The main goal of this clinical trial is to determine if an investigational medication called VEL101 is safe, well tolerated, and effective in people receiving a new kidney transplant. Participants will be randomly assigned to 2 different doses of VEL-101 or to tacrolimus, which is standardly used post-transplant to prevent rejection. Participants will be…
The purpose of the study is to compare how well Rina-S works against ovarian cancer, primary peritoneal cancer, or fallopian tube cancer compared to chemotherapy drugs that are already approved and used for your type of cancer. You have an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. Rina-S is not…
This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with HIV compared to donors without HIV. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
The purpose of this study is to understand how liver disease affects thinking and memory, both before and after transplant. Participants will take a cognitive test, which will be a series of tasks and questions similar to a video game, at home on their own computers, tablets, or phones. This will take approximately 45 minutes, and participants will do this…
The purpose of this clinical research study is to develop a sample collection method that is less invasive than current endometrial sampling methods (uterine sample collection) and develop a diagnostic test from these samples which is as informative in diagnosing the absence of endometrial (uterine) cancer as currently available methods.
A complication that can occur after liver transplant (LT) is rejection, in which the patient's immune system damages the transplanted liver. This complication can be prevented with immunosuppressant medications, which are routinely used after LT. The main purpose of this study is to determine if bacteria in the intestine (gut microbiome) may affect the…
The purpose of this observational research study is to identify things that contribute to outcomes in patients with alcohol-associated liver disease who are being considered for liver transplant and who have less than 6 months of sobriety. We will look at many things including images of the liver and heart, blood tests, urine tests, stool tests and liver…
The main purpose of this study is to deeply characterize cognitive function in liver transplant recipients, differentiate among different causes of cognitive impairment, and identify contributors to cognitive impairment. Participants will receive a comprehensive neurological exam, cognitive assessment, neuropsychological testing, MRI of the brain, and blood…
The purpose of this study is to evaluate the safety of siplizumab when used as induction immunosuppression in patients with primary sclerosing cholangitis or autoimmune hepatitis undergoing liver transplantation. Induction immunosuppression drugs are very potent anti-rejection drugs that are given immediately after transplantation to prevent rejection.…
The purpose of this study is to learn more about the effects of functional status (also known as "frailty") using a physical test in patients with liver disease on their health outcomes. We are enrolling patients prior to liver transplantation, and will continue to assess their functional status post transplant. If you have any questions regarding…
The primary objective is to evaluate long-term outcomes in transplant recipients with HIV who receive livers from donors with HIV compared to donors without HIV. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
The primary objective is to determine whether using hearts from HIV+ donors for HIV+ recipients is safe with regard to major transplant-related and HIV-related complications. The primary outcome is patient survival at one year. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
The purpose of this study is to study the safety and feasibility of giving intestinal transplant patients CD34+ stem cells (the cells that make all the types of blood cells) obtained from their organ donor's bone marrow as an IV infusion post-transplant. Researchers will be looking to see whether this CD34+ cell infusion might help control rejection of…
The purpose of this sponsor initiated multi center registry is to collect additional data on the performance of the FDA Approved OCS Liver System and post transplant clinical outcomes for patients who are transplanted with an OCS Liver perfused donor liver in the real world setting. If you have any questions regarding this study, please contact the…
This purpose of this study is to understand the interaction between two different medications, tacrolimus and Paxlovid (nirmatrelvir/ritonavir), in patients who have had a kidney transplant and are being treated by their doctor for COVID-19 infection. Tacrolimus is an oral medication that is used standardly in kidney transplant recipients to prevent…
The goal of this clinical research study is to compare the outcomes of minimally invasive surgery (the investigational surgery) to laparotomy (the current standard of care) in women with Epithelial Ovarian Cancer (EOC) who receive chemotherapy before and after surgery. Researchers want to learn if one surgery can prevent the disease from returning for…
In this study, we will collect information from the medical record of pediatric liver transplant recipients who received live vaccines as part of their routine post-transplant care. This data will be combined with data from other centers across the United States and Canada to help give us a better understanding of the safety and efficacy of live vaccines in…
The main purpose of this study is to learn about the safety of REGN4018 and to find out what dose of REGN4018 can be given alone or in combination with cemiplimab to research subjects with ovarian cancer without too many side effects. The study will also look at the levels of REGN4018 and/or cemiplimab in the body and measure how well your body can remove…
The purpose of this research study is to learn if sacituzumab govitecan (also called SG) can improve lifespan and delay the growth or spread of the disease in participants with endometrial cancer when compared to chemotherapy (doxorubicin or paclitaxel). Sacituzumab govitecan is a type of drug called an antibody-drug conjugate. An antibody-drug conjugate (…
The purpose of this research is to learn about what effects, both good and/or bad, an experimental drug called TransCon IL-2 / has when given by itself or in combination with pembrolizumab, SOC chemotherapy, or TransCon TLR7/8 Agonist, or in combination with pembrolizumab and SOC chemotherapy. TransCon IL-2 / works by blocking the reproduction and spread of…
This is a 60-month adaptive to evaluate three siplizumab-based treatment regimens in kidney transplant recipients. The purpose of this research study is to see if the anti-rejection medications that patients normally take after transplant can be reduced or stopped completely by using several medications including the investigational drug siplizumab in the…
In this research study, we want to find out how well patients that receive a kidney from an HIV-positive (HIV+) donor do over 10 years compared to patients who receive a kidney from an HIV-negative (HIV-) donor. This research study is for adults who are HIV+ and are being evaluated for or are waitlisted to receive a kidney transplant. It is also available…
The purpose of the study is to collect scientific data on pediatric liver transplantation to learn more about how children do after liver transplant. Collecting these data is expected to help researchers learn more about liver transplant in children. This information may improve medical care of your child and other children who need and who have received…
The main purpose of this study is to determine if two surgical procedures, the usual approach of removing the fallopian tubes and ovaries and the other approach of removing the fallopian tubes at this time with the plan to remove the ovaries at a later time, are no different for ovarian cancer risk reduction in women with BRCA1 mutations who have completed…
Kidney transplant extends life, improves quality of life, and reduces healthcare costs. Unfortunately, there are not enough donated kidneys, so many people who need a transplant spend years on the waiting list. Kidneys from organ donors who have hepatitis C virus (HCV) are often thrown away, but these kidneys work well, and hepatitis C can be cured. The…
The purpose of this study is to determine if an investigational drug called tegoprubart (also known as AT1501) is safe and effective in preventing rejection in patients who are undergoing a kidney transplant for the first time. Participants will be randomly assigned to tegoprubart or standard treatment with tacrolimusat the time of transplant. If you have…
The primary objective of this study is to determine if an HIV-infected donor liver (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications. This study will evaluate if receiving a liver transplant from an HIV-infected deceased liver donor is safe with regards to survival and major transplant-related and HIV-related…
Participants are being invited to take part in a clinical research study because they have been diagnosed with locally advanced or metastatic solid tumors with mutations in the following genes: MRE11, RAD50, NBN, or CCNE1 amplification. If the participant takes part in the study, they will take an investigational drug referred to as ZN-c3 (Study Drug).…
The purpose of this research study is to test the safety and determine the highest tolerable dose of SL-172154 (study drug) that can be given with Pegylated Liposomal Doxorubicin (PLD) or Mirvetuximab Soravtansine (MIRV). Another purpose of this study is to understand if SL-127154 and PLD or MIRV is effective in managing ovarian cancer. The study drug, SL-…
Are you undergoing a stem cell transplant? You may be at high risk for infections after the transplant. This study is looking at the safety and effectiveness of an investigational medication for those who have undergone a stem cell transplant. Recovery after a stem cell transplant can already be challenging without the added worry of life-threatening viral…
XMT-1536 (upifitamab rilsodotin) is a targeted therapy, which means that it is directed specifically at a tumor. It is a type of antibody-drug conjugate; this means it has 2 parts that are joined together into one drug. The first part is an antibody that binds to NaPi2b (sodium-dependent phosphate transporter), a protein on the surface of the cells of your…
This study is testing a drug called GDC-8264, which is being developed to treat acute graft-versus-host-disease (acute GVHD). GDC-8264 is an experimental drug, which means health authorities have not approved GDC-8264 in combination with standard medications for the treatment of acute GVHD. The purpose of this study is to evaluate the effects, good or bad,…
The purpose of this study is to assess whether an investigational drug, called XmAb20717, has any effects on your cancer, and to determine if it is safe and well tolerated. XmAb20717 is a type of drug that can attach to 2 different proteins, call a bispecific antibody. These antibodies are designed to attach to a T-cell, a type of immune system cell, in…
The purpose of this study is to find out of the combination of the drugs abemaciclib and letrozole is better or worse than usual approach for your type of cancer. The usual approach is defined as care most people get for endometrial cancer. People who are not in a study are usually treated with either surgery, radiation, hormonal therapy or with…
By doing this study, researchers hope to learn more about the efficacy (how well the drug works) and safety (the drugs side effects) of MORAb-202 (farletuzumab ecteribulin) compared to approved chemotherapy medications in patients with platinum-resistant ovarian cancer. The study will evaluate two doses of MORAb-202. MORAb-202, is made up of two parts; an…
The purpose of this research is to study the effects of liver transplantation and standard immunosuppression on body composition in patients with compensated cirrhosis and hepatocellular carcinoma (HCC). Patients with a diagnosis of HCC and cirrhosis who are listed for a liver transplant will be enrolled in this study. If you agree to participate, you will…
Kidney transplant patients are at a higher risk for bone fractures compared to the general population. We are doing a clinical trial to examine the effects of 12-months of treatment with denosumab, a monoclonal antibody against RANKL, on bone density and strength as determined by bone imaging and by non-invasive measures of bone activity from blood and…
In this study, patients who are listed for a kidney or a liver transplant may be eligible for enrollment, asdetermined by their transplant doctors. The study is looking at patients who do not have hepatitis C virus (HCV) and provide their informed consent to receive a liver or kidney from a HCV positive donor. FDA approved medications that are used to…
This study is for patients who have had a lung transplant and whose doctors believe that their body is rejecting the new lung, resulting in damage to the transplanted lung or lungs. This condition is called Bronchiolitis Obliterans Syndrome (BOS). In some patients, BOS progressively worsens, causing more breathing difficulty, worse quality of life. We are…
The purpose of this study is to test the good and bad effects of olaparib in combination with temozolomide for the treatment of advanced uterine leiomyosarcoma (LMS). Olaparib and temozolomide could shrink your cancer, but could also cause side effects, which are described in the risks section below. The study doctors hope to learn if the study drug will…
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 see whether or not the medicine, Abatacept, when given after hematopoietic stem cell transplantation (HSCT) is effective in treating GVHD in children and adolescents with sickle cell disease (SCD). We are also planning to gather additional information about the safety of treating sickle cell disease with a hematopoietic stem…
This is a research study of a new drug for the treatment of new onset chronic graft versus host disease (cGVHD). Chronic GVHD is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted donor cells attack the transplant recipient's body. The current way to treat cGVHD is to use prednisone (a type of…
The purpose of this study is to determine if Nexavar (sorafenib), the study medication, is effective in preventing cancer recurrence in high risk patients following liver transplantation. The purpose of this study is to determine if sorafenib is a safe and effective treatment option for preventing the recurrence of liver cancer in high risk subjects…
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…
This is a Phase 3 multi-center open label randomized clinical trial. The purpose of this study is to learn more about which anti-rejection (or immunosuppressive) medications best protect infants, children, adolescents, and young adults after they have had a heart transplant. Two different drug regimens will be will be compared. All of these drugs are FDA-…
The purpose of this research study is to see if an investigational drug, BB3, is safe and effective forincreasing the amount of urine that a transplanted kidney will produce. An investigational drugis one that is not approved by the United States Food and Drug Administration (FDA). BB3 is agrowth factor-like drug, which means that it can affect cell…
This study is being done to determine if adding the investigational drugs (TSR-042 and niraparib) to standard of care treatment delays or prevents ovarian cancer recurrence (prevents the ovarian cancer from coming back).
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…
Subjects who undergo a kidney transplant require long term use of anti-rejection (immunosuppressive)drugs to prevent their body's immune system from attacking and damaging the newly transplanted kidney (rejection).The purpose of this study is to evaluate benefits and risks of two combinations(regimens) of immunosuppressive therapies: Thymoglobulin…
This research trial is designed to study the safety and effectiveness of combining the study drug, Natalizumab (Tysabri) with the standard treatment, the use of steroids, as a new treatment for acute graft versus host disease (acute GVHD). GVHD is the most common serious complication, after bone marrow transplant. GVHD occurs when the donor cells (the graft…
The purpose of this study is to investigate a new therapeutic regimen with or without steroids in the pediatric population. The aim is to find out whether everolimus is safe and has beneficial effects in children who receive a liver transplant. All children will receive a study drug called everolimus twice a day plus a reduced dose of cyclosporine or…
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, which involves research, is being done to see how well an investigational new drug and study device combination will work to treat people with pre-cancerous cells on the cervix caused by human papillomavirus (HPV). The treatment combination is testing a drug, called VGX-3100, given by injection and used with the study device,…
This is a prospective, randomized, multi-center, controlled study for subjects with end stage liver disease who require a liver transplant, comparing whole liver preservation via hypothermic machine perfusion (HMP) using the LLT System with Vasosol with livers preserved via static cold storage (which is standard of care). During Hypothermic Machine…
The purpose of this study is to determine if eculizumab is safe and could be used to prevent Delayed Graft Function (DGF) following kidney transplantation. DGF is an early complication of kidney transplantation. This condition occurs when the transplanted kidney does not recover instantly after transplantation and can take days to weeks before recovering…
The purpose of this study is to find out what effects, good or bad, cobimetinib and niraparib, given with or without atezolizumab, have on you and your cancer. In this study, you will receive either cobimetinib plus niraparib or cobimetinib plus niraparib plus atezolizumab. In addition, if you are assigned to receive cobimetinib and niraparib and your…
The main aim of this clinical trial is to know the effects (good or bad) that study drug lurbinectedin (PM01183), has on women with ovarian cancer. Lurbinectedin (PM01183), is an investigational drug. This means that the drug has not been approved by the Food and Drug Administration (FDA) for medical use in patients, but has only been approved for use in…
The main purpose of the study is to find out about whether the study drug is safe in humans and aneffective treatment in pediatric patients with acute Graft versus Host Disease (GVHD). GVHD mayoccur after a bone marrow or stem cell transplant in which someone receives bone marrow tissue orcells from a donor (called an allogeneic transplant). The new,…
The purpose of this study is to test a new medicine to prevent liver venoocclusive disease (VOD) in patients undergoing hematopoietic stem cell transplant (HSCT) who are at high risk or very high risk for liver VOD following HSCT. Liver VOD can be a complication of bone marrow and/or stem cell transplant,which may be life threatening. The condition is a…
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…
A Phase 2 Study of Atezolizumab (MPDL3280A) in Combination with Bevacizumab in Patients with Recurrent, Persistent or Metastatic Cervical Cancer. The purpose of this study is to test any good and bad effects of a combination of study drugs called atezolizumab and bevacizumab. The combination of atezolizumab and bevacizumab could shrink your cancer but it…
The purpose of this study is to test the safety of different doses of HCIG when given to patients with HCV who receive a liver transplant. It will also provide information about whether HCIG can prevent HCV infection. Participation in the study is expected to last about 10 months. Participants will be randomly assigned to either receive HCIG or not. Your…
Test the safety and effectiveness of the research study drug, pembrolizumab (MK-3475) in combination with chemotherapy, compared to chemotherapy plus placebo (a look-alike drug with no active ingredients) in women with persistent, recurrent, or metastatic cervical cancer. To test if adding pembrolizumab (MK-3475) to standard chemotherapy improves survival…
This study will only include women who have platinum sensitive relapsed epithelial ovarian cancer meaning your ovarian cancer did not return for at least 6 months after your first treatment with chemotherapy containing platinum (carboplatin or cisplatin). This research is being done to find out if carboplatin plus paclitaxel or carboplatin plus Pegylated…
The purpose of this study is to detect Bronchiolitis Obliterans Syndrome (BOS) at an early stage. Bronchiolitis Obliterans (BOS) is a form of chronic lung transplant dysfunction that affects many lung transplant recipients and can limit long-term survival. This study aims to increase the success rate of lung transplants by using advanced imaging tools to…
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 compare the effects of using Sodium Cridanimod in combination with the progestin (hormone therapy) megestrol acetate. Hormonal therapy on its own is generally not aneffective treatment for endometrial cancer when there are not have enough progestin receptors on tumor cells. The addition of the study drug Sodium Cridanimod…
The purpose of this study is to see which study drug is the better treatment for CMV infection. The study also wants to see how safe the study drugs are. The study drugs are Maribavir and Valganciclovir. Those who participate in the study will not know which drug they are taking. The study team will not know either.
The purpose of this study is to see if study drugs ABT-450/r/ABT-267, and ABT-333 taken with RBV are safe and able to reduce the amount of Hepatitis C Virus (HCV) in subjects' blood over a 24-week treatment period. These drugs are intended to prevent the HCV from multiplying in the human body. Subjects who participate in this study will be expected to…
HE4 (Human Epididymis Protein 4) is a biomarker expressed in the normal lining of the female genital tract and breast. We are doing this research study to if HE4 is an indicator of treatment response during initial therapy for Primary Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancers. For this we will collect blood at specific intervals.…
This study is for women with one of the following cancers, cancer of the ovary, fallopian tube or peritoneum and you had previous treatment with carboplatin or cisplatin. The purpose of this research study is to find a different treatment for platinum-resistant TP53-mutated high-grade serous (HGS) ovarian cancer patients. The investigational drug AZD1775 is…
The purpose of this study is to see if the study drug Harvoni given for 4 weeks immediately after liver transplantation is safe and able to clear the Hepatitis C virus (HCV) from the body. This study will test a drug named Harvoni for the treatment of chronic genotype 1 or 4 Hepatitis C Virus (HCV) in peri-operative liver transplant patients. Harvoni (LDV/…
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 LIGHT study is a clinical research study for women who have been diagnosed with ovarian cancer. The purpose of the study is to evaluate the safety and effectiveness of an investigational drug in women with this type of cancer, using genetic information to evaluate tumors.
In this trial, we will evaluate whether partially-HLA matched allogeneic multivirus-specific VSTs, will be safe and produce anti-viral effects in immunodeficient recipients infected with one of more of the targeted viruses that are persistent despite conventional anti-viral therapy. This will be in patients who have received a hematopoietic stem cell…
The purpose of this study is to determine if the administration of non-absorbable antibiotics (rifaximin) for the first three months after liver transplant period will reduce the amount of fibrosis (scarring of the liver) in liver transplant patients with hepatitis C virus (HCV) by lowering serum LPS (a protein in the blood that comes from the bacteria in…
The purpose of this study is to evaluate how accurately cells that are collected from the Fallopian tube can be categorized as benign or malignant. The MAKO 7 will be used to collect cell samples from the Fallopian tube. You are being asked to participate in the study because you are a woman who is undergoing a surgery to remove your Fallopian tubes and/or…
The purpose of this study is to find out if the study drug, HE4 has the potential to improve performance of biomarker CA 125 to determine recurrence of epithelial ovarian cancer before detecting the cancer clinically, surgically or through radiological scans. HE4 (Human Epididymis Protein 4) is a biomarker expressed in the normal lining of the female…
The purpose of this research study is to determine if PerClot is safe and effective to stop bleeding during surgery. PerClot is a medical device in granule form made from the starch of a potato. The starch has been engineered in a way that the powder absorbs water and helps to form a clot. This kind of device is intended for use in surgical procedures when…
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…
A single arm, open-label, Phase IIb study to assess the efficacy and safety of the combination of cediranib and olaparib tablets in women with recurrent platinum resistant epithelial ovarian cancer, including Fallopian tube and/or primary peritoneal cancer who do not carry a deleterious or suspected deleterious germline BRCA mutation. The purpose of the…
The primary objectives of this study are to measure the safety and effectiveness of bone marrow transplant (BMT) using specific chemotherapy in children with less severe SCD and to understand the long term effects of bone marrow transplant in children with SCD, by evaluating ovarian reserve, sickle cell related brain problems, sickle cell related kidney…
The purpose of this study is to evaluate the safety and efficacy of FS Grifols as an adjunct to hemostasis during parenchyomous tissue open surgical procedures. Baseline assessments will be performed within 24 hours prior to the scheduled surgery. There will be a physical assessment and a blood draw at the first study visit. Subjects will be randomly…
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 purpose of this study is to determine whether SPL-108 injection might be useful for the treatment of ovarian cancer. The study will evaluate whether SPL-108 can slow the growth and spread of cancerous cells in your body. If you agree, you will be treated with SPL-108 injection in combination with paclitaxel and we will collect blood and tissue samples…