This study is for subjects who have been diagnosed with acute leukemia or myelodysplastic syndrome (MDS) and are a candidate for allogeneic hematopoietic stem cell transplant (HSCT). The study is being done to learn if adding defibrotide to the standard medicines for prevention of acute Graft-versus-Host Disease (aGvHD), which is called immunoprophylaxis, will help to prevent aGvHD better than using the usual immunoprophylaxis medicines alone. The investigational drug in this study is called Defibrotide. The duration of participation for each patient is approximately 6 months.
This study is for patients who have been diagnosed with acute myeloid leukemia (AML) with a genetic mutation called FLT3/ITD. The investigational drug in this study is called gilteritinib (ASP2215). The main purpose of this study is to learn if it is safe and effective to treat patients who have FLT3/ITD AML with a study drug called gilteritinib (ASP2215) after transplant. The sponsor wants to know if this drug works better than a placebo to stop the AML from coming back. Participants can expect to be in this study for up to 7 years after they start the study drug.
It is important to understand multiple personal-level factors that impact disease risks and outcomes to determine the most effective ways to establish precise medical strategies to prevent, diagnose, and treat chronic health conditions and diseases. This is especially important among minority and underserved populations that would benefit from more tailored healthcare approaches. This study will develop and assess strategies for circulating evidence about precision medicine and improving precision medicine approaches.
This is a study that will test how an experimental drug (enfortumab vedotin) combined with a kind of anticancer drug called an immune checkpoint inhibitor (CPI) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body.
The purpose of this first in human study is to find a safe dose level of the investigational drug REGN3767 alone or in combination with REGN2810. Other purposes of this study are to measure the levels of REGN3767 and REGN2810 in the subject's blood and to collect any evidence of tumor shrinkage when given alone or in combination with REGN2810.
REGN3767 and REGN2810 are both a type of drug called a monoclonal antibody. Antibodies are proteins that are naturally found in your blood stream that fight infections. A monoclonal antibody is a special kind of antibody that is manufactured as a medication to target a specific protein in the body that may be involved in the subject's cancer.
In this part of the study each participant will receive 1 of 3 different doses of REGN3767 alone or in combination with one dose of REGN2810. There will be a total of 6 different groups of participants the study team plans to study based on what dose of REGN3767 they receive and whether they receive it alone or with REGN2810.
The study is sponsored by Regeneron. The investigator in charge of this study at MUSC is Carolyn Britten, MD. Part 1 of this study is being done at 4-5 sites. Approximately24-48 people will take part study-wide.
The purpose of this study is to study test investigational drugs PEGPH20 and Atezolizumab in combination with the current standard of care medications Cisplatin and Gemcitabine.
Subjects are being asked to participate in this study because they are/have intrahepatic and extra hepatic cholangiocarcinoma or gallbladder adenocarcinoma which are types of cancers associated with the liver or biliary system. The study is sponsored by Halozyme.
This study involves the adiminstration of an invetigational drug (not approved by the FDA) PEGPH20 in order to determine what a safe dose is when given with Cisplatin and Gemcitabine, what the side effects are, and whether or not it will help treat the kind of cancer you have. PEGPH20 is an enzyme (protein that can speed biochemical reactions) that breaks down a specific substance called hyaluronan produced by some tumors. The removal of hyaluronan from tumors has been shown to inhibit tumor growth.
Atezolizumab is an immunotherapy drug which means it assists your immune system in fighting your cancer. This drug has been approved by the United States Food and Drug Administration (FDA) to treat bladder and lung cancer, but is investigational with the drugs described above and for the diagnosis of intrahepatic and extra hepatic cholangiocarcinoma or gallbladder adenocarcinoma . The other therapy that is given in this study is standard of care chemotherapy drugs Cisplatin and Gemcitabine, which are drugs that are routinely given to treat patients with cholangiocarcinoma or gallbladder adenocarcinoma cancers who are not in research studies.
The investigator in charge of this study at MUSC is Dr. Carolyn Britten. Approximately 70 subjects will take part study wide at about 20 centers in the United States and 10 centers in Asia. Halozyme will be providing funding to MUSC and Dr. Britten for conducting this research.
The purpose of this study to learn more about a new experimental drug called TSR-022 and its effect on the subject's cancer when used either alone or with another experimental drug called TSR-042. TSR-022 is considered investigational, which means that TSR-022 alone or in combination with TSR-042 has not been approved by any regulatory authorities, including the United States Food and Drug Administration (FDA), and is not available in stores or by prescription.
The main purposes of Part 2 are to:
Look at the ability of TSR-022 when taken alone or in combination with TSR-042 to make the cancer smaller
Confirm the recommended phase 2 dose and dosing schedule of TSR-022 when taken by itself
Confirm the recommended phase 2 dose and dosing schedule of TSR-022 when taken with TSR-042 as Combination Therapy.
This study will enroll patients with advanced melanoma, advanced colorectal cancer and advanced non-small cell lung cancer (NSCLC).
The purpose of this study is to determine if giving the medicine "heparin" intravenously (through the veins) continuously for up to 14 days to subjects after a brain aneurysm has burst will help improve the chances of subjects having a good recovery after the bleed compared to subjects who get routine brain aneurysm care (standard of care). Patients who get routine care would also get heparin, but they would typically get an overall lower dose and the heparin would be injected under the skin (heparin shot) instead of in the veins.
This study is for patients who have been diagnosed with advanced or metastatic non-small cell lung cancer (NSCLC) whose disease improved or remained unchanged after receiving nivolumab or pembrolizumab and whose disease has now worsened. The investigational drug in this study is called ALT-803. Participants can expect to receive the study drug ALT-803 in combination with an approved drug called pembrolizumab or they will receive ALT-803 in combination with an approved drug called nivolumab. Participants will receive ALT-803 in combination with pembrolizumab if they have previously received pembrolizumab. They will receive ALT-803 in combination with nivolumab if they have previously received nivolumab. The purpose of this research study is to test the effectiveness of the study drug, ALT-803, in combination with either pembrolizumab or nivolumab in patients with advanced or metastatic NSCLC that initially had improvement or no change in disease after receiving pembrolizumab or nivolumab and who now have disease worsening. Participation in this study should take approximately 24 months.
This study is for patients that have been diagnosed with a type of cancer called Acute Myeloid Leukemia (AML). The investigational drug in this study is ONO-7475. The purpose of this study is to see whether ONO-7475 slows down the growth of cells that cause cancers like leukemias such as AML. The estimated duration of study participation in Part A is 6 months. You can continue in the study as long as you are gaining benefit from the study treatment.