Early access
Sign in
Taking people in United StatesPhase 3

Tests darovasertib before surgery or radiation for uveal melanoma

Tests darovasertib given before primary local therapy in adults with uveal melanoma.

Key facts

Who runs it
IDEAYA Biosciences
Where
Ann Arbor, Aurora, Austin, Baltimore, Boston, Cleveland, Columbus, Dallas, Englewood, Fishersville, Grand Rapids, Houston, Jacksonville, La Jolla, Los Angeles, Madison, Nashville, New York, Oklahoma City, Omaha, Orange, Palo Alto, Philadelphia, Pittsburgh, Riverside, Rochester, San Francisco, Scottsdale, and Tampa, United StatesSee the 35 sitesAlso in 20 other countries, 56 sites
Registry title
Neoadjuvant Darovasertib in Primary Uveal Melanoma
Status
Recruiting
Phase
Phase 3
People taking part
520 people, planned
Started
25 Jan 2026
Expected to end
Mar 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Darovasertib
  • Primary Local Therapy
Record updated
6 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with uveal melanoma (a cancer of the eye) that has not spread, who have not yet been treated for it.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
Primary uveal melanoma that has not spread (non-metastatic).
Earlier treatment
No previous treatment for uveal melanoma.

Main reasons for not taking part

  • Previous treatment for uveal melanoma
  • Signs that the uveal melanoma has spread
  • Eye problems that mean the eye must be removed whatever the response to therapy
  • Another worsening eye disease that would confuse the vision tests
  • Another cancer besides the one treated in this trial

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Previous treatment for 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
  • Evidence of metastatic UM

Where in United States

Also in 20 other countries, 56 sites

  • W Kellogg Eye CenterAnn Arbor, United StatesContact: Hakan Demirci, MD Principal InvestigatorNot yet recruiting
  • University of Colorado HospitalAurora, United StatesContact: Sapna Patel, MD Principal InvestigatorTaking people
  • Austin Retina Associates - CentralAustin, United StatesContact: Shelley Ghafoori, MD Principal InvestigatorTaking people
  • Wilmer Eye InstituteBaltimore, United StatesContact: James Handa, MD Principal InvestigatorTaking people
  • Massachusetts General HospitalBoston, United StatesContact: Kamaneh Montazeri, MD Principal InvestigatorNot yet recruiting
  • Cole Eye Institute-9500 Euclid AveCleveland, United StatesContact: Lucy Kennedy, MD Principal InvestigatorNot yet recruiting
  • Ohio State Eye and Ear InstituteColumbus, United StatesContact: Colleen Cebulla, MD Principal InvestigatorNot yet recruiting
  • Texas Retina Associates - DallasDallas, United StatesContact: Timothy Fuller, MD Principal InvestigatorTaking people
  • University of Texas Southwestern Medical Center-5323 Harry Hines BlvdDallas, United StatesContact: Sanjay Chandrasekaran, MD Principal InvestigatorTaking people
  • The Melanoma and Skin Cancer InstituteEnglewood, United StatesContact: Ryan Weight, MD Principal InvestigatorNot yet recruiting
  • Augusta Health Center for Cancer and Blood DisordersFishersville, United StatesContact: Kelvin Rayborn, MD Principal InvestigatorNot yet recruiting
  • The Cancer and Hematology Centers of West Michigan (CHCWM)Grand Rapids, United StatesContact: Sreenivasa Chandana, MD Principal InvestigatorTaking people
  • Retina Consultants of Texas - (Houston)Houston, United StatesContact: Amy Schefler, MD Principal InvestigatorNot yet recruiting
  • Mayo Clinic- JacksonvilleJacksonville, United StatesContact: Bently Doonan, MD Principal InvestigatorTaking people
  • UCSD Moores Cancer CenterLa Jolla, United StatesContact: Gregory Daniels, MD Principal InvestigatorNot yet recruiting
  • Jules Stein Eye InstituteLos Angeles, United StatesContact: Tara McCannel, MD Principal InvestigatorNot yet recruiting
  • USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesContact: Gino In, MD, Principal InvestigatorNot yet recruiting
  • University of Wisconsin HealthMadison, United StatesContact: Michael Altaweel, MD Principal InvestigatorNot yet recruiting
  • SCRI Oncology PartnersNashville, United StatesContact: Meredith McKean, MD Principal InvestigatorTaking people
  • Vanderbilt Eye InstituteNashville, United StatesContact: Paul Sternberg, MD, Principal InvestigatorNot yet recruiting
  • Herbert Irving Comprehensive Cancer CenterNew York, United StatesContact: Benjamin Izar, MD Principal InvestigatorTaking people
  • Memorial Sloan Kettering Cancer Center - 1275 York AveNew York, United StatesContact: Jasmine Francis, MD Principal InvestigatorNot yet recruiting
  • Northwell Health Cancer InstituteNew York, United StatesContact: Shaheer Khan, MD Principal InvestigatorNot yet recruiting
  • Retina Consultants of OklahomaOklahoma City, United StatesContact: Brian Firestone, MD, Principal InvestigatorNot yet recruiting
  • TIERING PercentilesOmaha, United StatesContact: Pukhraj Rishi, MD Principal InvestigatorNot yet recruiting
  • University of California Irvine Medical CenterOrange, United StatesContact: Poorva Vaidya, MD Principal InvestigatorNot yet recruiting
  • Stanford Comprehensive Cancer CenterPalo Alto, United StatesContact: Pauline Funchain, MD Principal InvestigatorTaking people
  • Jefferson Health Honickman CenterPhiladelphia, United StatesContact: Marlana Orloff, MD Principal InvestigatorNot yet recruiting
  • UPMC Hillman Cancer CenterPittsburgh, United StatesContact: Yana Najjar, MD Principal InvestigatorNot yet recruiting
  • Kaiser Permanente Riverside Medical CenterRiverside, United StatesContact: Helen Moon, MD Principal InvestigatorTaking people
  • Mayo Clinic - PPDSRochester, United StatesContact: Lauren Dalvin, MD Principal InvestigatorTaking people
  • UCSF Wayne and Gladys Valley Center for VisionSan Francisco, United StatesContact: Armin Afshar, MD, Principal InvestigatorNot yet recruiting
  • Mayo Clinic Scottsdale - PPDSScottsdale, United StatesContact: Odette Houghton, MD Principal InvestigatorTaking people
  • Moffit Cancer CenterTampa, United StatesContact: Nikhil Khushalani, MD, Principal InvestigatorNot yet recruiting
  • USF Health Eye InstituteTampa, United StatesContact: Jorge Agi, MD Principal InvestigatorNot yet recruiting

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Treatment ArmTreatment being tested

    Darovasetib followed by definitive primary local therapy (i.e., PB, proton beam radiation, or enucleation)

    Treatment: Darovasertib

  • Control ArmExisting treatment, for comparison

    Immediate Primary Local therapy

    Treatment: Primary Local Therapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)
Plain-language title
Tests darovasertib before surgery or radiation for uveal melanomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
6 May 2026