This phase 3 study is recruiting patients who are at risk of graft-versus-host disease (GVHD) after a bone marrow transplant. This study will measure the safety and effectiveness of a prevention treatment combination called Tacrolimus/Methotrexate/Ruxolitinib compared to Standard of Care (SOC), Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil. Ruxolitinib (Rux) is an approved treatment for GVHD. This study is divided into two parts. The first part, called the run-in phase, will investigate the best dose of Ruxolitinib. The second part of the study will compare the SOC combination therapy with the investigational combination therapy (which will include Ruxolitinib). Participants will be randomly assigned to one of the two groups (like flipping a coin). The study will enroll up to 572 patients nationwide and 5 at MUSC. The participants can expect to be involved in the study for at least 24 months. The main risk is that medical treatments often cause side effects. The most common side effects expected from the investigational combination therapy are high cholesterol, increased liver enzymes, low platelet levels, and low red blood cell counts. There is no direct benefit for them in participating in this study.
This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach.
This study is for patients that have been diagnosed with non-small cell lung cancer (NSCLC). This study is testing an investigational drug called Amivantamab. "Investigational" means that is not been approved by United States Food and Drug Administration (FDA). There will be no randomization in this study. Participants will be assigned to treatment upon enrollment based on disease treatment status. The primary purpose of this study is to understand how well the study treatment works and the safety of the combination of Amivantamab and Lazertinib in participants who have NSCLC with a specific eGFR mutation. Amivantamab can be given under the skin (subcutaneous) or by infusion (IV). Participants can be in the study for up to 36 months depending on how the participants disease responds to treatment.
This is a Phase II clinical trial testing a drug called Telisotuzumab Vedotin in people who have already been treated for a specific type of lung cancer that has spread or is hard to remove with surgery. The cancer must show high levels of a protein called c-Met and have a normal version of another protein called eGFR. The main goal is to see how well the drug works and how safe it is when given in three different ways. Telisotuzumab Vedotin is a special kind of medicine that combines an antibody (which targets cancer cells) with chemotherapy. It's given through an IV (a tube in your vein), and each treatment takes about 30 minutes. Patients will get this treatment every two weeks on day one of the cycle. There will be four cycles in the study. There is also a 28 day screening window, a 30 day follow up period, post treatment follow up, and then survival follow up. The study itself will only last a few months, but the follow up will last for years. The follow up period will have limited contact compared to the main study. There will be around about 10 total study visits.
This phase II trial tests how well biomarker tests on patients tumor tissue works in selecting personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). This study also tests different types of maintenance treatment for ES-SCLC with drugs durvalumab, saruparib, ceralasertib or monalizumab. Maintenance treatment is given after initial treatment and is given to help keep the cancer under control and prevent it from getting worse. Immunotherapy with monoclonal antibodies, such as durvalumab and monalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Saruparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Ceralasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for tumor cell growth. Giving biomarker selected personalized maintenance treatment with durvalumab, saruparib, ceralasertib or monalizumab may work better in treating patients with ES-SCLC.
This is a clinical use of an FDA-approved Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE) called Miltenyi Biotec CliniMACS CD34. The intent is to treat patients with Myelodysplastic Syndrome (MDS) in a clinical setting, not to conduct research or gather data on safety or effectiveness. No data will be collected beyond what is required for standard clinical care. Device-related processing will occur at an NMDP Advanced Cell Therapy Lab Solutions facility, and the resulting cell product will be transported to MUSC Hollings Cancer Center for infusion. Eligible patients are in first complete remission and undergoing allogeneic stem cell transplant (SCT) from an HLA-identical matched related donor. Patients will be provided MUSC's standard treatment consent per institutional policies. The HUD will be stored, dispensed, and used at NMDP in accordance with standard operating procedures.
This study is testing a new medicine called Visugromab (CTL-002) to see if it helps people with a type of lung cancer called metastatic non-squamous non-small cell lung cancer. Everyone in the study will get standard cancer treatment, but some will also get Visugromab while others get a placebo (a look-alike with no active drug), and who gets what is decided randomly—like flipping a coin. The goal is to find out if Visugromab makes the treatment more effective and safe. The study will last up to two years, with Treatment in cycles lasting 3 weeks, about once a month. Researchers will closely monitor participants to see how well the treatment works and how their bodies respond. Serious risks of treatment may include heart problems, low oxygen levels, infections, organ failure, and inflammation in various parts of the body such as the lungs, liver, intestines, pancreas, and thyroid.
This research study is testing how well a combination of investigational drugs—N-803 and Tislelizumab with Docetaxel—works compared to Docetaxel alone in treating advanced non-small cell lung cancer (NSCLC). The drugs being studied are not yet approved by the FDA. Participants will be randomly assigned to one of two groups (like flipping a coin): the experimental group (receiving the drug combination) or the control group (receiving Docetaxel alone). For every 3 people, 2 will be randomized to the experimental group. You are being asked to join because your cancer has progressed after standard treatment and has become resistant to immune checkpoint inhibitors. Clinic visits will last about 3 to 4 hours and include routine tests and procedures. Treatment will continue until your cancer worsens, you experience severe side effects, choose to stop, or your doctor decides it's best to end treatment. After treatment ends, you'll have a follow-up visit and then be contacted every 3 months for up to 36 months to check on your health, either in person or via telemedicine. N-803 may cause side effects such as fever, high blood pressure, fatigue, itching, diarrhea, nausea, injection site reactions.
This study is for participants that have been diagnosed with Intermediate or High-risk Primary or Secondary Myelofibrosis. This study is testing an investigational drug called Nuvisertib. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The main purpose of this study is to evaluate the efficacy and safety of Nuvisertib. Nuvisertib is an oral PIM1 selective inhibitor. A PIM1 selective inhibitor is a drug that specifically targets and blocks the activity of the PIM-1 kinase, an enzyme implicated in cancer cell growth. This drug is given to participants by mouth. Participants in this study can expect to be in the treatment phase of this study for 19 months and the long term follow up phase for 3 years.
This study is for participants with symptoms of mast cell activation (SMAC). The primary purpose of this study is to learn about clonal mast cell diseases. Clonal mast cell diseases are hard to diagnose because symptoms are not specific, and they can overlap with other diseases. The tools currently used by doctors to look for clonal mast cell diseases in the blood may not identify all patients. This study is being done to develop an investigational blood test that looks for a change in a gene called KIT. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). Two types of blood tests will be compared against each other. Participants in this study can expect to be in this study for about 6 months.