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Clinical Trials in Italy / NCT07015190
Recruiting Phase 3

Neoadjuvant Darovasertib in Primary Uveal Melanoma

NCT07015190 · tracked via the Priya Life Science Italy tracker
Sponsor
IDEAYA Biosciences
Phase
Phase 3
Started
2026-01-25
Last updated
2026-05-06

Condition(s) studied

Uveal Melanoma

Investigational drug(s) / intervention(s)

Darovasertib →Primary Local Therapy

Darovasertib: Dosed orally, twice daily (28-day/ cycle

Primary Local Therapy: Plaque Brachytherapy or Enucleation

Study summary

This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm — Approximately 3 years
    Loss of Best Corrected Visual Acuity (BCVA) of ≥ 15 letters using Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA
  • Cohort 2: To demonstrate the ability to salvage the eye and prevent enucleation in the Treatment Arm — Approximately 2 years
    Eye preservation rate

Trial sites (94)

FacilityCityRegionStatus
Mayo Clinic Scottsdale - PPDS Scottsdale Arizona Recruiting
UCSD Moores Cancer Center La Jolla California Not Yet Recruiting
Jules Stein Eye Institute Los Angeles California Not Yet Recruiting
USC Norris Comprehensive Cancer Center Los Angeles California Not Yet Recruiting
University of California Irvine Medical Center Orange California Not Yet Recruiting
Stanford Comprehensive Cancer Center Palo Alto California Recruiting
Kaiser Permanente-Riverside Medical Center Riverside California Recruiting
UCSF Wayne and Gladys Valley Center for Vision San Francisco California Not Yet Recruiting
University of Colorado Hospital Aurora Colorado Recruiting
The Melanoma and Skin Cancer Institute Englewood Colorado Not Yet Recruiting
Mayo Clinic Jacksonville Jacksonville Florida Recruiting
USF Health Eye Institute Tampa Florida Not Yet Recruiting
Moffit Cancer Center Tampa Florida Not Yet Recruiting
Wilmer Eye Institute Baltimore Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Not Yet Recruiting
W Kellogg Eye Center Ann Arbor Michigan Not Yet Recruiting
The Cancer and Hematology Centers of West Michigan (CHCWM) Grand Rapids Michigan Recruiting
Mayo Clinic - PPDS Rochester Minnesota Recruiting
TIERING Percentiles Omaha Nebraska Not Yet Recruiting
Herbert Irving Comprehensive Cancer Center New York New York Recruiting
Memorial Sloan Kettering Cancer Center - 1275 York Ave New York New York Not Yet Recruiting
Northwell Health Cancer Institute New York New York Not Yet Recruiting
Cole Eye Institute-9500 Euclid Ave Cleveland Ohio Not Yet Recruiting
Ohio State Eye and Ear Institute Columbus Ohio Not Yet Recruiting
Retina Consultants of Oklahoma Oklahoma City Oklahoma Not Yet Recruiting
Jefferson Health Honickman Center Philadelphia Pennsylvania Not Yet Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Not Yet Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
Vanderbilt Eye Institute Nashville Tennessee Not Yet Recruiting
Austin Retina Associates - Central Austin Texas Recruiting
Texas Retina Associates - Dallas Dallas Texas Recruiting
University of Texas Southwestern Medical Center-5323 Harry Hines Blvd Dallas Texas Recruiting
Retina Consultants of Texas - (Houston) Houston Texas Not Yet Recruiting
Augusta Health, Center for Cancer and Blood Disorders Fishersville Virginia Not Yet Recruiting
University of Wisconsin Health Madison Wisconsin Not Yet Recruiting
Gallipoli Medical Research Foundation Greenslopes Queensland Not Yet Recruiting
The Queen Elizabeth Hospital Woodville South South Australia Not Yet Recruiting
The Alfred Hospital Melbourne Victoria Not Yet Recruiting
The Crown Princess Mary Cancer Centre (Westmead Hospital), NSW 214 Westmead Australia Not Yet Recruiting
LKH-Universitätsklinikum Graz Graz Austria Not Yet Recruiting

+ 54 more sites — see the full list on the official registry below.

More IDEAYA Biosciences trials in Italy

(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma Active, not recruiting
IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma Active, not recruiting

Other trials for the same condition

A Randomised Phase II Study of Roginolisib in Patients With Advanced/Metastatic Uveal Melanoma Active, not recruiting
A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma Active, not recruiting
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07015190 on ClinicalTrials.gov ↗ ← All trials in Italy