Country: Belgium

Currently showing 20 clinical trials. Use pagination links to see more trials.

  • CT-EU-00117565

    Personalized T-cell therapy (NEO-PTC-01) for the treatment of patients with unresectable melanoma or metastatic melanoma

    This clinical trial aims to investigate the safety and activity of NEO-PTC-01, which is an autologous personalized T-cell (PTC) product for adoptive cell therapy. Adoptive cell therapy is a type of immunotherapy that uses cells from a patient’s immune system to fight diseases such as cancer. This therapy involves isolating, modifying and multiplying specific immune cells and then administering them to the patient. NEO-PTC-01 is produced outside the body and targets neoantigens displayed on and within the patient’s tumor.

    The study will be conducted in two parts: Part 1 (dose finding) and Part 2 (dose expansion). Two doses of NEO-PTC-01 will be tested in the dose finding portion. Additionally, interleukin (IL)-2 administration and anti-PD-1 antibody therapy are planned.

    Researchers will primarily observe how many patients experience any side effects or adverse events, whether they are mild or serious. To ensure patient safety, they will be under constant care of specialists.

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  • Study of an experimental drug TL-895 for myelofibrosis or indolent systemic mastocytosis

    This here clinical trial is studying a new experimental drug called TL-895. TL-895 is taken by mouth and works by blocking certain proteins called tyrosine kinases that are involved in causing myelofibrosis and indolent systemic mastocytosis.

    Participants in the study will receive TL-895 orally in varying doses based on their specific group assignment. These doses range from 150 mg to 450 mg, and the administration could be either once or twice daily, continuing in a consistent 28-day cycle. The primary goal of the study is to determine the recommended phase 2 dose (RP2D) for TL-895 in each patient group based on safety and tolerability data. Additionally, the study aims to assess the effectiveness of TL-895 in reducing spleen volume and improving symptoms associated with Myelofibrosis over a 24-week period.

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  • Study of Fidrisertib/IPN60130 in the treatment of Fibrodysplasia Ossificans Progressiva (FOP)

    The aim of this study is to test a new drug called fidrisertib (also known as IPN60130) to treat a rare disease called Fibrodysplasia Ossificans Progressiva, or FOP. FOP is a grave disease that causes bones to start growing in places they shouldn’t, such as muscles and soft tissues. This causes a lot of pain, swelling, and stiffness in the joints, making movement difficult.

    In the study, some participants will be given the new drug fidrisertib at two different doses, and others will be given a dummy treatment called a placebo. Researchers will monitor the situation closely, performing special tests called low-dose whole-body computed tomography (WBCT) to measure new bone growth. For some older participants, they may also use another type of test called fluorine-18-labeled sodium fluoride positron emission tomography – computed tomography to check bone growth.

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  • 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.

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  • 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.

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  • NCT05608291

    This here clinical trial, folks, is aimin’ to see if a new combination of drugs called fianlimab and cemiplimab works better than a drug called pembrolizumab at preventin’ or delayin’ that darn melanoma cancer from comin’ back after it’s been removed with surgery. Now, pembrolizumab is already approved for this purpose in some countries, but these researchers reckon this new combo might just do an even better job.

    The main goal is to see if this fianlimab and cemiplimab combo is an effective treatment compared to pembrolizumab for folks who’ve had their melanoma removed but are still at high risk of it comin’ back. But they’re also gonna be keepin’ an eye out for any side effects from these new drugs, how much of the drugs are in the blood at different times, and whether the body makes antibodies against ’em, which could make ’em less effective or cause side effects.

    They’re even gonna look at how takin’ these drugs might improve a person’s quality of life. So if you’re interested in joinin’ this trial, you’d be helpin’ to find out if this new combo is the bee’s knees for keepin’ that darn melanoma from comin’ back and botherin’ ya again.

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  • 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.

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  • 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.

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  • 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.

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  • Efficacy and safety study of rosnilimab in moderate to severe rheumatoid arthritis

    This study will evaluate the effectiveness and safety of Rosnilimab in patients with moderate to severe rheumatoid arthritis. Rosnilimab is an antibody that activates the PD-1 receptor, also known as ANB030. Patients will be randomly assigned to receive Rosnilimab or placebo.

    The main aim of the study is to assess changes in the 28-Joint Disease Activity Index based on the concentration of C-reactive protein (DAS28-CRP) after 12 weeks of treatment. DAS28-CRP is a validated tool that assesses disease activity based on the number of painful and swollen joints and the concentration of C-reactive protein in the blood. A reduction in DAS28-CRP indicates an improvement in the patient’s condition.

    This study aims to test whether Rosnilimab is effective and safe in the treatment of rheumatoid arthritis. If the results are promising, this drug could become a new treatment option for patients suffering from this disease.

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  • A study comparing upadacitinib versus adalimumab in the treatment of rheumatoid arthritis

    This clinical trial is studying a new medication called upadacitinib for treating moderate to severe rheumatoid arthritis. Rheumatoid arthritis is a chronic condition that causes pain, stiffness, swelling, and loss of joint function. The study will compare upadacitinib, which is taken as an oral tablet once daily, to adalimumab (brand name Humira), which is an injection given under the skin every other week.

    The main goal is to see how effective upadacitinib is at reducing disease activity compared to adalimumab. The study will measure the percentage of participants who achieve a certain level of low disease activity based on a score called the DAS28-CRP, which looks at tender and swollen joints, overall disease activity, and inflammation levels.

    This is a double-blind study, meaning neither the participants nor the study doctors will know which treatment each participant is receiving. Participants will attend regular visits at a hospital or clinic for medical assessments, checking for side effects, and completing questionnaires. There may be a higher treatment burden compared to standard care. The study is designed to assess the safety and effectiveness of upadacitinib compared to adalimumab in treating moderate to severe rheumatoid arthritis.

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  • Long-term safety study of efgartigimod in the treatment of primary Sjögren’s syndrome

    The study focuses on examining the medication efgartigimod and its potential to assist adults with Primary Sjögren’s Syndrome (pSS). Participants who have taken part in previous efgartigimod studies may qualify for this extension study. The primary aim is to assess the long-term safety of efgartigimod for individuals with pSS.

    During the 48-week duration of the study, participants will receive efgartigimod treatment. It’s important to understand that individuals from both the active and placebo groups of previous studies can participate, but they will not be informed of their previous group assignment. The researchers will closely monitor any side effects, including serious ones, as well as any changes in participants’ laboratory test results or vital signs throughout the study.

    This study offers an opportunity to further investigate the potential benefits of efgartigimod in managing pSS, particularly in reducing IgG autoantibodies, which are thought to contribute to the disease. Participation in the study could provide valuable insights into the long-term safety of this treatment.

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  • Study on the effectiveness of Givinostat in Non-Walking Duchenne Muscular Dystrophy Patients

    This clinical trial is focused on testing the effectiveness, safety, and how well patients can tolerate a medication called Givinostat for those who have Duchenne Muscular Dystrophy (DMD) and can no longer walk. The study is designed for male pediatric patients aged between 9 to less than 18 years. A total of 138 participants will be involved, and they will be divided into two groups. One group will receive Givinostat, and the other group will receive a placebo, which is a substance with no therapeutic effect, designed to mimic Givinostat. This division will be done randomly and both the patients and the doctors will not know who is receiving the actual medication and who is receiving the placebo, making this a double-blind study.

    The main goal of this study is to see if Givinostat can help reduce muscle decline in patients with DMD who cannot walk, by looking at changes in upper limb function after 18 months of treatment. The safety and tolerability of Givinostat in these patients will also be closely monitored.

    Participants will be involved in the study for about 20 to 21 months, which includes a 4-week screening period to confirm eligibility, 18 months of treatment, and a follow-up period. At the end of the treatment period, all participants, regardless of which group they were in, will have the option to join a long-term safety study where they will receive Givinostat.

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  • Understanding the Impact of Antiphospholipid Antibodies on Vascular Health in Chronic Kidney Disease Patients

    This clinical trial is focused on understanding how a condition known as endothelial dysfunction, which affects the blood vessels, is influenced by antiphospholipid antibodies in patients undergoing hemodialysis due to chronic renal failure. The study aims to explore the connection between these antibodies, the health of blood vessels, and complications related to arteriovenous fistula—a common vascular access for hemodialysis patients.

    To assess the health of your blood vessels, we use a non-invasive test called the “Flow Mediated Dilation” (FMD) test. This test measures how well your blood vessels can expand in response to increased blood flow, which is an indicator of their health. The study will also look into various factors that might affect the health of your blood vessels, including the levels of certain substances in your blood and urine, such as nitric oxide and endothelin, which play roles in blood vessel function.

    By participating, you’ll contribute to research that could help improve the understanding of how chronic kidney disease and hemodialysis affect blood vessel health, potentially leading to better management of vascular access and reducing complications. This study is especially relevant if you’re undergoing hemodialysis and are interested in how your condition might be affecting your blood vessels and overall cardiovascular health.

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  • Robotic-Assisted tPA Injection for Subretinal Hemorrhage Treatment

    The RoTIS study is an innovative research project aimed at improving the treatment for patients suffering from subretinal hemorrhage, a condition often associated with age-related macular degeneration. This condition can lead to a significant decrease in vision due to bleeding underneath the retina. Traditionally, treatments have involved manually injecting medication into the affected area to help clear the hemorrhage. However, this study introduces a cutting-edge approach by utilizing a robotic stabilizer to assist in the precise and stable injection of a medication called tPA directly into the subretinal space.

    During the surgery, which is part of your standard care, the surgeon will use a very thin needle, guided by a robot, to inject the tPA. This method aims to form a small bubble (bleb) in the subretinal space, helping to manage the hemorrhage more effectively. The goal is to ensure that the needle is placed accurately and remains stable for up to three minutes to allow for optimal treatment delivery.

    What makes this study particularly unique is the use of a robotic stabilizer. This tool is designed to reduce any tremors from the surgeon’s hand, ensuring the needle is precisely positioned and remains still during the injection. This level of precision is crucial, especially when dealing with delicate structures in the eye.

    Throughout the procedure, the surgical area will be closely monitored using a special type of imaging technology (iOCT) integrated into the surgical microscope. This allows the surgeon and the research team to observe the formation of the bleb in real-time, ensuring the treatment is delivered as intended.

    The RoTIS study represents a significant advancement in the treatment of subretinal hemorrhage, potentially offering patients a more effective and less invasive option. By participating in this study, you will be at the forefront of medical innovation, contributing to the development of new treatments that could benefit many people in the future.

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  • Testing a new drug for advanced prostate cancer

    This trial compares a new drug called AZD5305 with a placebo in men who have a specific kind of prostate cancer that has not responded to usual treatment methods. It’s a large trial, with around 1800 participants, and the main aim is to see whether the new treatment can help slow down the disease for longer than current treatments. Participants will be assigned to two different groups, and they will not know whether they’re receiving the real drug or the placebo. Their health will be monitored closely, with regular scans to check the progress of the cancer. The trial will also look at any side effects of the treatment and how it affects the patients’ ability to do their daily activities.

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  • Research to enhance cancer treatments for kids and teens

    This clinical trial, known as CAMPFIRE, encompasses several studies testing new drugs for children and young adults with cancer. It includes various drug combinations such as Ramucirumab, Cyclophosphamide, Vinorelbine, Gemcitabine, Docetaxel, Abemaciclib, Irinotecan, and Temozolomide. These trials aim to evaluate the safety and effectiveness of these drugs in treating different cancer types. The study is interventional, with an estimated enrollment of 105 participants, randomized in parallel assignment. The primary purpose is treatment-focused.

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  • Continued Parsaclisib treatment for B-cell cancer patients

    This is a phase II clinical trial focused on providing continuation of treatment with a drug called parsaclisib to people diagnosed with B-cell malignancies. The main goal of this study is to expand the treatment regimen established in the previous study. Study participants will receive parsaclisib as a stand-alone therapy (monotherapy) or in combination with other therapeutic agents, which may include itacitinib, ruxolitinib or ibrutinib. The study aims to facilitate participants’ ongoing care and contribute to the broader field of medical research by collecting data on the effectiveness and safety of prolonged use of parsaclisib.

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  • Testing the effectiveness and safety of povorcitinib in Asthma control

    This study involves an investigation into a medication known as povorcitinib, aimed at assessing its potential benefits for individuals with moderate to severe asthma whose current management is inadequate. The study adopts a ‘double-blind’ approach, ensuring that neither the participant nor the doctor is aware of whether the individual is receiving the actual drug or a placebo – a treatment resembling the drug but lacking any active substance. The focus lies in observing the impact of povorcitinib on lung function over a period of up to 24 weeks, with particular attention to the potential exacerbation of asthma symptoms.

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