We are studying the natural course of autoimmune hemolytic anemia (AIHA). If you are an adult between 18 and 120 years old, receive care at Columbia University Irving Medical Center-New York Presbyterian Hospital, are willing to provide a blood sample every 6 months for research, and have one of the following diagnoses: AIHA, mixed AIHA, Evans Syndrome, or…
The purpose of this study is to develop a cohort of patients with early scleroderma and to collect data on clinical outcomes, radiological tests, laboratory tests, and to obtain biological specimens for testing.
This research is being done to determine how variations in genes may explain the different risk to develop scleroderma (or CREST) seen in African American patients compared to other populations. People who are African American with scleroderma (or CREST) may join. This research involves a blood draw and physical exams.
The purpose of this study is to compare V940 plus pembro given after surgery to a placebo plus pembro given after surgery and to study how effective the study drug is. A placebo looks like a study drug, but it has no active ingredients. V940 has not yet been approved by the Food and Drug Administration (FDA). Pembrolizumab is FDA approved but it has not…
You are being asked to participate in this study because you have been diagnosed with a progressive desmoid tumor. The purpose of this study is to see if the study drug, called AL102 (referred to from now on as the study drug), is safe and effective in people with progressive desmoid tumors. The study will also look at how your body responds to the study…
The purpose of this study is to understand the life course of PIRD patients and their family members that have the same gene change but do not have the same symptoms. PIRD is mostly due to inherited changes in the genes that normally have immune cells fight infections and regulate the immune system. There are many types of problems that patients with PIRD…
We are inviting patients with active Rheumatoid Arthritis (RA) to help us better understand how treatment options affect inflammation in soft tissues. With a combination of blood work, a full-body FDG PET-CT scan, questionnaires, and a soft tissue biopsy (from an area around the belly button), we hope to see how RA interacts with these multiple areas of…
The purpose of this study is to determine the safety and efficacy of CMP-001 when given in combination with nivolumab for patients with unresectable (not capable of being surgically removed) or metastatic (cancer spreads to a different body part from where it started) melanoma. CMP-001 will be given as an injection into the tumor and nivolumab will be given…
We are looking for patients who have been diagnosed with Psoriatic Arthritis (PsA) to help us better understand the involvement of inflammation on the body. With a combination of bloodwork, a bone density scan, questionnaires, and a one-time soft tissue biopsy (from an area around the belly button), we hope to see how PsA interacts with these multiple areas…
The purpose of this study is to test the good and bad effects of the drugs called belinostat and SGI-110 (guadecitabine). These drugs could shrink your cancer, but they could also cause side effects. The study doctors hope to learn if the study drugs will shrink the cancer more often than observed with other standard treatment options. We dont know if…
This phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere…
The purpose of this study is to evaluate the effectiveness and safety of an investigational drug, unesbulin. This investigational drug is being studied in unresectable or metastatic, relapsed, or refractory leiomyosarcoma along with Dacarbazine. Dacarbazine is a drug that is FDA-approved for the treatment of other types of cancer and recommended by the…
The study drug, CFT8634, is an investigational therapy that has been shown in animal studies to help break down the BRD9 protein, an important protein in the body that helps SMARCB-null tumors, such as your own, to grow. CFT8634 is able to do so by using the body's own protein-recycling equipment. (In short, your cells are capable of breaking down…
The purpose of this research study is to determine the effectiveness and safety of envafolimab, an experimental drug that is not approved for use, when given alone or in combination with ipilimumab to stimulate your immune system to attack cancer cells. Envafolimab is an experimental (investigational) cancer drug that overrides the PD-1/PD-L1 checkpoint,…
The experimental drug called INBRX 109 has been developed as a treatment for unresectable or metastatic conventional chondrosarcoma. The purpose of this study is to learn about the effects of the study drug, INBRX-109 on you, your immune system, and your cancer. This study is being done to understand if INBRX-109 is effective against your chondrosarcoma and…
This research study is sponsored by ImmunogenX and The National Institutes of Health (NIH, Bethesda, MD). The objective of this study is to determine if the investigational product (latiglutenase) will help decrease symptoms in subjects with celiac disease while maintaining a gluten-free diet while undergoing periodic gluten exposure. In addition, this…
The purpose of this study is to evaluate the effectiveness of a new investigational drug, ATX-101, for the treatment of dedifferentiated liposarcoma and leiomyosarcoma. ATX-101 is an intravenous (IV) drug which blocks the interaction of a protein called PCNA with a number of stress response proteins. These interactions are thought to be important for cancer…
The purpose of this study is to learn about the safety, tolerability, and effectiveness of an investigational drug called milademetan as compared to the use of trabectedin. In this study, subjects will be randomly assigned (like flipping a coin) to receive one of two study drugs: milademetan or trabectedin. This is an open-label study, meaning you will know…
Celiac disease is associated with an increased risk of osteoporosis and fractures. Men with celiac disease were found to be at higher risk for metabolic bone disease compared to women with celiac disease. The mechanisms underlying metabolic bone disease in celiac disease remain incompletely understood. The goal of this study is to assess skeletal…
The purpose of this research study is to test the safety and efficacy of AU-011 at different doses and different number of doses of study drug when it is injected into the suprachoroidal space of the eye with one or two laser light applications and to find out what effects, if any, it has on research participants with a choroidal melanoma tumor or…
This study consists of two treatment groups, Part 1 and Part 2. The purpose of this study is to: Part 1 - Test the safety and tolerability of the study drug IN10018, see how well the drug works on your metastatic uveal melanoma, and see how your body handles the drug. Part 2 - Test the safety and tolerability of the study drug IN10018 with cobimetinib, see…
The purpose of this study is to: 1. Compare treatment with chemotherapy (paclitaxel) alone to using a combination of nivolumab plus chemotherapy (paclitaxel) treatment in patients with angiosarcoma who have not been treated with paclitaxel chemotherapy alone. 2. Evaluate the effect of nivolumab in combination with cabozantinib on angiosarcoma (cancer) in…
The purpose of this study is to test the study drug, BI 907828 for safety, effectiveness, and side effects when compared to receiving the standard treatment, doxorubicin, in subjects with dedifferentiated liposarcoma (DDLPS). BI 907828 has proven to minimize a critical protein interaction between MDM2 and p53, two proteins in your body, which when their…
The purpose of this study is to evaluate the effectiveness of a new investigational drug, PTC596, used in combination with dacarbazine, for the treatment of locally recurrent, unresectable, or metastatic relapsed/refractory leiomyosarcoma, a type of soft tissue sarcoma. The purpose of this study is to evaluate whether adding PTC596 to dacarbazine is safe…
The purpose of this study is to find out if an investigational drug, called ADP-A2M4, is safe and how well it works in attacking Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (MRCLS) cancer cells. The study involves taking certain types of immune cells from the blood, called T cells, and changing them in a laboratory before putting them back into the…
The purpose of the study is to evaluate the effectiveness (how well the drug works) of the investigational drug called bempegaldesleukin when combined with drug nivolumab in comparison with nivolumab alone after complete resection (removal of all sites of known disease) of melanoma in participants at high risk of cancer returning after surgery (recurrence).
This research study is a phase II clinical trial that will study the combination of adjuvant nivolumab and ipilimumab for the treatment of adult subjects with completely treated high-risk ocular melanoma. This study is being done to see if the combination of the study drugs is safe and effective in preventing the return of their cancer. If you are eligible…
The purpose of this study is to test the safety of a study drug called AMG 232 given with radiation in patients with soft tissue sarcoma (STS) prior to surgery. The AMG 232 is investigational. It has been tested in other cancers but not yet in sarcoma. AMG 232 has not been tested using the dosing schedule in this study and it has not been tested with…
You are being asked to participate in this study because you have been diagnosed with a progressive desmoid tumor. The purpose of this study is to see if the study drug, called AL102 (referred to from now on as the study drug), is safe and effective in people with progressive desmoid tumors. The study will also look at how your body responds to the study…
The purpose of this study is to test the safety and effectiveness of the study drug Obinutuzumab and to find out what effects, good or bad, it may have as an additional therapy in treating your lupus nephritis symptoms.
The purpose of this study is to find out more about the Amgen agent called talimogene laherparepvec in people with advanced melanoma when given in combination with another drug developed by Merck called pembrolizumab. Melanoma is a type of skin cancer. Advanced melanoma means the tumor is not removable by surgery or has spread to other parts of the body.
The purpose of this study is to find out which participants with melanoma respond best to nivolumab and ipilimumab treatment and to identify tumor and blood based markers that may predict response to the combination. This study is asking that participants submit tumor tissue samples from their initial tumor specimen and blood samples before they receive…
This study is for patients who have been diagnosed with systemic Lupus erythematosus (SLE). SLE is a disease in which the body mistakenly attacks healthy tissue. It can affect the skin, joints, kidneys, brain and other organs. The purpose of this study is to test the effects of an investigational (being tested) study drug, CC 220, in order to find out if CC…
The purpose of this study is to evaluate the effectiveness of preoperative radiation therapy used in combination with the immunostimulatory agent talimogene laherparepvec (T-VEC) to improve outcomes for patients with resectable soft tissue sarcomas, including soft tissue sarcoma (liposarcoma (excluding myxoid liposarcoma), leiomyosarcoma and…
We are doing a research study to learn more about why people with rheumatoid arthritis (RA) are prone to heart disease. We are recruiting patients diagnosed with Rheumatoid Arthritis without a personal history of heart disease. This study involves one initial full visit as described below, and a brief follow up visit that will take place approximately 2 or…
The purpose of the study is to find out if study drug belimumab is safe and effective in treating children with active lupus who are also taking other lupus medicine. Belimumab (also known as BENLYSTA hasbeen approved in the United States, Canada, and Europe for the treatment of adults with active SLEwho are receiving other lupus medicines but not yet…
The purpose of this research study is to learn more about adding the drug ADI-PEG 20 to a standard treatment regimen called gem-tax (the chemotherapy drugs gemcitabine and docetaxel) for subjects with bone and soft tissue sarcoma, and how the addition of ADI-PEG 20 affects the tumors response to treatment and the side effects you experience.
The purpose of this study is to find out whether a drug called iloprost is safe to use in people with systemic sclerosis (SSc) (Raynaud's phenomenon), and whether it may help decrease symptomatic digital ischemic episodes (episodes in the fingers).
This is a phase II research study for individuals with resectable, stage IIIB to IVM1a Melanoma. The research drug being studied is talimogene laherparepvec. Talimogene laherparepvec is still experimental and has not been approved by the Food and Drug Administration (FDA) for use in people with melanoma. The purpose of this study is to find out more about…
The purpose of this research study is to test the safety of Light-activated AU-011 at three different doses of the study drug and repeat dose regimens (two or three doses of highest safe dose) to find out what effects, if any, it has on research participants with a choroidal melanoma tumor. This study will have a high dose, a medium dose, and a low dose of…
The purpose of this study is to evaluate the safety and tolerability of an experimental investigational drug called ixazomib citrate (MLN9708) in patient with Lupus Nephritis. Lupus nephritis is a condition when the kidney is affected in the autoimmune disease known as systemic lupus erythematosus (SLE). SLE is a disease in which the immune system (the body…
The purpose of this study is to evaluate the safety and effectiveness of a new combination treatment involving two drugs: selinexor and ixazomib, for the treatment of dedifferentiated liposarcoma, malignant peripheral nerve sheath tumor, alveolar soft part sarcoma and Ewing sarcoma. The primary objective of the study is to determine the maximum tolerated…
The goal of this study is to test a new lupus drug. This drug interrupts the function of a chemical in the body called IL-6, and IL-6 may be overactive in people with lupus. ALX-0061 is a study drug that will be administered subcutaneously to subjects with moderate to severe active, seropositive Systemic Lupus Erythematosus (SLE) compared to placebo.
The purpose of this study is to determine the safety and effectiveness of the study drug nirogacestat for the treatment of desmoid tumors/aggressive fibromatosis (DT/AF). One group will receive the study medication, the other group will receive a placebo. After the initial phase of the study, participants may elect to participate in another phase of the…
The purpose of this study is to gather information on the safety of TH-302 and its effect on your cancer. This study will also look at how the drug is processed in the body. In addition, this study will collect data from blood, tumor, and imaging studies about your specific cancer such as the level of oxygen that is present. This may help us understand…
The purpose of this study is to compare the efficacy and safety of cobimetinib plus atezolizumab with the efficacy and safety of pembrolizumab in patients with a type of skin cancer called melanoma that has spread to other parts of the body (metastatic), cannot be removed by surgery (unresectable), and have not received any prior treatment.
The purpose of this research study is to determine if high-dose versus standard-dose regimens of encorafenib and binimetinib are safe and have positive effects in people who have melanoma brain metastasis and also have been found by their doctor to have a mutated gene called BRAFV600. The time frame for the study is approximately 2 years.
This study is for patients with Lambert-Eaton Myasthenic Syndrome (LEMS). The purpose of this study is to provide doctors and their patients access to amifampridine phosphate therapy for their patients with LEMS, CMS or downbeat nystagmus until the product becomes commercially available. The secondary purpose of the study is to assess the long-term safety…
The purpose of this study is to learn about the effects, safety, and proper dosage of tazemetostat in combination with doxorubicin for the treatment of soft tissue sarcoma. Doxorubicin is a common therapy for soft tissue sarcoma, but is not FDA approved in combination with tazemetostat. This study treatment combination may suppress or prevent tumor growth…
The purpose of this study is to find out if the drugs LEE011 and MEK162, administered in combination, are safe and effective in treating people who have melanoma. Specifically, this study will evaluate the effects of the combination of the two drugs, LEE011 and MEK162, in melanoma, carrying specific mutation in a gene called NRAS. The changes in the NRAS…
The purpose of this clinical trial is to learn about the ability of an experimental treatment XmAb5871 to maintain lupus disease activity improvement achieved by a brief course of disease-suppressing intramuscular (IM) steroid therapy in lupus patients.
The researchers hope to study the effectiveness of an investigational drug called AL3818 in people who have metastatic (meaning their disease has spread) or advanced ), specifically alveolar soft partsarcoma (ASPS), leiomyosarcoma (LMS) and synovial sarcoma (SS). The main purpose of the study isto learn the percentage of patients that respond to treatment…
The purpose of this study is to determine the efficacy and safety of abituzumab in subjects withsystemic sclerosis-associated interstitial lung disease (SSc-ILD).Abituzumab is an investigational drug that is being evaluated for the treatment of patients withsystemic sclerosis (SSc)-associated interstitial lung disease (SSc-ILD). Systemic sclerosis,…
Systemic sclerosis (SSc) is a systemic connective tissue disease characterized by fibrosis and atrophy, namely of the skin, internal organs, joints, and skeletal muscles. This is a double-blind, placebo-controlled trial to test the efficacy of abatacept (Orencia) on the treatment of diffuse cutaneous systemic sclerosis in patients with a disease duration of…
We are studying a medication to see if it is effective in reducing the disease activity of systemic lupus erythematosus (SLE), which is the most common form of lupus. You may qualify for the Achtar study if you have persistently active SLE, are 18 years of age or older, and: Have rash and/or arthritis as part of your SLE symptoms Are currently taking…
If you have active Systemic Lupus Erythematosus, also known as SLE or Lupus, you may be interested to learn about a clinical research study that is being conducted to study the safety and effectiveness of an investigational medication called ustekinumab for active Lupus. Eligible study participants will be provided with study medication and study-related…
The purpose of this study is to establish the safety profile of the study drug HuMax-AXL-ADC in a mixed population of patients with specified solid tumors. HuMax-AXL-ADC binds to a specific antigen called Axl, which is expressed on the tumor cells in the cancer types treated in this trial. When the trial drug binds to the antigen on the tumor cell, the…
The purpose of the first part (Phase I) of the study is to test the safety of navitoclax in combination with dabrafenib and trametinibat different doses to find out what effects, if any, it has on people. There will be about 18 people treated in this part of the study. The purpose of the second part of this study (Phase II) is to compare the good and bad…
Systemic sclerosis (SSc) is a systemic connective tissue disease characterized by fibrosis and atrophy, namely of the skin, internal organs, joints, and skeletal muscles. There are numerous manifestations of SSc that affect multiple organ systems. The major pulmonary manifestations of SSc, interstitial lung disease and systemic sclerosis-associated…
This is a 6-week randomized, double-blind trial of 4 different non-steroidal anti-inflammatory drugs in patients with axial spondyloarthritis to compare the change of pain score from baseline at 4 weeks to the change of pain score from baseline at 6 weeks. Patients with ankylosing spondylitis or axial spondyloarthritis who fulfills the inclusion and…
The purpose of this study is to determine the effectiveness and safety of a study drug called abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD). The study will also look at the following: How the study drug affects other symptoms of SSc-ILD -How safe the study drug is (i.e. if there are any side effects) -How the…
The main purpose of this research study is to test different doses of INCB059872 and see which doses are safe and tolerable in participants that have Ewing sarcoma. This study will research the effect that INCB059872 has on your cancer. Researchers will study the way INCB059872 come into and leave your body over time (pharmacokinetics). INCB059872 is a…
In this experimental study, researchers will try to find out if treatment of lupus nephritis with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab and CTX followed by treatment with belimumab is safe and if this drug combination can block the immune system attacks.
The purpose of this study is to determine how effective and safe the immune drug Nivolumab is for patients who have newly diagnosed cutaneous melanoma. Nivolumab is an anti-body, a type of human protein, that is being tested to see if it will allow the body's immune system to work against tumor cells. If you are eligible for the study, you will…
The purpose of this study is to determine if Acthar gel is a safe and effective therapy for patients with membranous (Class V) lupus nephritis. Class V lupus nephritis is associated with the development of chronic kidney disease and end-stage renal (kidney) disease, and there is no clear therapy for treatment. Currently used therapies arent completely…
The purpose of this study is to determine if the study drug toripalimab is safe, to determine future doses to give to patients with cancer, and to measure the amount of toripalimab in the blood. Up to approximately 240 subjects will be enrolled in Part B. The dose given in Part B will be 240 mg. The dose was chosen based upon safety data obtained from…
The study aims to compare the effect two different RA treatments on cardiovascular health in patients who are considering a treatment change. The study is recruiting patients who are only taking methotrexate and are switching treatment due to a lack of improvement. The trial will randomize participants to take a TNF inhibitor (Enbrel or Humira) in addition…