Neoadjuvant Darovasertib in Primary Uveal Melanoma

NCT07015190 · tracked via the Priya Life Science USA 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)

DarovasertibPrimary 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

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)

Facility	City	Region	Status
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 the USA

Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma Recruiting

(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma Active, not recruiting

A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types Recruiting

A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer Recruiting

A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors Recruiting

Other trials for the same condition

Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma Recruiting

(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma Active, not recruiting

A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Express c-Kit Recruiting

A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors 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

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 the USA