Recruiting
Phase 3

Darovasertib

Sponsor:

IDEAYA Biosciences

Code:

NCT07015190

Conditions

Uveal Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Darovasertib

Primary Local Therapy

Study Details

Brief 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)

Conditions

Uveal Melanoma

Study ID

NCT07015190

Start date

Jan 25, 2026

Status verified date

Sep, 2025

Completion date

Mar, 2031

Anticipated

Primary completion date

Oct, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

520 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Darovasertib

Dosed orally, twice daily (28-day/ cycle

Primary Local Therapy

Plaque Brachytherapy or Enucleation

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 ]
  • Cohort 2: To demonstrate the ability to salvage the eye and prevent enucleation in the Treatment Arm [ Time Frame: Approximately 2 years ]

Central Contacts and Locations

Central contacts

IDEAYA Clinical Trials

+1-855-433-2246IDEAYAClinicalTrials@ideayabio.com

Mwe Mwe Chao, MD

mchao@ideayabio.com

Locations

Mayo Clinic Scottsdale - PPDS

Recruiting

Scottsdale, Arizona, United States, 85259

Stanford Comprehensive Cancer Center

Recruiting

Palo Alto, California, United States, 94304

Kaiser Permanente-Riverside Medical Center

Recruiting

Riverside, California, United States, 92505-3043

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Wilmer Eye Institute

Recruiting

Baltimore, Maryland, United States, 21287-0005

The Cancer and Hematology Centers of West Michigan (CHCWM)

Recruiting

Grand Rapids, Michigan, United States, 49503

Mayo Clinic - PPDS

Recruiting

Rochester, Minnesota, United States, 55905

Herbert Irving Comprehensive Cancer Center

Recruiting

New York, New York, United States, 10032

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Austin Retina Associates - Central

Recruiting

Austin, Texas, United States, 78705

Texas Retina Associates - Dallas

Recruiting

Dallas, Texas, United States, 75231

University of Texas Southwestern Medical Center-5323 Harry Hines Blvd

Recruiting

Dallas, Texas, United States, 75390-9057

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

More Information

Sponsor

IDEAYA Biosciences

Last update posted

May 6, 2026

Last verified

Sep, 2025

Keywords

  • Uveal Melanoma
  • Plaque Brachytherapy
  • Enucleation
  • Neoadjuvant
  • Darovasertib
  • IDE 196
  • Ocular Melanoma
  • Choroidal Melanoma
  • Ophthalmology
  • Ocular Oncology
  • Melanoma
  • Protein Kinase C
  • GNAQ
  • GNA11

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by IDEAYA Biosciences on 2026-05-06.