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NCT07015190RecruitingPhase 3

Neoadjuvant Darovasertib in Primary Uveal Melanoma

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

Source: ClinicalTrials.gov · Last updated 6 May 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
520 (estimated)
First submitted
3 Jun 2025
Start date
25 Jan 2026
Primary completion date
31 Oct 2030
Lead sponsor
IDEAYA Biosciences
Diseases
Melanoma
NCT number
NCT07015190
EU CT number
2025-522387-32-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 520
  • From 25 Jan 2026 to the primary completion date, 31 Oct 2030
  • 91 sites in 21 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous treatment for UM
  • Attributes that necessitate enucleation regardless of response to therapy

Other illness

  • 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

Other

  • Evidence of metastatic UM

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (91)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Graz
Coordinator of this site? Confirm its status
GrazAustriaRecruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Gallipoli Medical Research Foundation
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GreenslopesAustraliaNot yet recruiting
The Alfred Hospital
Coordinator of this site? Confirm its status
MelbourneAustraliaNot yet recruiting
The Crown Princess Mary Cancer Centre (Westmead Hospital), NSW 214
Coordinator of this site? Confirm its status
WestmeadAustraliaNot yet recruiting
The Queen Elizabeth Hospital
Coordinator of this site? Confirm its status
Woodville SouthAustraliaNot yet recruiting
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumRecruiting
Cliniques Universitaires Saint-Luc
Coordinator of this site? Confirm its status
Sint-Lambrechts-WoluweBelgiumRecruiting
Cross Cancer Institute
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EdmontonCanadaNot yet recruiting
Princess Margaret Cancer Centre
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TorontoCanadaRecruiting
Universitätsspital Basel
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BaselSwitzerlandRecruiting
Universitätsspital Zürich
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ZurichSwitzerlandRecruiting
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha
Coordinator of this site? Confirm its status
Prague 6CzechiaRecruiting
Charite Universitaetsmedizin Berlin KöR
Coordinator of this site? Confirm its status
BerlinGermanyRecruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyRecruiting
Staedtisches Klinikum Dessau
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Dessau-RosslauGermanyRecruiting
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein AöR
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LuebeckGermanyRecruiting
Philipps-Universitaet Marburg
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MarburgGermanyRecruiting
Universitaet Muenster
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MuensterGermanyRecruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyRecruiting
Region Midtjylland
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Aarhus NDenmarkRecruiting
Rigshospitalet
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Copenhagen OeDenmarkRecruiting
East Tallinn Central Hospital-Pärnu road 104
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TallinnEstoniaNot yet recruiting
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainRecruiting
Clínica Universidad de navarra
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PamplonaSpainRecruiting
Hospital Provincial de Conxo
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Santiago de CompostelaSpainRecruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainRecruiting
Hospital Clínico Universitario de Valladolid
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ValladolidSpainRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Centre Hospitalier National d'Ophtalmologie des Quize-Vingts
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ParisFranceRecruiting
Institut Curie
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ParisFranceRecruiting
University College Hospital
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LondonUnited KingdomNot yet recruiting
Clatterbridge Cancer Centre - Liverpool - NWCRN - PPDS
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Metropolitan Borough of WirralUnited KingdomNot yet recruiting
Weston Park Cancer Centre - PPDS
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SheffieldUnited KingdomNot yet recruiting
PAGNI-University General Hospital of Heraklion
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HeraklionGreeceNot yet recruiting
University General Hospital of Larissa
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LarissaGreeceNot yet recruiting
AHEPA University General Hospital of Thessaloniki
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ThessalonikiGreeceNot yet recruiting
Hadassah Medical Center PPDS -
Coordinator of this site? Confirm its status
JerusalemIsraelRecruiting
The Chaim Sheba Medical Center - PPDS
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Ramat GanIsraelRecruiting
Azienda Ospedaliero-Universitaria Careggi
Coordinator of this site? Confirm its status
FlorenceItalyRecruiting
ASST Fatebenefratelli Sacco
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MilanItalyRecruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyRecruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Coordinator of this site? Confirm its status
NaplesItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsNot yet recruiting
Auckland Eye
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AucklandNew ZealandNot yet recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandNot yet recruiting
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
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WarsawPolandNot yet recruiting
Institute of Oncology Ljubljana
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LjubljanaSloveniaNot yet recruiting
Fakultna nemocnica s poliklinikou F.D.Roosevelta
Coordinator of this site? Confirm its status
Banská BystricaSlovakiaNot yet recruiting
W Kellogg Eye Center
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Ann ArborUnited StatesNot yet recruiting
University of Colorado Hospital
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AuroraUnited StatesRecruiting
Austin Retina Associates - Central
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AustinUnited StatesRecruiting
Wilmer Eye Institute
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BaltimoreUnited StatesRecruiting
Massachusetts General Hospital
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BostonUnited StatesNot yet recruiting
Cole Eye Institute-9500 Euclid Ave
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ClevelandUnited StatesNot yet recruiting
Ohio State Eye and Ear Institute
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ColumbusUnited StatesNot yet recruiting
Texas Retina Associates - Dallas
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
University of Texas Southwestern Medical Center-5323 Harry Hines Blvd
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
The Melanoma and Skin Cancer Institute
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EnglewoodUnited StatesNot yet recruiting
Augusta Health Center for Cancer and Blood Disorders
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FishersvilleUnited StatesNot yet recruiting
The Cancer and Hematology Centers of West Michigan (CHCWM)
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Grand RapidsUnited StatesRecruiting
Retina Consultants of Texas - (Houston)
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HoustonUnited StatesNot yet recruiting
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesRecruiting
UCSD Moores Cancer Center
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La JollaUnited StatesNot yet recruiting
Jules Stein Eye Institute
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Los AngelesUnited StatesNot yet recruiting
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesNot yet recruiting
University of Wisconsin Health
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MadisonUnited StatesNot yet recruiting
Vanderbilt Eye Institute
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NashvilleUnited StatesNot yet recruiting
SCRI Oncology Partners
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NashvilleUnited StatesRecruiting
Herbert Irving Comprehensive Cancer Center
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New YorkUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center - 1275 York Ave
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New YorkUnited StatesNot yet recruiting
Northwell Health Cancer Institute
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New YorkUnited StatesNot yet recruiting
Retina Consultants of Oklahoma
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Oklahoma CityUnited StatesNot yet recruiting
TIERING Percentiles
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OmahaUnited StatesNot yet recruiting
University of California Irvine Medical Center
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OrangeUnited StatesNot yet recruiting
Stanford Comprehensive Cancer Center
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Palo AltoUnited StatesRecruiting
Jefferson Health Honickman Center
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PhiladelphiaUnited StatesNot yet recruiting
UPMC Hillman Cancer Center
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PittsburghUnited StatesNot yet recruiting
Kaiser Permanente Riverside Medical Center
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RiversideUnited StatesRecruiting
Mayo Clinic - PPDS
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RochesterUnited StatesRecruiting
UCSF Wayne and Gladys Valley Center for Vision
Coordinator of this site? Confirm its status
San FranciscoUnited StatesNot yet recruiting
Mayo Clinic Scottsdale - PPDS
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ScottsdaleUnited StatesRecruiting
Moffit Cancer Center
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TampaUnited StatesNot yet recruiting
USF Health Eye Institute
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TampaUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.