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New treatment option for Uveal Melanoma
Official title Neoadjuvant Darovasertib in Primary Uveal Melanoma
ClinicalTrials.gov ID: NCT07015190
What this study is testing
What is Darovasertib?
Darovasertib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for uveal melanoma.
Also referred to as IDE 196.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
- Phase 3: a large, late-stage study
- Time commitment: about 3 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Primary non-metastatic uveal melanoma
- Able and willing to provide written, informed consent before initiation of any study-related procedures, and in the opinion of the Investigator, to...
- ECOG 0 or 1
- Adequate organ function
You likely can't join if
- Previous treatment for UM
- Evidence of metastatic UM
- Attributes that necessitate enucleation regardless of response to therapy
- Evidence of progressive secondary underlying ocular disease that would confound longitudinal VA assessments
- Presence of a malignant disease other than the one being treated in this study
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Riverside, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Englewood, Colorado, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Grand Rapids, Michigan, United States
- Rochester, Minnesota, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
+ 68 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States; Orange, California, United States; Palo Alto, California, United States; Riverside, California, United States and 82 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.