Neoadjuvant Darovasertib in Primary Uveal Melanoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor: IDEAYA Biosciences
Study ID: NCT07015190
Phase: PHASE3
Status: Recruiting

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Conditions

Uveal Melanoma

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Darovasertib — DRUG
Dosed orally, twice daily (28-day/ cycle
Primary Local Therapy — PROCEDURE
Plaque Brachytherapy or Enucleation

Study Details

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

Key Dates

Start date: Jan 25, 2026
Status verified: Sep 2025
Primary completion: Oct 31, 2030
Completion: Mar 31, 2031

Study Design

Enrollment: 520 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Treatment Arm
Darovasetib followed by definitive primary local therapy (i.e., PB, proton beam radiation, or enucleation)
Active Comparator: Control Arm
Immediate Primary Local therapy

Primary Outcome Measure

Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm [ Time Frame: Approximately 3 years ]

Central Contacts

IDEAYA Clinical Trials
+1-855-433-2246
[email protected]
Mwe Mwe Chao, MD
[email protected]

Locations (35)

Facility	City	State	ZIP	Site coordinators
Mayo Clinic Scottsdale - PPDS	Scottsdale	Arizona	85259	Odette Houghton, MD Principal Investigator
UCSD Moores Cancer Center	La Jolla	California	92093	Gregory Daniels, MD Principal Investigator
Jules Stein Eye Institute	Los Angeles	California	90024	Tara McCannel, MD Principal Investigator
USC Norris Comprehensive Cancer Center	Los Angeles	California	90033	Gino In, MD, Principal Investigator
University of California Irvine Medical Center	Orange	California	92868	Poorva Vaidya, MD Principal Investigator
Stanford Comprehensive Cancer Center	Palo Alto	California	94304	Pauline Funchain, MD Principal Investigator
Kaiser Permanente-Riverside Medical Center	Riverside	California	92505-3043	Helen Moon, MD Principal Investigator
UCSF Wayne and Gladys Valley Center for Vision	San Francisco	California	94143	Armin Afshar, MD, Principal Investigator
University of Colorado Hospital	Aurora	Colorado	80045	Sapna Patel, MD Principal Investigator
The Melanoma and Skin Cancer Institute	Englewood	Colorado	80113-2791	Ryan Weight, MD Principal Investigator
Mayo Clinic Jacksonville	Jacksonville	Florida	32224	Bently Doonan, MD Principal Investigator
Moffit Cancer Center	Tampa	Florida	33612	Nikhil Khushalani, MD, Principal Investigator
USF Health Eye Institute	Tampa	Florida	33612-6601	Jorge Agi, MD Principal Investigator
Wilmer Eye Institute	Baltimore	Maryland	21287-0005	James Handa, MD Principal Investigator
Massachusetts General Hospital	Boston	Massachusetts	02114	Kamaneh Montazeri, MD Principal Investigator
W Kellogg Eye Center	Ann Arbor	Michigan	48105	Hakan Demirci, MD Principal Investigator
The Cancer and Hematology Centers of West Michigan (CHCWM)	Grand Rapids	Michigan	49503	Sreenivasa Chandana, MD Principal Investigator
Mayo Clinic - PPDS	Rochester	Minnesota	55905	Lauren Dalvin, MD Principal Investigator
TIERING Percentiles	Omaha	Nebraska	68105	Pukhraj Rishi, MD Principal Investigator
Herbert Irving Comprehensive Cancer Center	New York	New York	10032	Benjamin Izar, MD Principal Investigator
Memorial Sloan Kettering Cancer Center - 1275 York Ave	New York	New York	10065-6635	Jasmine Francis, MD Principal Investigator
Northwell Health Cancer Institute	New York	New York	11042	Shaheer Khan, MD Principal Investigator
Cole Eye Institute-9500 Euclid Ave	Cleveland	Ohio	44195	Lucy Kennedy, MD Principal Investigator
Ohio State Eye and Ear Institute	Columbus	Ohio	43212	Colleen Cebulla, MD Principal Investigator
Retina Consultants of Oklahoma	Oklahoma City	Oklahoma	73112	Brian Firestone, MD, Principal Investigator
Jefferson Health Honickman Center	Philadelphia	Pennsylvania	19107	Marlana Orloff, MD Principal Investigator
UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania	15232	Yana Najjar, MD Principal Investigator
SCRI Oncology Partners	Nashville	Tennessee	37203	Meredith McKean, MD Principal Investigator
Vanderbilt Eye Institute	Nashville	Tennessee	37232	Paul Sternberg, MD, Principal Investigator
Austin Retina Associates - Central	Austin	Texas	78705	Shelley Ghafoori, MD Principal Investigator
Texas Retina Associates - Dallas	Dallas	Texas	75231	Timothy Fuller, MD Principal Investigator
University of Texas Southwestern Medical Center-5323 Harry Hines Blvd	Dallas	Texas	75390-9057	Sanjay Chandrasekaran, MD Principal Investigator
Retina Consultants of Texas - (Houston)	Houston	Texas	77030-2727	Amy Schefler, MD Principal Investigator
Augusta Health, Center for Cancer and Blood Disorders	Fishersville	Virginia	22939	Kelvin Rayborn, MD Principal Investigator
University of Wisconsin Health	Madison	Wisconsin	53705-3644	Michael Altaweel, MD Principal Investigator

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By research site

Mayo Clinic Scottsdale - PPDS· Scottsdale, AZ UCSD Moores Cancer Center· La Jolla, CA Jules Stein Eye Institute· Los Angeles, CA USC Norris Comprehensive Cancer Center· Los Angeles, CA University of California Irvine Medical Center· Orange, CA Stanford Comprehensive Cancer Center· Palo Alto, CA

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