RecruitingPhase 3NCT07015190

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)

Sponsor

IDEAYA Biosciences

Enrollment

520 participants

Start Date

Jan 25, 2026

Study Type

INTERVENTIONAL

Conditions

Uveal Melanoma

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)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing darovasertib, a targeted drug, as a treatment given before the main treatment (such as eye surgery or radiation) in people with uveal melanoma — a rare type of eye cancer — to see if it can shrink tumors and possibly preserve vision. **You may be eligible if...** - You have been diagnosed with primary uveal (eye) melanoma that has not spread to other parts of the body - You have not had any prior treatment for this eye cancer - You are in good general health (ECOG 0 or 1) - Your organ function is adequate **You may NOT be eligible if...** - Your uveal melanoma has already spread (metastasized) - You have had any previous treatment for uveal melanoma - You have another active cancer - You have a progressive eye disease unrelated to the melanoma that could affect vision assessments - Doctors believe you need your eye removed regardless of treatment response Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDarovasertib

Dosed orally, twice daily (28-day/ cycle

PROCEDUREPrimary 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

View Full Details on ClinicalTrials.gov

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NCT07015190

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