Overview Study Design Endpoints Trial Locator

A phase 2, multicenter, open-label study1

NCT05907954

Currently active but not enrolling

The trial at a glance

OptimUM-09 is designed to evaluate darovasertib in patients with primary uveal melanoma (UM) requiring either enucleation or plaque brachytherapy in the neoadjuvant setting. Patients will be treated for up to 12 months or maximum benefit followed by primary local therapy.1

Patients with primary UM requiring either enucleation (cohort 1) or plaque brachytherapy (cohort 2)1

PART 1: NEOADJUVANT1,2

Darovasertib 300 mg BID for 12 cycles. Treat to maximum benefit with assessment each cycle (28 days)

DEFINITIVE PRIMARY THERAPY1,2

Cohort 1: Surgery | Cohort 2: Radiation

PART 2: ADJUVANT1,2

Darovasertib 300 mg BID for 6 cycles; start ~4-6 weeks after surgery/radiation

Primary endpoints

All patients

  • Incidence of adverse events (AEs) and significant laboratory abnormalities1

In patients requiring enucleation

  • Number of patients converted from requiring enucleation to radiation1

In patients requiring plaque brachytherapy

  • Estimated change in modeled radiation dose. Doses to the fovea and optic disc are modeled with initial tumor size and posttreatment tumor size1

In patients with small UM tumors

  • Number of patients with clinical benefit per protocol-defined UM response criteria1
Checkmark

SELECT INCLUSION CRITERIA1

  • Age 18 years or older
  • Primary localized UM requiring either enucleation or plaque brachytherapy
  • ECOG performance status ≤1
  • No other significant underlying ocular disease

In patients with small UM tumors 

  • Clinically diagnosed uveal (not iris) melanoma <4 mm in thickness
X Mark

SELECT EXCLUSION CRITERIA1,3

  • Metastatic disease
  • Extraocular involvement
  • Life expectancy <3 months
  • Symptomatic or untreated CNS metastases
  • Previous treatment with a protein kinase C (PKC) inhibitor
  • Concurrent malignant disease
  • Active HIV infection or hepatitis B or hepatitis C
  • Malabsorption disorder
  • Unable to discontinue prohibited medication
  • Impaired cardiac function or clinically significant cardiac disease

BID, twice daily; CNS, central nervous system; ECOG, Eastern Cooperative Oncology Group.

Trial site locations

OptimUM-09 is available globally. Browse below to view participating sites.

New South Wales, Australia

St. Vincent's Health Sydney

Sydney 2010

Victoria, Australia

Alfred Health

Melbourne 3004

Ontario, Canada

Princess Margaret Cancer Centre

Toronto M5G2M9

London, England

University College London Hospital - NHS Foundation Trust

London NW1 2PG

Merseyside, England

The Clatterbridge Cancer Centre NHS Foundation Trust

Wirral CH63 4JY

Île-de-France, France

Institut Curie

Paris 75005

Berlin, Germany

Charité - Universitätsmedizin Berlin

Berlin 12203

Campania, Italy

Istituto Nazionale Tumori IRCCS - Fondazione Pascale

Naples 80131

Lazio, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome 00168

Lombardy, Italy

Fondazione IRCCS Istituto Nazionale Tumori

Milan 20133

South Holland, Netherlands

Leiden University Medical Center

Leiden 2333ZA

Arizona, United States

HonorHealth Research Institute

Scottsdale 85258

California, United States

Moores Cancer Center

La Jolla, CA 92093

California, United States

UCLA Medical Center

Los Angeles, CA 90024

California, United States

Stanford Cancer Institute

Palo Alto, CA 94305

Colorado, United States

Sarah Cannon Research Institute

Denver, CO 80218

Florida, United States

University of Miami

Miami, FL 33146

Michigan, United States

The Cancer and Hematology Centers

Grand Rapids, MI 49546

Minnesota, United States

Mayo Clinic Rochester

Rochester, MN 55905

New York, United States

Northwell

Manhasset, NY 11030

North Carolina, United States

Duke University Health System

Durham, NC 27710

Pennsylvania, United States

Thomas Jefferson University

Philadelphia, PA 19107

Tennessee, United States

Sarah Cannon Research Institute

Nashville, TN 37203

Texas, United States

University of Texas Southwestern Medical Center

Dallas, TX 75390

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Darovasertib is an investigational product and has not been approved by the U.S. Food and Drug Administration for safety or effectiveness.

References: 1. (Neo)adjuvant IDE196 (darovasertib) in patients with localized ocular melanoma. ClinicalTrials.gov identifier: NCT05907954. Updated October 22, 2025. Accessed January 14, 2026. https://www.clinicaltrials.gov/study/NCT05907954 2. Butler MO, Reichstein D, Krema H, et al. Enucleation prevention and vision preservation in primary uveal melanoma (UM): preliminary results from a phase 2 study of neoadjuvant darovasertib (OptimUM-09). Presented at: European Society for Medical Oncology; October 2025; Berlin, Germany. 3. Data on file. Ideaya Biosciences, 2025.