This study is being done to learn more about the study drug known as AZD0780. AZD0780 is investigational meaning it has not yet been approved for commercial uses by the Food and Drug Administration (FDA) but has been approved for use in this study. This study will evaluate the efficacy, safety and tolerability of AZD0780. AZD0780 is taken once daily by mouth. This is a randomized study which means you will be assigned by chance, like flipping a coin, and you will have a 1 in 2 chance of being assigned to the study drug or placebo. Placebo is a substance that looks like the study drug but has no active ingredients. Neither you nor your study doctor or study team will know if you are assigned to study drug or placebo.
Participation in this study will last up to 4.5 years and include up to 15 visits. Study related procedures include medical history collection, physical exams, electrocardiogram (ECG – a test that records the heart's electrical activity), questionnaire and bloodwork. There are risks related to the study drug including increased blood pressure, shortness of breath and vomiting.
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 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 for patients who have non-small cell lung cancer that is stage IV or has returned after remission. The goal is to compare the usual treatment by itself to the usual treatment plus a drug called cemiplimab. "Investigational" means this drug combination has not been approved by the U.S. Food and Drug Administration (FDA). A computer will randomly assign patients to one of two groups. This process is called "randomization." Patients will be placed into a group by chance, like flipping a coin, and will have an equal chance of being in Group 1 or Group 2. The drug is given by infusion. Patients will keep getting treatment until the cancer gets worse. Each treatment cycle lasts 21 days. After the last cycle, patients will be followed for up to 3 years.
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 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 study is enrolling participants with risk factors for heart or blood vessel events (e.g. heart attack, stroke, etc) who also have an elevated lipoprotein a (Lp(a)), which is a sticky particle in the blood that carries cholesterol. The first part of the study involves testing the Lp(a) level and if elevated then participants will be invited to be a part of a study testing the investigational medication olpasiran. Investigational means it has not been approved for commercial use by the Food and Drug Administration. The study medication is given as a shot just under the skin every 3 months. This study is a randomized study meaning participants are assigned by chance to either receive olpasiran or placebo. Placebo looks like the real medication but has no active ingredients. Participants have a 50:50 chance of being assigned to either group but will not know which group they are in. Study related procedures include physical exams, blood work, vital signs, electrocardiogram (ECG - a tracing of the heart's electrical activity) and study medication administration. This study is expected to last about three and a half to five and a half years and involve between 16 to 28 visits.
This study is an open label extension of the ACT-EARLY study. which included those with no evidence of ATTR but are known carriers of disease causing TTR gene. ATTR stands for transthyretin amyloidosis. It is a condition in which a protein called transthyretin (TTR) accumulates in various organs, including the heart (known as ATTR-CM), kidneys, and nerves (known as ATTR-PN). This accumulation can lead to damage and dysfunction in these organs.
This study will continue using the study drug acoramidis (AG-10) to determine if it can help people with the genetic TTR variant slow the progression of ATTR. AG-10 is an investigational drug. Investigational means that AG-10 is not yet approved for use in any settings outside of clinical research studies like this one. Reducing the amount of TTR in your blood may reduce the amount of amyloid deposits in your body and may keep your cardiomyopathy from getting worse over time.
Participation in this study will last up to 60 month and will consist of about 13 clinic visits and about 11 telephone follow up visits. Some tests required include physical exams, medical and surgical history, bloodwork, questionnaire, electrocardiogram (test that records your heart's electrical activity), echocardiogram (ultrasound test of your heart) and study drug administration.
The purpose of this study is to test whether adding cetuximab to standard of care (pembrolizumab) is more effective in shrinking tumor size and increasing survival when compared to being treated with pembrolizumab alone. This study seeks to find if this approach is the same, better, or worse than standard of care for returning or spreading head and neck cancer after previous treatment.
Treatment and follow up for this study may be up to 5 years. The procedures include blood tests, CT or MRI scans, and chemotherapy. Risks include tiredness, anemia, constipation, loss of appetite, joint stiffness, cough, swelling and redness of the skin.
You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future. Both drugs, pembrolizumab and cetuximab, are already individually approved by the FDA for use in head and neck cancers. However, the benefit of combining the two drugs is being investigated in this study and this study approach is not FDA approved.
There will be about 158 people taking part in this study, approximately 4 subjects will be enrolled at MUSC.
This study is for subjects who have been diagnosed with recurrent or metastatic nasopharyngeal cancer. Subjects are expected to remain in the study for a minimum of 70 months. Drugs are FDA approved and is given through a vein (also called IV or intravenous). The procedures include blood and urine tests, troponin test. Risks include infection, bruising, bleeding, anemia, kidney damage, hearing loss, nausea, vomiting, numbness, pain, rash, blood in urine. You may not receive a benefit from participating in this trial, however, information learned from the trial may help other people in the future.