Country: Italy

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  • CT-EU-00117573

    Study of Combination Therapy for Melanoma After Anti-PD-1 Treatment

    This clinical trial is comparing two different treatment approaches for advanced melanoma, which is a type of skin cancer that has spread to other parts of the body. If you have a specific gene mutation called BRAF and have previously received treatment with certain immunotherapy drugs like nivolumab or pembrolizumab, you may be eligible for this study.

    One treatment approach involves receiving three study medicines: pembrolizumab given through an IV every 3 weeks, along with encorafenib and binimetinib taken by mouth daily at home. The other approach involves receiving two study medicines: ipilimumab and nivolumab given through an IV every 3 weeks for the first 4 doses, followed by nivolumab alone every 4 weeks. Both treatment approaches will be given for around 2 years, but there is no time limit for the encorafenib and binimetinib treatment.

    The study team will closely monitor your condition during regular visits to the clinic to see how you are responding to the treatment. The main goal is to determine which treatment approach is more effective in shrinking or eliminating the melanoma tumors. Around 150 participants will be enrolled in this study and randomly assigned to one of the two treatment groups.

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  • Pembrolizumab and electrochemotherapy performed using a cliniporator in the treatment of malignant melanoma

    This study is looking at the use of pembrolizumab (Keytruda) in combination with a treatment called electrochemotherapy (ECT) in people with malignant melanoma. The main goal is to see if combining these two treatments is safe and can improve the effectiveness of the therapy in shrinking tumors, both those on the surface of the skin and those found in the body.

    Electrochemotherapy involves using electrical pulses along with a drug called Bleomycin to kill cancer cells. This is thought to help the immune system better recognize and attack cancer. Pembrolizumab is an immunotherapy drug that inhibits the cells of the immune system that fight cancer. Scientists believe that by combining these two approaches, a better anti-tumor response can be achieved compared to using pembrolizumab alone.

    Italy
  • 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.

    FranceGermanyItalyNetherlandsUnited Kingdom
  • Study on Secukinumab for Rotator Cuff Tendinopathy

    This here clinical trial is aimin’ to see if a new medicine called secukinumab can help folks with moderate to severe rotator cuff tendinopathy, which is a painful condition affectin’ the shoulder. The study will compare secukinumab to a placebo, which is like a fake medicine with no active ingredients.

    Now, if you join this trial, you’ll be given either secukinumab or the placebo by injection under the skin every week for the first month, and then once a month after that for another couple of months. The doctors will be keepin’ a close eye on your shoulder symptoms like pain, weakness, stiffness, and any mechanical issues you might be havin’.

    The main thing they’ll be lookin’ at is how much your physical shoulder symptoms improve after 16 weeks of treatment with secukinumab compared to the placebo. They’ll be usin’ a special questionnaire called the Western Ontario Rotator Cuff Index to measure them symptoms.

    Now, durin’ the trial, you’ll need to keep takin’ any anti-inflammatory medicines you’re already on, and keep up with your physical therapy exercises too. But you won’t be allowed to get no steroid injections or increase your medicine doses without the doctors’ say-so.

    After the 16 weeks of treatment, there’ll be another 8 weeks where the doctors will check if the effects of the medicine are lastin’. So in total, you’d be in the study for around 6 months if you join up.

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  • Clinical Trial for Finding the Best Dose of Clodronate for Painful Knee Osteoarthritis

    Howdy there, folks! This here clinical trial is aimin’ to find the best dose of a medicine called clodronate for treatin’ painful knee arthritis. It’s gonna be split into two parts.

    In the first part, they’ll have four groups of folks with knee arthritis. Three of them groups will get different doses of clodronate injected right into their knee once a week for four weeks. The fourth group will get a placebo, which is like a fake medicine. They’ll be keepin’ an eye on how safe and tolerable them different doses are.

    Once they figure out which dose works best without too many side effects, they’ll move on to the second part. In that part, they’ll have two groups – one gettin’ the best dose of clodronate from the first part, and the other gettin’ a placebo again. They’ll be checkin’ to see how effective and safe that best dose really is for helpin’ with knee arthritis pain.

    The main thing they’re lookin’ for is if the clodronate can reduce knee pain by at least 10 millimeters on a special pain scale called the Visual Analogue Scale, compared to the placebo group. They’ll be measurin’ that around 7 weeks into the study.

    So in a nutshell, they’re tryin’ to find the best and safest dose of clodronate for helpin’ folks with painful knee arthritis. It’s a two-part study, and they’ll be keepin’ a close eye on how well it works and how well it’s tolerated.

    Italy
  • 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.

    FranceGermanyItalyNetherlandsRomaniaSpain
  • 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.

    AustriaBelgiumFranceGermanyItalyPolandSpainUnited Kingdom
  • 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.

    BelgiumCzechiaFranceGermanyGreeceItalyPolandRomaniaSpainUnited Kingdom
  • 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.

    AustriaBelgiumCzechiaFranceGermanyItalySpainUnited Kingdom
  • NCT04305054

    This here clinical trial, called KEYMAKER-U02 Substudy 02B, is aimin’ to test some new experimental treatments for melanoma, which is a type of skin cancer. The main goal is to see if these new treatments are safe an’ effective when used alone or combined with the drug pembrolizumab.

    Now, the trial has several different “arms” or treatment groups. Some groups are gettin’ pembrolizumab combined with other investigational drugs like vibostolimab, quavonlimab, lenvatinib, favezelimab, or ATRA. Other groups are just gettin’ pembrolizumab by itself.

    The researchers will be keepin’ a close eye on things like dose-limiting toxicities an’ adverse events to make sure the treatments are safe. They’ll also be lookin’ at how well the treatments work by measurin’ things like the objective response rate, which shows if the tumors are shrinkin’ or disappearin’.

    If you’re interested in joinin’ this trial, you’ll wanna ask your doctor about the potential risks an’ benefits, an’ whether you might be a good fit for one of them treatment arms. Just remember, this here is an experimental study, so the treatments ain’t approved yet for regular use.

    FranceGreeceHungaryItalyPolandSpain
  • 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
  • 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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