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Neoadjuvant Darovasertib in Primary Uveal Melanoma

NCT07015190 · IDEAYA Biosciences
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Official title
A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)
About this study
The study is divided into 2 cohorts of patients with primary uveal melanoma requiring either plaque brachytherapy or enucleation. In cohort 1, patients in the treatment arm will receive neoadjuvant darovasertib followed by plaque brachytherapy compared to immediate plaque brachytherapy (control arm). In cohort 2, the treatment arm will receive neoadjuvant darovasertib followed by definitive primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation). Subjects in the control arm will go onto immediate enucleation. Subjects will then receive primary local therapy following neoadjuvant darovasertib. All patients will be followed for up to 3 years to assess longer term outcomes such as vision and tumor recurrence.
Eligibility criteria
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 target: 520 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-01-25
Estimated completion: 2031-03
Last updated: 2026-02-18
Interventions
Drug: DarovasertibProcedure: Primary Local Therapy
Primary outcomes
  • Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm (Approximately 3 years)
  • Cohort 2: To demonstrate the ability to salvage the eye and prevent enucleation in the Treatment Arm (Approximately 2 years)
Sponsor
IDEAYA Biosciences · industry
Contacts & investigators
ContactIDEAYA Clinical Trials · contact · IDEAYAClinicalTrials@ideayabio.com · +1-855-433-2246
ContactMwe Mwe Chao, MD · contact · mchao@ideayabio.com
All locations (87)
Mayo Clinic Scottsdale - PPDSNot Yet Recruiting
Scottsdale, Arizona, United States
UCSD Moores Cancer CenterNot Yet Recruiting
La Jolla, California, United States
Jules Stein Eye InstituteNot Yet Recruiting
Los Angeles, California, United States
University of California Irvine Medical CenterNot Yet Recruiting
Orange, California, United States
Stanford Comprehensive Cancer CenterNot Yet Recruiting
Palo Alto, California, United States
Kaiser Permanente-Riverside Medical CenterNot Yet Recruiting
Riverside, California, United States
University of Colorado HospitalNot Yet Recruiting
Aurora, Colorado, United States
The Melanoma and Skin Cancer InstituteNot Yet Recruiting
Englewood, Colorado, United States
Mayo Clinic JacksonvilleNot Yet Recruiting
Jacksonville, Florida, United States
USF Health Eye InstituteNot Yet Recruiting
Tampa, Florida, United States
Wilmer Eye InstituteNot Yet Recruiting
Baltimore, Maryland, United States
Massachusetts General HospitalNot Yet Recruiting
Boston, Massachusetts, United States
W Kellogg Eye CenterNot Yet Recruiting
Ann Arbor, Michigan, United States
The Cancer and Hematology Centers of West Michigan (CHCWM)Recruiting
Grand Rapids, Michigan, United States
Mayo Clinic - PPDSNot Yet Recruiting
Rochester, Minnesota, United States
TIERING PercentilesNot Yet Recruiting
Omaha, Nebraska, United States
Herbert Irving Comprehensive Cancer CenterWithdrawn
New York, New York, United States
Memorial Sloan Kettering Cancer Center - 1275 York AveNot Yet Recruiting
New York, New York, United States
Northwell Health Cancer InstituteNot Yet Recruiting
New York, New York, United States
Cole Eye Institute-9500 Euclid AveNot Yet Recruiting
Cleveland, Ohio, United States
Ohio State Eye and Ear InstituteNot Yet Recruiting
Columbus, Ohio, United States
Jefferson Health Honickman CenterNot Yet Recruiting
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer CenterNot Yet Recruiting
Pittsburgh, Pennsylvania, United States
Southeastern Retina Associates-HixsonWithdrawn
Hixson, Tennessee, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Austin Retina Associates - CentralRecruiting
Austin, Texas, United States
Texas Retina Associates - DallasRecruiting
Dallas, Texas, United States
University of Texas Southwestern Medical Center-5323 Harry Hines BlvdNot Yet Recruiting
Dallas, Texas, United States
Retina Consultants of Texas - (Houston)Not Yet Recruiting
Houston, Texas, United States
Augusta Health, Center for Cancer and Blood DisordersNot Yet Recruiting
Fishersville, Virginia, United States
University of Wisconsin HealthNot Yet Recruiting
Madison, Wisconsin, United States
The Queen Elizabeth HospitalNot Yet Recruiting
Woodville South, South Australia, Australia
The Alfred HospitalNot Yet Recruiting
Melbourne, Victoria, Australia
LKH-Universitätsklinikum GrazNot Yet Recruiting
Graz, Austria
Universitätsklinikum InnsbruckNot Yet Recruiting
Innsbruck, Austria
Universitätsklinikum AKH WienNot Yet Recruiting
Vienna, Austria
Cliniques Universitaires Saint-Luc - PPDSNot Yet Recruiting
Brussels, Belgium
UZ Leuven - PPDSNot Yet Recruiting
Leuven, Belgium
Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Ustredni vojenska nemocnice - Vojenska fakultni nemocnice PrahaNot Yet Recruiting
Prague, Prague, Czechia
RigshospitaletNot Yet Recruiting
Copenhagen O, Capital, Denmark
Aarhus UniversitetshospitalNot Yet Recruiting
Aarhus, Central Jutland, Denmark
East Tallinn Central Hospital-Pärnu road 104Not Yet Recruiting
Tallinn, Harju, Estonia
CHU de Nice-Hôpital PasteurNot Yet Recruiting
Nice, Alpes-Maritimes, France
Centre Retine Gallien - BordeauxNot Yet Recruiting
Bordeaux, Gironde, France
CHU de Rennes - Hôpital PontchaillouNot Yet Recruiting
Rennes, Ille-et-Vilaine, France
Institut Curie - Hôpital de ParisNot Yet Recruiting
Paris, Paris, France
Centre Hospitalier National D'ophtalmologie Des Quinze VingtsNot Yet Recruiting
Paris, France
Universitätsklinikum TübingenNot Yet Recruiting
Tübingen, Baden-Wurttemberg, Germany
Universitätsklinikum UlmNot Yet Recruiting
Ulm, Baden-Wurttemberg, Germany
Hautklinik ErlangenNot Yet Recruiting
Erlangen, Bavaria, Germany
Universitätsklinikum EssenNot Yet Recruiting
Essen, North Rhine-Westphalia, Germany
Städtisches Klinikum DessauNot Yet Recruiting
Dessau, Saxony-Anhalt, Germany
Charité - Universitätsmedizin BerlinNot Yet Recruiting
Berlin, Germany
Universitätsklinikum BonnNot Yet Recruiting
Bonn, Germany
Universitätsklinikum Schleswig-Holstein - Campus LübeckNot Yet Recruiting
Lübeck, Germany
Universitätsklinikum Giessen und Marburg - Marburg (UKGM)Not Yet Recruiting
Marburg, Germany
Universitätsklinikum WürzburgNot Yet Recruiting
Würzburg, Germany
PAGNI-University General Hospital of HeraklionNot Yet Recruiting
Heraklion, Irakleio, Greece
University General Hospital of LarissaNot Yet Recruiting
Larissa, Larissa, Greece
AHEPA University General Hospital of ThessalonikiNot Yet Recruiting
Thessaloniki, Thessaloníki, Greece
The Chaim Sheba Medical Center - PPDSRecruiting
Ramat Gan, Central District, Israel
Hadassah Medical Center - PPDSRecruiting
Jerusalem, Jerusalem, Israel
Istituto Nazionale Tumori IRCCS Fondazione Giovanni PascaleNot Yet Recruiting
Naples, Campania, Italy
ASST Fatebenefratelli Sacco - Ospedale Luigi SaccoNot Yet Recruiting
Milan, Milan, Italy
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della MisericordiaNot Yet Recruiting
Perugia, Perugia, Italy
Azienda Ospedaliera Universitaria CareggiNot Yet Recruiting
Florence, Tuscany, Italy
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della MisericordiaNot Yet Recruiting
Pisa, Italy
Fondazione Policlinico Universitario A Gemelli - Rome - PPDSNot Yet Recruiting
Rome, Italy
Erasmus MCNot Yet Recruiting
Rotterdam, South Holland, Netherlands
Auckland EyeNot Yet Recruiting
Auckland, Auckland, New Zealand
Uniwersytecki Szpital Kliniczny w Poznaniu- Dluga 1/2Not Yet Recruiting
Poznan, Greater Poland Voivodeship, Poland
WIM-PIB, Centralny Szpital Kliniczny MONNot Yet Recruiting
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne w Gdansku - Debinki 7Not Yet Recruiting
Gdansk, Pomeranian Voivodeship, Poland
Fakultna nemocnica s poliklinikou F. D. RooseveltaNot Yet Recruiting
Banská Bystrica, Slovakia
Institute of Oncology LjubljanaNot Yet Recruiting
Ljubljana, Ljubljana, Slovenia
Hospital Clinico Universitario de SantiagoNot Yet Recruiting
Santiago de Compostela, A Coruña, Spain
Hospital Universitario de BellvitgeNot Yet Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Clinica Universidad NavarraNot Yet Recruiting
Pamplona, Navarre, Spain
Hospital Universitari i Politecnic La Fe de ValenciaNot Yet Recruiting
Valencia, Valencia, Spain
Hospital Clinico Universitario de ValladolidNot Yet Recruiting
Valladolid, Valladolid, Spain
Hospital Universitario Virgen MacarenaNot Yet Recruiting
Seville, Spain
Universitätsspital BaselNot Yet Recruiting
Basel, Switzerland
Universitätsspital ZürichNot Yet Recruiting
Zurich, Switzerland
Clatterbridge Cancer Centre - Liverpool - NWCRN - PPDSNot Yet Recruiting
Metropolitan Borough of Wirral, Merseyside, United Kingdom
University College HospitalNot Yet Recruiting
London, United Kingdom
Weston Park Cancer Centre - PPDSNot Yet Recruiting
Sheffield, United Kingdom
Neoadjuvant Darovasertib in Primary Uveal Melanoma · TrialPath