Clinical trials located in

Napoli

Napoli city is located in Italy. Currently, 16 clinical trials are being conducted in this city.

  • CT-EU-00117988

    Baricitinib study in children with juvenile idiopathic arthritis

    This clinical trial is designed to test whether Baricitinib is safe and effective in the treatment of systemic juvenile idiopathic arthritis in children aged 1 to 18 years. Participants will be assigned to one of two groups. In the first group, some participants will receive Baricitinib and others Tocilizumab as the reference drug. In the second group, all participants will receive Baricitinib.

    The primary objective of the study is to evaluate the percentage of participants who experience at least a 30% improvement in disease symptoms after 12 weeks of treatment according to the modified American College of Rheumatology Pediatric Response Criteria (PediACR30). Baricitinib is administered orally and Tocilizumab is administered by subcutaneous injection.

    • Tocilizumab
    • baricitinib
  • Study of Pembrolizumab/Quavonlimab Combination vs Other Treatments for Colorectal Cancer

    This here clinical trial is aimin’ to take a good look at a new combination treatment called co-formulated pembrolizumab/quavonlimab for folks with stage IV colorectal cancer that’s got that microsatellite instability-high or mismatch repair deficient business goin’ on. The main goal is to see how well this new combo treatment works at shrinkin’ them tumors, compared to some other treatments out there.

    Now, the real important part is that the doctors’ll be keepin’ a close eye on how many folks get what they call an objective response, meanin’ their tumors either disappear completely or shrink down by at least 30%. They’ll be trackin’ this over a span of up to around 50 months to get a good picture of how effective this new treatment is.

    Safety’s always a top priority too, so the doctors’ll be watchin’ out for any side effects or issues that might crop up with this new combo treatment. It’s all about findin’ the best way to fight that cancer while keepin’ folks as comfortable as possible.

  • Study ANV419 as monotherapy or in combination with pembrolizumab and ipilimumab in patients with metastatic melanoma

    The aim of this study is to test a new drug called ANV419. It will be given alone or in combination with other approved cancer medicines such as pembrolizumab or ipilimumab. The main goal is to see how well ANV419 works and whether it is safe for people with advanced cutaneous melanoma, which is a type of skin cancer that has spread or cannot be surgically removed.

    The trial is currently open to adult patients who have already been treated with drugs that target PD-1 or PD-L1 proteins, but whose cancer has continued to progress. The study will have different parts. First, doctors will find the right dose of ANV419 to use alone or in combination with other treatments. They will then check how many patients respond to treatment, which means their tumors shrink or stop spreading.

    • ANV419
    • Ipilimumab
    • Pembrolizumab
  • To evaluate a combination of 3 different drugs versus 2 other drugs in the treatment of patients with melanoma

    This study compares two different approaches to treating advanced melanoma, a type of skin cancer that has spread to other parts of the body. This study is specifically aimed at patients with a gene mutation called BRAF who have previously received treatment with drugs such as nivolumab or pembrolizumab.

    One therapeutic approach involves taking three study drugs: pembrolizumab administered intravenously every 3 weeks, along with encorafenib and binimetinib taken orally daily at home. The second approach involves taking two study drugs: ipilimumab and nivolumab administered intravenously every 3 weeks for the first 4 doses, followed by nivolumab alone every 4 weeks. Both treatments will last for approximately 2 years, but there is no time limit for treatment with encorafenib and binimetinib.

    The research team will closely monitor the patients’ health during regular clinic visits to see how they are responding to treatment. The main goal is to determine which treatment method is more effective in shrinking or eliminating melanoma tumors.

    • Nivolumab
    • Ipilimumab
    • Binimetinib
    • Encorafenib
    • Pembrolizumab
  • A study comparing biosimilar nivolumab and nivolumab in the treatment of resected melanoma

    The aim of this study is to test whether a new drug called ABP 206 (biosimilar nivolumab) works as well as the approved cancer drug OPDIVO® (nivolumab) in people with advanced cutaneous melanoma that has been surgically removed. The study divided people into 3 groups: one group will receive ABP 206, the second will receive real OPDIVO® approved in the US, and the third will receive the version of OPDIVO® approved in Europe. All of these medicines will be given through an intravenous drip every 4 weeks for up to 1 year, or until the cancer comes back or gets significantly worse.

    The main goal is to check whether ABP 206 (biosimilar nivolumab) is absorbed and maintained in the body in the same way as OPDIVO®. Researchers will also closely monitor how well it works, what the side effects are, and whether the body produces antibodies against it. The entire study will last approximately 13 months for each person joining.

    • Nivolumab biosimilar
    • Nivolumab
  • Study of DYP688 in patients with metastatic uveal melanoma

    The aim of this study is to test a new drug combination to treat metastatic uveal melanoma, a type of cancer that starts in the eye and spreads to other parts of the body. The main drugs being tested are IDE196 (also called darovasertib) and crizotinib, both taken by mouth twice daily.

    Currently, this process is divided into several stages. In the first part, investigators will test two different doses of IDE196 in combination with crizotinib and compare them to other approved therapies such as pembrolizumab, ipilimumab + nivolumab, or dacarbazine. Once they determine the best dose of IDE196, they will move to the next step in which everyone will receive that dose along with crizotinib or one of the other treatments.

    Researchers will primarily look at how long the cancer stays under control without getting worse and how long patients live. It could take about 4 years to get all the answers you need.

    • Darovasertib/IDE196
    • Dacarbazine
    • Nivolumab
    • Crizotinib
    • Ipilimumab
    • Pembrolizumab
  • Study assessing the effectiveness of Tebentafusp administered alone and in combination with Pembrolizumab in the treatment of advanced melanoma

    The aim of this study is to test new treatments for people with advanced skin melanoma that does not respond well to other therapies. The main focus was on a new experimental drug called tebentafusp, which is a special type of protein that helps the body’s immune system recognize and attack cancer cells.

    The study divided patients into three different groups. One group will receive tebentafusp alone. Another group will receive tebentafusp in combination with another immunotherapy drug called pembrolizumab. The third group will receive the treatment that the doctor thinks is best for the patient – this could be another experimental drug, standard therapy, or simply supportive care.

    Scientists are primarily focusing on the effectiveness of these treatments in shrinking tumors and extending patient survival. They will also monitor closely for any side effects to make sure the treatment is safe. The study is expected to last about two years and will include frequent check-ins to monitor patient responses.

    • Tebentafusp
    • Pembrolizumab
  • To evaluate the effectiveness of nivolumab used alone and in combination with HBI-8000 in the treatment of unresectable or metastatic melanoma

    This is a study comparing two treatment options for patients with melanoma that cannot be surgically removed or has spread to other parts of the body. One treatment option is an investigational drug called Tucidinostat (HBI-8000) taken by mouth twice a week in combination with an approved drug called nivolumab given by intravenous infusion. Another option is a placebo taken orally twice a week, also in combination with nivolumab given by intravenous infusion.

    The primary goal of the study is to determine whether the combination of HBI-8000 and nivolumab is more effective than nivolumab alone in shrinking the tumor or preventing further tumor progression. The study will also assess the safety of the treatment combinations.

    Patients enrolled in the main study will be randomly assigned to receive either the HBI-8000 combination or a placebo combination. Treatment will continue for up to 2 years or until the cancer progresses, side effects worsen or the patient decides to withdraw from the study. The study will last up to 4 years and will include regular monitoring and follow-up visits.

    • Placebo
    • Tudicdinostat/HBI-8000
  • Safety and efficacy of pembrolizumab in combination with investigational drugs in the first-line treatment of patients with melanoma

    The aim of this study is to test new experimental treatments for melanoma, which is a type of skin cancer. The main goal is to test whether these new treatments are safe and effective when used alone or in combination with the drug pembrolizumab.

    The current study includes several different treatment groups. Some groups receive pembrolizumab in combination with other investigational drugs such as vibostolimab, quavonlimab, lenvatinib, favezelimab, or Tretynoina (ATRA). Other groups simply receive pembrolizumab alone.

    Scientists will carefully look at factors such as dose-limiting toxicities and adverse events to make sure the treatment is safe. They will also check the effectiveness of the therapy by measuring, for example, the objective response rate, which shows whether tumors are shrinking or disappearing.

    • Tretynoina
    • Vibostolimab
    • Quavonlimab
    • Favezelimab
    • Pembrolizumab
    • Lenvatinib
  • Study on combining two drugs – Fianlimab and Cemiplimab in patients with previously untreated melanoma

    This study examines two drugs, fianlimab and cemiplimab, given together for the treatment of melanoma. The main goal is to see how effective this drug combination is in treating melanoma compared with pembrolizumab, which is already approved for the treatment of melanoma in adults. The study will also look at whether there are any differences in the effects of these experimental drugs in adolescents and adults.

    Scientists also want to learn about other key issues: what side effects may occur from taking these experimental drugs, how much of the drugs enter the bloodstream over time, and whether the body produces antibodies to the drugs that could make them less effective or cause side effects. They will also check whether taking medications improves patients’ quality of life. Fianlimab and cemiplimab will be administered by intravenous infusion, and pembrolizumab will be administered by intravenous infusion.

    • placebo
    • Fianlimab
    • Cemiplimab
    • Pembrolizumab
  • Study of the drug combination mRNA-4157/V940 and Pembrolizumab in the treatment of melanoma

    The aim of this clinical trial is to test whether a new drug called mRNA-4157/V940 in combination with pembrolizumab can help prevent the recurrence of melanoma in people who have already had it. Currently, mRNA-4157/V940 is what is called “individualized neoantigen therapy,” which means it is a therapy created specifically for each patient based on their cancer cells. Doctors give this drug along with pembrolizumab, a drug that helps the immune system fight cancer cells.

    The main goal of this study is to determine whether taking V940 and pembrolizumab together is more effective in preventing melanoma recurrence than taking pembrolizumab alone. Researchers will closely monitor how long it takes for the cancer to return or spread. The study will last for approximately 74 months.

    • mRNA-4157/V940
    • placebo
    • Pembrolizumab
  • Comparison of zibotentan/dapagliflozin with dapagliflozin alone in the treatment of chronic kidney disease with high proteinuria

    The study aims to understand how to better treat people with chronic kidney disease (CKD) and high proteinuria. This study is in its third phase and involves multiple centers where participants will be closely monitored. The main goal is to compare the effectiveness, safety, and how well participants tolerate a combination treatment of zibotentan/dapagliflozin versus dapagliflozin alone.

    During this study, participants will be randomly assigned to one of two groups. One group will receive the combination of zibotentan and dapagliflozin, while the other group will receive only dapagliflozin. Both treatments aim to slow down the decline in kidney function, which is a major concern for people with CKD and high proteinuria. The key measure of success for this study is the change in eGFR from baseline, which is a test used to check how well the kidneys are working, specifically by measuring the estimated glomerular filtration rate (eGFR). This will be assessed at the 24-month mark of the study.

    This research is crucial because it could lead to better treatment options for those suffering from CKD and high proteinuria, potentially improving their quality of life and health outcomes.

    • Zibotentan/Dapagliflozin
    • Dapagliflozin
  • ARTEMIS study: Protecting kidney health in heart surgery patients with Ravulizumab

    The ARTEMIS study aims to find a new way to protect people with chronic kidney disease (CKD) undergoing heart surgery requiring the use of a heart-lung machine, also known as cardiopulmonary bypass (CPB). The main aim of this study is to see if a single dose of a drug called ravulizumab given intravenously can reduce the risk of serious kidney problems after surgery, compared with a placebo. Kidney issues are grouped under serious adverse events, and investigators will monitor them for up to 90 days after surgery. The study is carefully controlled and participants will not know whether they are receiving ravulizumab or a placebo to ensure the results are unbiased. This is an important test for people with chronic kidney disease undergoing heart surgery because it may lead to better outcomes and a lower risk of kidney damage after surgery.

    • placebo
    • Ravulizumab
  • Study on CRN04894 for congenital adrenal hyperplasia safety and effectiveness

    The study is designed to explore the effects of a new medication called CRN04894 on individuals who have a condition known as classic congenital adrenal hyperplasia (CAH), which is caused by a deficiency in the enzyme 21-hydroxylase. This condition affects the adrenal glands and can lead to various health issues. The main goal of this study is to understand how safe and effective CRN04894 is for people with CAH, as well as to learn how the body processes the medication.

    CRN04894 is a unique medication that is taken orally and works by blocking certain receptors in the body related to the production of adrenal hormones. By participating in this study, individuals will receive this medication for 12 weeks. During this time, researchers will closely monitor participants to see how well the medication works in reducing levels of a hormone called androstenedione, which is often elevated in people with CAH. Additionally, the study will keep track of any side effects that participants may experience to ensure the medication is safe to use.

    • CRN04894
  • A study of relacorilant in the treatment of hypercortisolism (Cushing’s syndrome) in patients with adrenal adenoma

    This clinical trial focuses on testing the effectiveness and safety of a drug called relacorilant in the treatment of patients with hypercortisolism (Cushing’s syndrome). Hypercortisolism is a condition in which there is too much cortisol in the body, which may occur due to an adenoma or hyperplasia of the adrenal glands that secrete cortisol. This condition can lead to diabetes or impaired glucose tolerance and/or uncontrolled high blood pressure.

    The study is in phase III, which means that the effectiveness and safety of the drug are compared with placebo. This is a double-blind, placebo-controlled study, which means neither participants nor researchers know who is receiving the actual drug and who is receiving the placebo to ensure unbiased results.

    Participants in this study will be randomly assigned to receive relacorilant or placebo for 22 weeks. The main goals of the study are to see how well relakorilant can improve blood sugar levels in patients with diabetes or impaired glucose tolerance, and how it affects blood pressure in people with high blood pressure. Additionally, the study will monitor the safety of relacorilant by recording any adverse events that occur.

    People who complete the study may have the opportunity to continue with a follow-up study, which may provide further information on the long-term effects and benefits of relacorilant.

    • Relacorilant

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