Darovasertib before local treatment for primary uveal melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized, multicenter, open-label trial enrolls patients with primary non-metastatic uveal melanoma and assigns them to receive neoadjuvant darovasertib or immediate local therapy. The study is split into two cohorts: one compares darovasertib followed by plaque brachytherapy versus immediate plaque brachytherapy, and the other compares darovasertib followed by definitive local therapy versus immediate enucleation. After neoadjuvant therapy participants receive planned local treatment and are followed for up to three years to track vision, tumor control, and recurrence. Key outcomes include eye preservation rates, visual acuity changes, and longer-term tumor recurrence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 comply with all study requirements
* ECOG 0 or 1
* Adequate organ function

Exclusion Criteria:

* 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

Where it's running

• Mayo Clinic Scottsdale - PPDS
  Scottsdale, Arizona, United States Recruiting
• Stanford Comprehensive Cancer Center
  Palo Alto, California, United States Recruiting
• Kaiser Permanente-Riverside Medical Center
  Riverside, California, United States Recruiting
• University of Colorado Hospital
  Aurora, Colorado, United States Recruiting
• Mayo Clinic Jacksonville
  Jacksonville, Florida, United States Recruiting
• Wilmer Eye Institute
  Baltimore, Maryland, United States Recruiting

+44 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: IDEAYA Clinical Trials
• Email: IDEAYAClinicalTrials@ideayabio.com
• Phone: +1-855-433-2246

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.