Country: Netherlands

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.

  • A study comparing the combination of lifileucel plus pembrolizumab with pembrolizumab alone in the treatment of unresectable, advanced melanoma

    The aim of this study is to test a new treatment for people with advanced melanoma, a serious form of skin cancer that has spread to other parts of the body. The new treatment combines two different therapies: lifileucel, made from the patient’s own immune cells called tumor-infiltrating lymphocytes, and pembrolizumab, a type of immunotherapy drug that helps the body’s immune system fight cancer.

    The study will compare the effectiveness and safety of this combination treatment with pembrolizumab alone. Patients who initially received only pembrolizumab and whose cancer worsened will have the option to switch treatment and receive lifileucel monotherapy.

    The main goals of the study are to see whether the combination treatment can improve the objective response rate, which measures how many patients have had their tumors shrink, and progression-free survival, which is how long patients live without their cancer getting worse. To evaluate the results of the study, patients will be followed for up to 5 years.

    To be eligible for this trial, patients must have advanced melanoma that cannot be surgically removed or has spread to other organs. Additionally, patients cannot be previously treated for metastatic disease, although some prior therapies for earlier stages of melanoma are permitted.

  • Study of darovasertib in patients with uveal melanoma

    This is a study of a new drug called darovasertib (also known as IDE196 or LXS196) in patients with primary choroidal melanoma. Darovasertib is an oral, potent and selective protein kinase C inhibitor that will be used to treat uveal melanoma.

    The aim of this study is to see if darovasertib can help reduce the size of the tumor before local treatment, such as removal of the eyeball or radiation. Patients will receive darovasertib for a maximum of 6 months before local treatment, and then for a further 6 months after local treatment. Doctors will watch to see if the drug helps avoid having to remove the eyeball or reduce the dose of radiation needed to treat the tumor.

    It is important to monitor for any side effects and changes in laboratory tests while taking darovasertib. Doctors will closely monitor the patient’s health throughout the study, which may last up to 3 years.

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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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  • A Study Comparing ABP 206 and Nivolumab for Resected Melanoma

    This here clinical trial is aimin’ to see if a new drug called ABP 206 works just as good as the approved cancer drug OPDIVO® (nivolumab) for folks with advanced melanoma skin cancer that’s been removed by surgery. The study is splittin’ folks into 3 groups, with one group gettin’ ABP 206, another gettin’ the real OPDIVO® approved in the U.S., and the third gettin’ the version of OPDIVO® approved in Europe. All these drugs will be given through an IV drip every 4 weeks for up to 1 year, or until the cancer comes back or gets too bad.

    The main goal is to check if ABP 206 gets absorbed and stays in the body the same way as OPDIVO®. They’ll also be keepin’ a close eye on how well it works, any side effects, and if the body makes antibodies against it. The whole study will last around 13 months for each person joinin’. It’s a double-blind study, meanin’ neither the folks gettin’ the drugs nor the doctors givin’ ’em will know which one they’re gettin’ until the end.

  • Study of a new drug – DYP688 for patients with uveal melanoma and other melanomas with the GNAQ/11 mutation

    This study is testing a new drug called DYP688 for people with metastatic uveal melanoma. It is a type of eye cancer that has spread to other parts of the body. Other types of cutaneous melanoma that have certain gene mutations called GNAQ/11 are also being studied.

    The process consists of two main parts. The first part, called the dose escalation phase, aims to find the highest safe dose of DYP688 that can be given without too many side effects. This section includes patients with metastatic uveal melanoma and other melanomas with a GNAQ/11 mutation.

    Once the right dose is determined in the second part, called Phase II, DYP688 will be tested in three groups of patients: people with metastatic uveal melanoma who have previously received another medicine called tebentafusp, people with metastatic uveal melanoma who has not received tebentafusp before, and the third group with melanomas with the GNAQ/11 mutation.

    The main goal is to see how well DYP688 works at reducing or stopping the development of these cancers and to see if there are any serious side effects.

  • 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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  • NCT05767879

    Howdy there, partner! This here’s a Phase 2 study aimin’ to test out a new combination of drugs called encorafenib and binimetinib for folks with in-transit melanoma – that’s a type of skin cancer that’s spread to nearby areas but not yet to the lymph nodes or other parts of the body.

    The study’s got two main parts. First, you’ll take these drugs for 8 weeks before surgery to see how well they work at shrinkin’ or even gettin’ rid of the cancer. The doc’ll take a biopsy at the start and end to check how much the tumor’s changed. Then, after your surgery, you’ll keep takin’ the same drugs for another 44 weeks to try and prevent the cancer from comin’ back.

    The main goal is to see how many folks get a partial response, where at least half the tumor cells are gone, or a complete response, where there’s no livin’ cancer cells left at all. The study’ll also keep an eye on whether the drugs help stop the cancer from spreadin’ or comin’ back after surgery, and how well folks tolerate any side effects.

    So in a nutshell, it’s a chance to try out these new targeted therapies before and after surgery for a certain type of melanoma. The docs are hopin’ this one-two punch can pack a mighty wallop against the cancer. Whaddya say, pardner? Interested in joinin’ the fight?

  • 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.

    AustriaBelgiumCzechiaFranceGermanyHungaryItalyNetherlandsPolandRomaniaSpainUnited Kingdom
  • Adalimumab-800CW distribution study and its fluorescence imaging in inflammatory bowel diseases and rheumatoid arthritis

    This clinical trial used a special fluorescent version of the drug adalimumab to precisely examine its distribution in inflamed areas in people with inflammatory bowel disease (IBD) and rheumatoid arthritis (RA). These autoimmune diseases provoke the body’s immune system to attack the intestines or joints, leading to significant inflammation and discomfort.

    Typically, adalimumab works by inhibiting a protein called tumor necrosis factor alpha (TNFa), a major trigger of inflammation. However, the effectiveness of this medicine may vary and the reasons for this are not always clear. Therefore, in this study, adalimumab was combined with a special luminous dye, called adalimumab-800CW, that allows the drug to be precisely tracked in inflamed areas using advanced imaging techniques.

    The primary goal is to determine whether the glowing adalimumab reaches targeted inflamed areas in the gut or joints and to assess whether the level of accumulation correlates with therapeutic efficacy in each participant. The insights gained are intended to increase the ability to predict treatment response and adjust dosing for individual patients before initiating therapy.

    Participants in this study will be given a low dose of glowing adalimumab a few days before undergoing specialized imaging tests or endoscopy to monitor the drug’s location in the body. The safety and well-being of participants will be closely monitored throughout the study.

  • TolDCB29 dendritic cell therapy in the treatment of rheumatoid arthritis

    This study aims to evaluate a new treatment for people suffering from rheumatoid arthritis. The treatment involves taking parts of a person’s own immune cells, called dendritic cells, and filling them with a special protein called B29 peptide. This produces TolDCB29, which is then injected back into the body near the lymph nodes in the groin area.

    The main goal of this study is to determine whether TolDCB29 treatment is safe for patients with rheumatoid arthritis. Scientists also want to see if it can help train the immune system to stop attacking the body’s own body, which causes joint inflammation and damage in rheumatoid arthritis.

    The patient will receive two injections of TolDCB29 approximately four weeks apart. Study doctors will start by giving a low dose to a small group, then increase the dose to the next group until they find the highest safe dose. Patients will be closely monitored for any side effects or worsening of symptoms of rheumatoid arthritis.

    This study only includes adults over 18 years of age with rheumatoid arthritis that has been well controlled with current medications for at least 12 weeks. During the study, patients can continue to take their existing arthritis medications, except Janus kinase inhibitors.

  • Study of asciminib dosing and safety in pediatric patients with Chronic Myeloid Leukemia

    This study is designed to determine the appropriate dosing and assess the safety of the drug asciminib for children and teenagers who have a specific type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML-CP). These patients have previously been treated with at least one other medication known as a tyrosine kinase inhibitor (TKI). The study involves giving different doses of asciminib to see how well the drug works and how safe it is in young patients. The study will enroll participants into two age groups and will follow them over a five-year period to observe the effects of the treatment.

  • Study Comparing Asciminib and Nilotinib for Newly Diagnosed Chronic Myeloid Leukemia

    This study examines the effects and tolerance of two drugs, asciminib and nilotinib, for treating a specific type of leukemia called Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in its chronic phase. The participants are adults who have been newly diagnosed and have not received previous treatment for this condition. They will be randomly assigned to receive either asciminib or nilotinib. The study aims to see which drug is better tolerated and how effective they are. Throughout the study, participants will be monitored for any side effects and the progress of their treatment until they either experience significant side effects, the disease progresses, or they decide to stop the treatment. Follow-up checks will also be conducted after the treatment ends.

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  • To evaluate the efficacy and safety of burfiralimab in combination with standard treatment for rheumatoid arthritis

    The study is investigating a new treatment option for people with moderate to severe rheumatoid arthritis (RA). This study focuses on assessing the effectiveness and safety of a drug called burfiralimab, administered as intravenous infusions. The drug is being tested alongside standard treatments for RA, known as disease-modifying antirheumatic drugs, to see if it can provide better relief from RA symptoms.

    This is a multicenter, randomized, double-blind, placebo-controlled study. This means that participants will be randomly assigned to receive the drug burfiralimab or a placebo, and neither participants nor researchers will know who is receiving which treatment. This helps ensure the results are impartial.

    Study participants will receive biweekly intravenous infusions of burfiralimab or placebo for a total of 10 weeks. The main goal is to see whether people receiving burfiralimab experience significant improvement in RA symptoms compared to those receiving placebo. Improvement is measured by ACR 20 criteria, which include a reduction in joint swelling and tenderness.

    The study is open to people aged 18 to 80 who have moderate to severe RA and have not responded well to standard therapy. The safety and effects of treatment will be closely monitored throughout the study period, with particular emphasis on improving disease activity and quality of life for up to 18 weeks after treatment initiation.

  • Study of the effects of filgotinib on B cells in patients with rheumatoid arthritis

    This clinical trial focuses on the treatment of Rheumatoid Arthritis (RA), specifically in patients who have not fully responded to standard treatments like methotrexate. The study is exploring the effectiveness of a medication called Filgotinib, which works by targeting and inhibiting certain enzymes in the body known as Janus kinases. These enzymes are involved in the inflammation and immune response that contribute to RA. By inhibiting these enzymes, Filgotinib may help reduce the activity of harmful B cells that produce anti-citrullinated protein antibodies (ACPA), which are believed to play a key role in driving the disease.

    The trial will compare the effects of Filgotinib to another medication called Adalimumab, which works by targeting a different part of the immune response. The main goal is to see if there is a change in the frequency of ACPA-expressing B cells after 24 weeks of treatment. This could indicate whether Filgotinib is effective in altering the course of the disease by targeting these specific cells.

    Patients participating in this study have RA and are ACPA-positive, meaning their condition is associated with a specific type of antibody that is linked to more severe disease activity. The study is particularly interested in those who have not fully benefited from methotrexate, a commonly used medication for RA. By joining this trial, patients have the opportunity to receive a potentially new treatment that could offer better control of their RA symptoms and disease progression.

  • Study of the safety and effects of SOL-116 in healthy subjects and patients with rheumatoid arthritis

    This is a study of a monoclonal antibody (SOL-116) targeting BSSL (biliary salt-stimulated lipase). The study aims to investigate a new treatment option that could potentially provide relief to people suffering from rheumatoid arthritis. This is a phase I placebo-controlled trial, which means that participants will be randomly assigned to receive the study drug or a placebo. Neither participants nor the research team will know who is receiving the actual drug, ensuring the results are unbiased.

    The study is divided into three parts. In the first part, different doses of the drug will be tested on healthy volunteers to find the safest dose. In the second part, this dose will be tested in patients with rheumatoid arthritis. Finally, the third part will involve administering the drug repeatedly to healthy volunteers to understand how the body responds to it over time.

    Throughout the study, the safety, and tolerability of SOL-116 will be closely monitored by monitoring for any adverse events, changes in clinical laboratory assessments, immune responses, and changes in vital signs such as blood pressure, heart rate, and body temperature. You will also be checked for reactions at the injection site, and an electrocardiogram (ECG) will be taken to monitor your heart health.

    The study will last approximately 90 days from screening to completion, during which time it will collect valuable information on how SOL-116 is processed in the body (pharmacokinetics) and its safety and tolerability.