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Neoadjuvant Darovasertib in Primary Uveal Melanoma
Sponsor: IDEAYA Biosciences
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)
Official title: A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
520
Start Date
2026-01-25
Completion Date
2031-03
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
Darovasertib
Dosed orally, twice daily (28-day/ cycle
Primary Local Therapy
Plaque Brachytherapy or Enucleation
Locations (87)
Mayo Clinic Scottsdale - PPDS
Scottsdale, Arizona, United States
UCSD Moores Cancer Center
La Jolla, California, United States
Jules Stein Eye Institute
Los Angeles, California, United States
University of California Irvine Medical Center
Orange, California, United States
Stanford Comprehensive Cancer Center
Palo Alto, California, United States
Kaiser Permanente-Riverside Medical Center
Riverside, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
USF Health Eye Institute
Tampa, Florida, United States
Wilmer Eye Institute
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
W Kellogg Eye Center
Ann Arbor, Michigan, United States
The Cancer and Hematology Centers of West Michigan (CHCWM)
Grand Rapids, Michigan, United States
Mayo Clinic - PPDS
Rochester, Minnesota, United States
TIERING Percentiles
Omaha, Nebraska, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center - 1275 York Ave
New York, New York, United States
Northwell Health Cancer Institute
New York, New York, United States
Cole Eye Institute-9500 Euclid Ave
Cleveland, Ohio, United States
Ohio State Eye and Ear Institute
Columbus, Ohio, United States
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Southeastern Retina Associates-Hixson
Hixson, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Austin Retina Associates - Central
Austin, Texas, United States
Texas Retina Associates - Dallas
Dallas, Texas, United States
University of Texas Southwestern Medical Center-5323 Harry Hines Blvd
Dallas, Texas, United States
Retina Consultants of Texas - (Houston)
Houston, Texas, United States
Augusta Health, Center for Cancer and Blood Disorders
Fishersville, Virginia, United States
University of Wisconsin Health
Madison, Wisconsin, United States
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
LKH-Universitätsklinikum Graz
Graz, Austria
Universitätsklinikum Innsbruck
Innsbruck, Austria
Universitätsklinikum AKH Wien
Vienna, Austria
Cliniques Universitaires Saint-Luc - PPDS
Brussels, Belgium
UZ Leuven - PPDS
Leuven, Belgium
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha
Prague, Prague, Czechia
Rigshospitalet
Copenhagen O, Capital, Denmark
Aarhus Universitetshospital
Aarhus, Central Jutland, Denmark
East Tallinn Central Hospital-Pärnu road 104
Tallinn, Harju, Estonia
CHU de Nice-Hôpital Pasteur
Nice, Alpes-Maritimes, France
Centre Retine Gallien - Bordeaux
Bordeaux, Gironde, France
CHU de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, France
Institut Curie - Hôpital de Paris
Paris, Paris, France
Centre Hospitalier National D'ophtalmologie Des Quinze Vingts
Paris, France
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Hautklinik Erlangen
Erlangen, Bavaria, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Städtisches Klinikum Dessau
Dessau, Saxony-Anhalt, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Germany
Universitätsklinikum Giessen und Marburg - Marburg (UKGM)
Marburg, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
PAGNI-University General Hospital of Heraklion
Heraklion, Irakleio, Greece
University General Hospital of Larissa
Larissa, Larissa, Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, Thessaloníki, Greece
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Central District, Israel
Hadassah Medical Center - PPDS
Jerusalem, Jerusalem, Israel
Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
Naples, Campania, Italy
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
Milan, Milan, Italy
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Perugia, Perugia, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Pisa, Italy
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome, Italy
Erasmus MC
Rotterdam, South Holland, Netherlands
Auckland Eye
Auckland, Auckland, New Zealand
Uniwersytecki Szpital Kliniczny w Poznaniu- Dluga 1/2
Poznan, Greater Poland Voivodeship, Poland
WIM-PIB, Centralny Szpital Kliniczny MON
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne w Gdansku - Debinki 7
Gdansk, Pomeranian Voivodeship, Poland
Fakultna nemocnica s poliklinikou F. D. Roosevelta
Banská Bystrica, Slovakia
Institute of Oncology Ljubljana
Ljubljana, Ljubljana, Slovenia
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Clinica Universidad Navarra
Pamplona, Navarre, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Valencia, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Valladolid, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Universitätsspital Basel
Basel, Switzerland
Universitätsspital Zürich
Zurich, Switzerland
Clatterbridge Cancer Centre - Liverpool - NWCRN - PPDS
Metropolitan Borough of Wirral, Merseyside, United Kingdom
University College Hospital
London, United Kingdom
Weston Park Cancer Centre - PPDS
Sheffield, United Kingdom