinib (Cotellic®), an MEK-targeted therapy approved to treat melanoma, and idasanutlin, a targeted therapy being studied in clinical trials.

A Phase II Study of Nivolumab Combined With Bicalutamide and Ipilimumab in Metastatic HER2-negative Breast Cancer (NCT03650894)

Summary

To take part in this study you must be a woman with HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer.

This study is testing the safety and effects (good or bad) of using a combination of nivolumab (Opdivo®), ipilimumab (Yervoy®), and bicalutamide (Casodex®). Opdivo® is a type of immunotherapy that gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). Yervoy is an immunotherapy that works by blocking a protein called CTLA-4. Yervoy and Opdivo are approved to be used together to treat patients with melanoma and certain other cancers. Their use in breast cancer is considered experimental. Casodex is an anti-androgen drug used to treat prostate cancer. Some breast cancers contain androgen receptors. Laboratory studies suggest these tumors may respond to anti-androgen therapies.

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.

TALAVE: A Pilot Trial of Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer (NCT03964532)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) breast cancer that has not been treated with a PARP inhibitor.

This study is investigating the safety and effects (good and bad) of talazoparib (Talzenna®) when it is used along with avelumab (Bavencio®). Talzenna is a type of targeted therapy called a PARP inhibitor. It is approved to treat patients with an inherited BRCA mutation who have advanced HER2-negative breast cancer. Bavencio is a type of immunotherapy called a PD-L1 inhibitor. It is approved to treat certain types of lung cancer. Its use in breast cancer is considered experimental.

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.

An International, Phase 3, Multicenter, Randomized, Open- Label Trial Comparing Balixafortide in Combination With Eribulin Versus Eribulin Alone in Patients With HER2 Negative, Locally Recurrent or Metastatic Breast Cancer (NCT03786094)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) HER2 negative breast cancer that has been treated with chemotherapy.

This study is comparing the safety, effectiveness and side effects of using eribulin (Halaven®) alone or in combination with balixafortide. Halaven is a chemotherapy drug used to treat advanced breast cancer. Balixafortide is an investigational immunotherapy drug that targets CXCR4.

A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (NCT03752398)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options.

This study is investigating the safety, effects (good and bad) and the best dose of an experimental immunotherapy called XmAb®23104. The drug targets both PD-1 (programmed cell death protein 1) and ICOS (inducible T-cell co-stimulator). This study is enrolling patients with other types of metastatic cancers.

A Phase 1b, Open-Label, Dose Escalation Study of PRS-343 in Combination With Atezolizumab in Patients With HER2-Positive Advanced or Metastatic Solid Tumors(NCT03650348)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) HER2 positive breast cancer and have been treated with at least one systemic therapy.

This study will investigate the best dose, safety and effects (good and bad) of PRS-343 when it is given along with atezolizumab (Tecentriq®). PRS-343 is a new type of HER2-targeted therapy. Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor. It is approved to treat advanced triple-negative breast cancer, when used along with paclitaxel, in patients whose tumor tests positive for PD-L1.

A Phase II Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients: Big Ten Cancer Research Consortium BTCRC-BRE16-042 (NCT03393845)

Summary

To take part in this study, you must have HR-positive, HER2-negative advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good and bad) of using pembrolizumab (Keytruda®) along with fulvestrant (Faslodex®) to treat HR+, HER2- advanced breast cancer. Keytruda is type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancers, but not breast cancer. Faslodex is a hormone therapy that is used to treat hormone sensitive breast cancer in postmenopausal women.
This is a Phase II trial

A Phase 1a/1b, Open-label First-in-human Study of the Safety, Tolerability and Feasibility of Gene-edited Autologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination With Anti-PD-1 to Patients With Locally Advanced or Metastatic Solid Tumors(NCT03970382)

Summary

To take part in this study you must have metastatic (stage IV) estrogen receptor-positive breast cancer that has been treated with at least one standard therapy.

This study is evaluating the safety and the effects (good or bad) of an experimental T cell immunotherapy called neoTCR-P1 when it is given with or without nivolumab (Opdivo®). NeoTCR-P1 makes a patient's T cells target a neoepitope (neoE) that is found on their cancer cells. Opdivo is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental.

A Phase Ib Investigation of Pembrolizumab in Combination With Intratumoral Injection of Clostridium Novyi-NT in Patients With Treatment-Refractory Solid Tumors (NCT03435952)

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, effects (good and bad) and best dose of a type of bacteria that researchers believe will prime tumors to respond to an immunotherapy. The bacteria have been modified to remove the chemicals that are poisonous to humans. The bacterial therapy being used in this study is clostridium novyi-NT. The immunotherapy being used in this study is the PD-1 inhibitor pembrolizumab (Keytruda®). Keytruda stimulates the body's immune system to go after cancer cells. It is approved to treat select types of cancers. Its use in breast cancer is considered experimental. You will also receive the antibiotic, doxocyclin. It is given to help keep the growth of the bacteria clostridium novyi-NT under control.

Phase II Study of Pembrolizumab and Mifepristone in Patients With Advanced HER2-negative Breast Cancer (NCT03225547)

Summary

To take part in this study, you must have HER2-negative advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good and bad) of using mifepristone and pembrolizumab (Keytruda®) together to treat HER2-negative advanced breast cancer. Mifepristone is a steroid that has been shown to block the glucocorticoid receptor. Researchers think blocking the glucocorticoid receptor may make Keytruda more effective. Keytruda is a type of immunotherapy called a PD-1 inhibitor. It gets the immune system to go after cancer cells. It is approved to treat certain types of cancer, but not breast cancer.

Phase I Study of Adoptive Immunotherapy for Advanced ROR1+ Malignancies With Defined Subsets of Autologous T Cells Engineered to Express a ROR1-Specific Chimeric Antigen Receptor (NCT02706392)

Summary

To take part in this study you must have metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has not responded to other treatment options and that tests positive for ROR1.

This study is assessing the safety, effects (good and bad) and best dose of an experimental CAR-T immunotherapy that targets cancer cells that test positive for ROR1. CAR-T is a personalized immunotherapy made from a patient's white blood cells. The blood cells are removed from the patient and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. The cells are then infused back into the patient in the hospital. The CAR-T therapy being used in this study trains the immune system to attack ROR1-positive tumor cells. It is given along with the chemotherapy drugs fludarabine phosphate and cyclophosphamide. These drugs are given to deplete lymph cells. This study is also enrolling patients with other types of ROR1-positive metastatic tumors.

Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination With Pembrolizumab for First-Line Treatment of Patients With Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer (NCT03310957)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer. This study is looking at the safety and effects (good or bad) of using SGN-LIV1A along with pembrolizumab (Keytruda®) to treat triple negative advanced or metastatic breast cancer. SGN-LIV1A is an investigational drug that targets a protein called LIV-1 that is found on some tumor cells. Keytruda® is a type of immunotherapy drug called a PD-1 inhibitor. It blocks the PD-1 (programmed cell death-1) protein, making it possible for the body's immune system to go after cancer cells. Keytruda is not approved to treat breast cancer. It is approved to treat certain other types of cancer.

A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors (NCT03170960)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has already been treated with at least one line of therapy.

This study will assess the safety, best dose, and effects (good and bad) of cabozantinib (Cabometyx®) when it is used alone or with atezolizumab (Tecentriq®). Cabometyx is a targeted therapy that blocks some of the signals that tell cancer cells to grow and divide and that stimulate the blood vessels the cancer cells need grow. It is approved to treat kidney and liver cancer. Its use in breast cancer is considered experimental. Tecentriq is a type of immunotherapy called an immune checkpoint inhibitor. It is approved for use in combination with the chemotherapy drug Abraxane® (nab-paclitaxel) to treat advanced triple-negative, PD-L1-positive breast cancer. This study also is enrolling patients with other types of cancer.

A Basket Study: A Phase I/II, Open-label, Multi-center Study of the Safety and Efficacy of BLZ945 as Single Agent and in Combination With PDR001 in Adults Patients With Advanced Solid Tumors (NCT02829723)

Summary

This study has two parts. To enroll in the first part, you must have metastatic breast cancer. To enroll in the second part, you must have metastatic triple negative breast cancer. This study is investigating whether a new type of targeted cancer drug is safe and effective when it is given alone or with an immunotherapy drug. This is the first study to test this new targeted drug in cancer patients. The targeted drug being used in this study is called BLZ945. It targets a receptor called CSF1R that plays a role in tumor growth. Some patients who enroll in this study will also receive an immunotherapy drug called PDR001. This study is also enrolling patients with other types of metastatic cancers.

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.

A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer (NCT03800836)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-).

This study is evaluating the safety and effects (good and bad) of using ipatasertib in combination with atezolizumab (Tecentriq®) and either paclitaxel (Taxol®) or nab-paclitaxel (Abraxane®). Ipatasertib is an investigational targeted therapy that blocks a protein called AKT that helps cancer cells divide and grow. Tecentriq is an immunotherapy that is approved for use in combination with Taxol to treat PD-L1-positive advanced triple negative breast cancer. Taxol and Abraxane are chemotherapy drugs used to treat breast cancer.

A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination With ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors (NCT03821935)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has been treated with at least one systemic therapy.

The study is investigating the safety, best dose and effects (good and bad) of ABBV-151 when it used with or without ABBV-181. ABBV-151 is a targeted therapy that blocks a protein called GARP- TGF-β1. ABBV-181 is an experimental PD-1 inhibitor. This type of immunotherapy, called a checkpoint inhibitor, gets the immune system to see and go after cancer cells.

A Phase 1B Dose Escalation Trial of Human Anti-4-1BB Agonistic Antibody PF-05082566 in Combination With Adotrastuzumab-Emtansine or Trastuzumab in Patients With HER2-Positive Advanced Breast Cancer (NCT03364348)

Summary

To take part in this study you must have HER2 positive advanced (some stage III) or metastatic (stage IV) breast cancer.

This study is investigating the safety and effects (good or bad) of using utomilumab (PF-05082566) with trastuzumab emtansine (Kadcyla®) or trastuzumab (Herceptin®). Utomilumab is an investigational immunotherapy that targets 4-1BB (CD-137), a molecule that stimulates the immune system. Herceptin is a HER2-targeted therapy approved to treat HER2 positive breast cancer. Kadcyla is an antibody-drug conjugate (ADC). It uses Herceptin to deliver the chemotherapy drug DM1 directly to the cancer cells. It is approved to treat HER2 positive metastatic breast cancer.

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

Summary

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

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.

A Phase II Study of Triple Combination of Atezolizumab + Cobimetinib + Eribulin (ACE) in Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer (NCT03202316)

Summary

To take part in this study, you must have inflammatory advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have already been treated with a chemotherapy that your cancer progressed on or did not respond to. In this study, researchers will determine the safety and effect (good or bad) of using a combination of immunotherapy, targeted therapy and chemotherapy to control metastatic inflammatory breast cancer. Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor. It is FDA approved to treat certain types of bladder and lung cancer. Cobimetinib (Cotellic®) is a new targeted therapy called an MEK inhibitor. It is approved to treat certain types of melanoma. Eribulin (Halaven®) is a chemotherapy drug approved for treating metastatic breast cancer.

A Phase 1 Study of an Autologous ACTR T Cell Product in Combination With Trastuzumab, a Monoclonal Antibody, in Subjects With HER2-Positive Advanced Malignancies (ATTCK 34-01) (NCT03680560)

Summary

To take part in this study you must be a woman or man with HER2 positive metastatic (stage IV) breast cancer that has already been treated with other HER2 targeted therapies.

This study is looking at the safety and effects (good or bad) of new type of immunotherapy, called ACTR T cell product (ACTR707 or ACTR087), when it is given in combination with trastuzumab (Herceptin®). ACTR T cell product is made from the patient's own T cells, which are collected at the beginning of the study and then infused back into the patient. ACTR (Antibody-Coupled T-cell Receptor) modified T cells combine immunotherapy with a targeted therapy. Herceptin® is a HER2 targeted therapy used to treat breast cancer.

A Phase II Randomized Study to Evaluate the Immunologic and Antitumor Activity of Concurrent VRP-HER2 Vaccination and Pembrolizumab for Patients With Advanced HER2-overexpressing Breast Cancer (NCT03632941)

Summary

To take part in this study you must have recurrent or advanced (some stage III) or metastatic (stage IV) HER2 positive breast cancer.

This study is to comparing the safety and effects (good or bad) of using the investigational tumor vaccine VRP-HER2 alone, to pembrolizumab (Keytruda®) alone, and to both treatments together. The VRP-HER2 cancer vaccine is designed to activate the immune system to go after HER2 positive cancer cells. Keytruda is a type of immunotherapy called a PDL-1 inhibitor. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.

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.

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®).

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005) (NCT03797326)

Summary

To take part in this study you must have triple negative (ER-, PR-, HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer and have already had one or two treatment regimens.

This study is evaluating the safety and effects (good and bad) of using pembrolizumab (Keytruda®) along with lenvatinib (Lenvima®). Keytruda is a type of immunotherapy called a PD-1 inhibitor. It stimulates the body's immune system to go after cancer cells. It is approved to treat certain types of cancers, but its use in breast cancer is considered experimental. Lenvima is a targeted therapy that blocks vascular endothelial growth factor receptor 2 (VEGFR2). It is approved for treating patients with certain types of thyroid, kidney and liver cancers. Its use in breast cancer is considered experimental. This study will also include people with other types of cancers.

A Phase 1b Study of Safety and Immune Response to PVX-410 Vaccine Alone and in Combination With Pembrolizumab in HLA-A2+ Patients With Metastatic Triple Negative Breast Cancer (TNBC) (NCT03362060)

Summary

To take part in this study you must be a woman with advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. In addition, your tumor must test positive for the HLA A2 protein. This test will be done by the research team. PVX-410 is a new type of vaccine that may help the immune system find and attack cancer cells. Pembrolizumab (Keytruda®) is type of immunotherapy drug called a PD-1 inhibitor that has been approved to treat some cancer types, but not breast cancer. It gets the immune system to go after cancer cells by blocking a protein called programmed cell death (PD-1).

Focused Ultrasound Therapy to Augment Antigen Presentation and Immune-Specificity of Checkpoint Inhibitor Therapy With Pembrolizumab in Metastatic Breast Cancer (NCT03237572)

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 at least one prior line of therapy in the metastatic setting. This study will evaluate the safety and effects (good and bad) of using high-intensity focused ultrasound (HIFU) along with Keytruda to treat metastatic breast cancer. HIFU is a treatment that works to kill cancer cells with high frequency sound waves. Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. It stimulates the body's immune system to go after cancer cells.

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Hormone Receptor-Positive HER2-Negative Breast Cancer (MORPHEUS-HR+ Breast Cancer) (NCT03280563)

Summary

To take part in this study, you must have HR-positive, HER2-negative advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have already been treated with a cyclin-dependent kinase (CDK) 4/6 inhibitor such as palbociclib/Ibrance®, ribociclib/LEE011, or abemaciclib/LY2835219, that your cancer progressed on or did not respond to. This trial is studying 5 different treatment options. Women will receive one, two, or three of the following drugs: the immunotherapy atezolizumab (Tecentriq®), a PD-L1 (programmed cell death-ligand 1) inhibitor approved to treat certain types of bladder and lung cancer; the targeted therapy cobimetinib (Cotellic), which blocks the MEK protein and is approved to treat certain types of melanoma; fulvestrant (Faslodex®), a standard chemotherapy used to treat breast cancer; ipatasertib (GDC-0068), a new type of cancer drug that works by blocking the Akt protein; bevacizumab (Avastin), a monoclonal antibody that keeps tumors from growing the blood vessels they need to survive and is used to treat HER2-negative metastatic breast cancer.

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer (Morpheus-TNBC) (NCT03424005)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer that progressed during or following first-line metastatic treatment with chemotherapy. This study is investigating the safety and effectiveness of 7 different immunotherapy-based treatment combinations in women and men with triple negative (ER-/PR-/HER2-) breast cancer. The immunotherapy being used in this study is atezolizumab (Tecentriq®). It is a PD-L1 inhibitor that works by stimulating the body's immune system to go after cancer cells. It is approved to treat certain types of urinary, bladder and lung cancer. The targeted therapies being used in the study are Ipatasertib (GDC-0068), SGN-LIV1A, bevacizumab (Avastin®) and cobimetinib (Cotellic®). The chemotherapies being used in this study are capecitabine (Xeloda®), gemcitabine (Gemzar®), carboplatin (Paraplatin®) and eribulin (Halaven®).

A Phase Ib Trial of M7824 and Eribulin in Patients With Metastatic Triple Negative Breast Cancer (TNBC) (NCT03579472)

Summary

To take part in this study you must be a woman or man with triple negative (ER- PR- HER2-) metastatic (stage IV) breast cancer

This study is designed to find the best dose of M7824 to use with eribulin (Halaven). M7824 is an investigational immunotherapy drug. It gets immune cells to see cancer cells by blocking PD-L1 and TGF-beta. Halaven is used to treat patients who have already had at least two other anticancer medicines for their metastatic breast cancer and who have already been treated with an anthracycline and a taxane for either early or advanced breast cancer

A Randomized, Phase II Study Comparing Trastuzumab and Vinorelbine in Combination With Avelumab or Avelumab and Utomilumab (41BB/CD137 Agonist), in Patients With HER2-positive Metastatic Breast Cancer Who Have Progressed on Prior Trastuzumab and Pertuzumab (NCT03414658)

Summary

To take part in this study, you must have HER2 positive advanced (stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good or bad) of three different drug combinations in advanced HER2 positive breast cancer. The drugs being used in this study are: trastuzumab (Herceptin®), vinorelbine (Navelbine®) avelumab (Bevancio®) and utomilumab (PF-05082566). Herceptin is a targeted therapy routinely used to treat HER2-positive breast cancer. Navelbine®) is a chemotherapy drug used to treat HER2-positive breast cancer. Avelumab (Bevancio®) and utomilumab (PF-05082566) are immunotherapies that work by stimulating the body's immune system to go after cancer cells. Both work by blocking a protein called PD-L1. Bevancio is approved to treat metastatic Merkel cell carcinoma and urothelial (bladder) cancers. It's use is considered experimental in breast cancer. Utomilumab is an experimental treatment.

Pilot Open Label Clinical Trial Evaluating the Safety and Efficacy of Chemokine Modulation to Enhance the Effectiveness of Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer (NCT03599453)

Summary

To take part in this study you must be a woman with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options.

This study will investigate the safety and effects (good and bad) of using chemokine modulation therapy before treatment with pembrolizumab (Keytruda®). Keytruda is a type of immunotherapy drug called a PD-1 (programmed cell death-1) inhibitor. It is approved to treat at least 10 different types of cancer. Its use in breast cancer is considered experimental. Small proteins called chemokines help get the immune cells to specific organs. Celecoxib (Celebrex®), recombinant interferon alfa-2b, and rintatolimod (Ampligen) each works in a different way to get chemokines to an organ. Chemokine modulation therapy may make Keytruda more effective.

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

Phase II Study of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Anti-NY ESO-1 Murine TCR-Gene Engineered Lymphocytes (NCT01967823)

Summary

To take part in this study you must have locally advanced (stage III) or metastatic (stage IV) breast cancer that tests positive for NY-ESO-1.

This study is evaluating the safety and effects (good and bad) of treating cancer with white blood cells that have been modified in a lab to target NY-ESO-1 on cancer cells. For the procedure, your white blood cells are removed, modified, and then infused back into your body along with Aldesleukin, a drug that enhances immune function. You will also receive the chemotherapy drugs cyclophosphamide (Cytoxan®) and fludarabine (Fludara®).You will be admitted to the hospital for some of the procedure. This trial also is enrolling patients with other types of metastatic cancer.

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.

Palbociclib After CDK and Endocrine Therapy (PACE): A Randomized Phase II Study of Fulvestrant, Palbociclib, and Avelumab for Endocrine Pre-treated ER+/HER2- Metastatic Breast Cancer (NCT03147287)

Summary

To take part in this study, you must have HR+, HER2-negative locally recurrent (some stage III) or metastatic (stage IV) breast cancer. You must have already been treated with a CDK4/6 inhibitor in combination with an anti-estrogen therapy. This study is investigating the safety and effects (good and bad) of using fulvestrant (Faslodex®) alone, in combination with Ibrance®, and in combination with Ibrance and Bavencio®. Faslodex is the anti-estrogen drug used in this study. Palbociclib (Ibrance®) is approved to treat HR+, HER2-negative breast cancer in combination with an anti-estrogen therapy. Avelumab (Bavencio®) is a type of immunotherapy called a PD-L1 inhibitor. It is approved to treat a type of blood cancer.
This is a Phase II trial

Phase 2 Study of MCLA-128-based Combinations in Metastatic Breast Cancer (MBC): MCLA-128/Trastuzumab/Chemotherapy in HER2-positive MBC and MCLA-128/Endocrine Therapy in Estrogen Receptor Positive and Low HER2 Expression MBC (NCT03321981)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer and a tumor that is HER2-positive or ER-positive with low HER2-expression. This study is evaluating the effects (good or bad) of an experimental immunotherapy drug called MCLA-128. If your tumor is HER2+, you will receive MCLA-128 along with the HER2-targeted drug trastuzumab (Herceptin®). If you are ER+, you will receive MCLA-128 along with the same endocrine therapy you received before entering the study: fulvestrant (Faslodex®), exemestane (Aromasin®), letrozole (Femara®) or anastrozole (Arimidex®). The chemotherapy drug used in this study is vinorelbine (Navelbine®).
This is a Phase II trial