Neoadjuvant Darovasertib in Primary Uveal Melanoma
This study, called OptimUM-10, is for people with early-stage uveal melanoma, a type of eye cancer that hasn't spread. We're testing a new medication called darovasertib. In some cases, patients will receive darovasertib before their standard treatment, which could be a special type of radiation (plaque brachytherapy) or surgery to remove the eye (enucleation). Other patients will have their standard treatment right away. We want to compare these approaches to see if starting with darovasertib can lead to better results. Everyone in the study will be followed for up to three years to check their vision and if the cancer comes back.
במבט חטוף
על מה המחקר הזה?
This research study is focused on a specific type of eye cancer called uveal melanoma that hasn't spread to other parts of the body. We're investigating whether a new drug, darovasertib, given before standard treatments, can make a difference for patients. Standard treatments for uveal melanoma include a special kind of radiation therapy (plaque brachytherapy) or, in some cases, surgery to remove the eye (enucleation). The study aims to see if using darovasertib first could improve how well these standard treatments work or lead to better long-term outcomes.
The study is divided into two groups, depending on the type of treatment usually recommended for a patient's uveal melanoma. In one group, we're comparing people who get darovasertib before plaque brachytherapy to those who receive plaque brachytherapy straight away. In the second group, we're comparing people who get darovasertib before their planned primary treatment (which could be plaque brachytherapy, another type of radiation called proton beam, or enucleation) to those who have enucleation straight away.
All patients will be carefully monitored for up to three years after their treatment. During this time, the research team will check their vision and look for any signs that the cancer has returned. This will help us understand the long-term effects of darovasertib and whether it could become a valuable new step in treating uveal melanoma.
נקודות עיקריות
- This study evaluates a new drug (darovasertib) for early-stage eye cancer (uveal melanoma).
- It aims to see if darovasertib before standard treatment improves outcomes.
- Patients will be randomly assigned to different treatment groups.
- The study lasts up to three years, monitoring vision and cancer recurrence.
- It's for uveal melanoma that has not spread to other body parts.
מי עשוי להיות זכאי?
To join this study, you must have a type of eye cancer called uveal melanoma that hasn't spread to other parts of your body. You also need to be 18 years old or older. It's important that you are generally well enough to take part in the study, which means your body's organs are working properly, and you are able to sign a consent form and follow all the study instructions.
You would not be able to join this study if you have already had treatment for your uveal melanoma, or if there's evidence that your cancer has spread. Also, if there are other eye conditions that would make it difficult to properly check your vision, or if you have another type of cancer, you wouldn't be able to participate. Finally, if for some reason surgery to remove the eye is definitely needed, regardless of other treatments, then this study might not be suitable.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- Do you have uveal melanoma that hasn't spread?
- האם אתה בן 18 או יותר?
- Are you generally well and able to participate in a study?
- Have you *not* had previous treatment for your uveal melanoma?
- Do you *not* have another active cancer?
מה כרוך בהשתתפות?
If you decide to take part in this study, you would first sign an informed consent form. Depending on which group you're in, you might take the study medication, darovasertib, for a period of time before your main treatment (either radiation or surgery). During this time, and after your main treatment, you'll have regular hospital visits. These visits will involve various tests and check-ups to monitor your health, how the medication is working, and progress of your eye condition. We'll be checking things like your vision and looking for any changes in the cancer. You will be followed up for a total of three years to assess long-term outcomes. The study team will explain the full schedule of visits and assessments in detail if you are considering joining.
סיכונים ותועלות פוטנציאליים
Locations (94)
- Mayo Clinic Scottsdale - PPDSמיקוד מאומתסקוטסדייל, ארצות הברית· גיוס
- UCSD Moores Cancer Centerמיקוד מאומתלה הויה, ארצות הברית· עדיין לא מגייסים
- Jules Stein Eye Instituteמיקוד מאומתלוס אנג'לס, ארצות הברית· עדיין לא מגייסים
- מרכז הסרטן המקיף USC נוריסמיקוד מאומתלוס אנג'לס, ארצות הברית· עדיין לא מגייסים
- University of California Irvine Medical Centerמיקוד מאומתאורנג', ארצות הברית· עדיין לא מגייסים
- Stanford Comprehensive Cancer Centerמיקוד מאומתפאלו אלטו, ארצות הברית· גיוס
- Kaiser Permanente-Riverside Medical Centerמיקוד מאומתRiverside, United States· גיוס
- UCSF Wayne and Gladys Valley Center for Visionמיקוד מאומתסן פרנסיסקו, ארצות הברית· עדיין לא מגייסים
- University of Colorado Hospitalמיקוד מאומתאורורה, ארצות הברית· גיוס
- The Melanoma and Skin Cancer Instituteמיקוד מאומתEnglewood, United States· עדיין לא מגייסים
- מאיו קליניק ג'קסונווילמיקוד מאומתג'קסונוויל, ארצות הברית· גיוס
- USF Health Eye Instituteמיקוד מאומתטמפה, ארצות הברית· עדיין לא מגייסים
שאלות נפוצות
What is uveal melanoma?
Uveal melanoma is a rare type of cancer that develops in the eye. This study is specifically for cases that have not spread to other parts of the body.
What is darovasertib?
Darovasertib is a new medication being tested to see if it can help treat uveal melanoma by affecting how the cancer cells grow.
What does 'neoadjuvant' mean?
'Neoadjuvant' means that the treatment (in this case, darovasertib) is given before the main, more definitive treatment like surgery or radiation.
האם אני בהחלט אקבל את התרופה החדשה?
Not necessarily. This is a randomised study, meaning some participants will receive darovasertib before their standard treatment, while others will have their standard treatment straight away. Your doctor will explain which group you might be in.
כמה זמן אהיה מעורב במחקר?
If you join the study, you will be followed for up to three years to monitor your health and the long-term effects of the treatments.
כיצד לגלות עוד
IDEAYA Clinical Trials
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