Neoadjuvant Darovasertib in Primary Uveal Melanoma

RecruitingPhase 3

A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

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

About the study

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

What is being tested

Darovasertib (drug)
Primary Local Therapy (procedure)

Sponsor: IDEAYA Biosciences · Participants: 520 · Started: Jan 25, 2026

Contact the study team

IDEAYA Clinical Trials · Phone: +1-855-433-2246

Official record on ClinicalTrials.gov — NCT07015190

Locations in the U.S.

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

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.