Study on Darovasertib Before Surgery for Primary Uveal Melanoma
Sponsor: IDEAYA Biosciences
ClinicalTrials ID:NCT07015190
This clinical trial is testing the use of the drug darovasertib before surgery in patients with primary uveal melanoma, a type of eye cancer that has not spread. The study aims to see if this approach can improve treatment outcomes.
Patient Parameters
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Program Overview
This Phase 3 study is exploring whether using the drug darovasertib before surgery can help treat primary uveal melanoma, a type of eye cancer that hasn't spread. The study involves two groups of patients: one group will receive darovasertib before surgery, while the other group will have surgery without the drug. Researchers will follow all participants for up to 3 years to monitor their vision and check if the cancer returns.
Description
The study is divided into two groups based on the type of surgery needed for primary uveal melanoma.
In the first group, patients will receive the drug darovasertib before undergoing a type of radiation therapy called plaque brachytherapy. This will be compared to patients who receive immediate plaque brachytherapy without the drug.
In the second group, patients will receive darovasertib before their main treatment, which could be plaque brachytherapy, proton beam radiation, or removal of the eye (enucleation). This will be compared to patients who have immediate eye removal without the drug.
After receiving darovasertib, all patients will undergo their main treatment. Researchers will follow up with patients for up to 3 years to see how their vision is affected and if the cancer comes back.
Eligibility Criteria
Inclusion Criteria
- Have primary uveal melanoma that has not spread.
- Be able and willing to provide written consent and follow all study requirements.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have adequate organ function as determined by medical tests.
Exclusion Criteria
- Have received previous treatment for uveal melanoma.
- Have evidence that the cancer has spread.
- Have conditions that require eye removal regardless of treatment response.
- Have other eye diseases that could affect vision assessments over time.
- Have another type of cancer besides the one being treated in this study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Scottsdale - PPDS | 85259 | Scottsdale | Arizona |
| UCSD Moores Cancer Center | 92093 | La Jolla | California |
| University of California Irvine Medical Center | 92868 | Orange | California |
| Stanford Comprehensive Cancer Center | 94304 | Palo Alto | California |
| Kaiser Permanente-Riverside Medical Center | 92505-3043 | Riverside | California |
| University of Colorado Hospital | 80045 | Aurora | Colorado |
| The Melanoma and Skin Cancer Institute | 80113-2791 | Englewood | Colorado |
| Mayo Clinic Jacksonville | 32224 | Jacksonville | Florida |
| Wilmer Eye Institute | 21287-0005 | Baltimore | Maryland |
| Massachusetts Eye and Ear Infirmary | 02114 | Boston | Massachusetts |
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