Overview Study Design Endpoints Trial Locator

A phase 3, randomized, multicenter, open-label study1

NCT07015190

Currently open for enrollment

The trial at a glance

OptimUM-10 is designed to evaluate neoadjuvant darovasertib in patients with primary nonmetastatic uveal melanoma (UM).1

Patients with primary UM (N=450)1

COHORT 1

Patients requiring plaque brachytherapy1
Neoadjuvant darovasertib followed by plaque brachytherapy
Immediate plaque brachytherapy

COHORT 2

Patients requiring enucleation1
Neoadjuvant darovasertib followed by definitive primary local therapy*
Immediate enucleation

*Plaque brachytherapy, external beam radiation, or enucleation.1

Primary endpoints

Cohort 1

  • Loss of Best Corrected Visual Acuity (BCVA) of ≥15 letters using Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA1

Cohort 2

  • Eye preservation rate1
Checkmark

SELECT INCLUSION CRITERIA2

  • Age 18 years or older
  • Primary localized UM
  • High-risk for metastatic disease
  • Requiring either plaque brachytherapy (cohort 1) or enucleation (cohort 2)
  • High risk of visual impairment (cohort 1)
  • ECOG performance status ≤1
  • Adequate organ function
X Mark

SELECT EXCLUSION CRITERIA1,2

  • Previous treatment for UM
  • Evidence of metastatic UM
  • Prior PKC inhibitor treatment
  • Symptomatic or untreated CNS metastases
  • Significant underlying ocular disease
  • Attributes that necessitate enucleation regardless of response to therapy
  • Concurrent malignant disease

CNS, central nervous system; ECOG, Eastern Cooperative Oncology Group; PKC, protein kinase C.

Trial site locations

OptimUM-10 is available globally. Browse below to find the location nearest you.

South Australia, Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, 5011

Rachel Roberts-Thomson, MD

Principal Investigator

Victoria, Australia

The Alfred Hospital

Melbourne, Victoria 3004

Mark Shackleton, MD

Principal Investigator

Styria, Austria

LKH-Universitätsklinikum Graz

Graz 8036

Thomas Georgi, MD

Principal Investigator

Tyrol, Austria

Universitätsklinikum Innsbruck

Innsbruck 6020

Matus Rehak, MD

Principal Investigator

Vienna, Austria

Universitätsklinikum AKH Wien

Vienna 1090

Roman Dunavölgyi, MD

Principal Investigator

Brussels, Belgium

Cliniques Universitaires Saint Luc – PPDS

Brussels 1200

Jean-Francois Baurain, MD

Principal Investigator

Flanders, Belgium

UZ Leuven – PPDS

Leuven 3000

Joachim Van Calster, MD

Principal Investigator

Ontario, Canada

Princess Margaret Cancer Centre

Toronto M5G 2M9

Marcus Butler, MD

Principal Investigator

Prague, Czechia

Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha

Prague 169 02

Zuzana Hradcova, MD

Principal Investigator

Capital, Denmark

Rigshospitalet

Copenhagen 2100

Jens Kiilgaard, MD  Principal Investigator

Central Jutland, Denmark

Aarhus Universitetshospital

Aarhus 8200

Peter Skov Jensen, MD

Principal Investigator

London, England

University College London Hospital

London NW1 2BU

Heather Shaw, MD

Principal Investigator

Merseyside, England

Clatterbridge Cancer Centre - Liverpool - NWCRN – PPDS

Wirral, CH63 4JY

Joseph Sacco, MD

Principal Investigator

Harju, Estonia

East Tallinn Central Hospital

Elen Vettus, MD

Brittany, France

CHU de Rennes - Hopital Pontchaillou

Rennes 35000

Frederic Mouriaux, MD

Principal Investigator

Île-de-France, France

Institut Curie - Hôpital de Paris

Paris 75248

Alexandre Matet, MD

Principal Investigator

Nouvelle-Aquitaine, France

Centre Retine Gallien – Bordeaux

Bordeaux 33000

Laurence Rosier, MD

Principal Investigator

PACA, France

CHU de Nice-Hôpital Pasteur

Nice 6000

Sacha Nahon-Estève, MD

Principal Investigator

Baden-Württemberg, Germany

Universitätsklinikum Tübingen

Tübingen 72076

Daniela Süsskind, MD

Principal Investigator

Baden-Württemberg, Germany

Universitätsklinikum Ulm

Ulm 89075

Armin Wolf, MD

Principal Investigator

Bavaria, Germany

Universitätsklinikum Würzburg

Würzburg 97080

Andreas Berlin, MD

Principal Investigator

Berlin, Germany

Charité - Universitätsmedizin Berlin

Berlin 12203

Antonia Joussen, MD

Principal Investigator

Hesse, Germany

Universitätsklinikum Giessen und Marburg - Marburg (UKGM)

Marburg 35043

Walter Sekundo, MD

Principal Investigator

North Rhine-Westphalia, Germany

Universitätsklinikum Bonn

Bonn 53127

Thomas Ach, MD

Principal Investigator

North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen 45147

Halime Kalkavan, MD

Principal Investigator

Saxony-Anhalt, Germany

Städtisches Klinikum Dessau

Dessau 6847

Lothar Krause, MD

Principal Investigator

Schleswig-Holstein, Germany

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck 23562

Svenja Sonntag, MD

Principal Investigator

Crete, Greece

PAGNI-University General Hospital of Heraklion

Heraklion 715 00

Efstathios Detorakis, MD

Principal Investigator

Jerusalem District, Israel

Hadassah Medical Center – PPDS

Jerusalem 91120

Shahar Frenkel, MD

Principal Investigator

Tel Aviv District, Israel

The Chaim Sheba Medical Center – PPDS

Ramat Gan 5262100

Vicktoria Vishnevskia-Dai, MD

Principal Investigator

Campania, Italy

Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale

Naples 80131

Paolo Ascierto, MD

Principal Investigator

Lazio, Italy

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

Rome 168

Ernesto Rossi, MD

Principal Investigator

Lombardy, Italy

ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

Milan 20157

Marco Pellegrini, MD

Principal Investigator

Tuscany, Italy

Azienda Ospedaliera Universitaria Careggi

Florence 50134

Cinzia Mazzini, MD

Principal Investigator

Tuscany, Italy

Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia

Pisa 56124

Federica Genovesi Ebert

MD Principal Investigator

Umbria, Italy

Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia

Perugia Mario Mandalà, MD

Principal Investigator

South Holland, Netherlands

Erasmus MC

Rotterdam 3015 GD

Emine Kiliç-Ciğirci, MD

Principal Investigator

Pomeranian Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne w Gdansku - Debinki 7

Gdansk 80-214

Kamil Drucis, MD

Principal Investigator

Posen, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu- Dluga 1/2

Poznan 61-848

Iwona Rospond-Kubiak, MD

Principal Investigator

Warsaw, Poland

WIM-PIB, Centralny Szpital Kliniczny MON

Warsaw 04-141

Izabela Nowak-Gospodarowicz, MD

Principal Investigator

Andalusia, Spain

Hospital Universitario Virgen Macarena

Seville 41009

Francisco Espejo-Arjona, MD

Principal Investigator

Castile and León, Spain

Hospital Clinico Universitario de Valladolid

Ciro Garcia-Alvarez, MD

Principal Investigator

Catalonia, Spain

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona 8907

Jose Maria Caminal Mitjana, MD

Principal Investigator

Galicia, Spain

Hospital Clinico Universitario de Santiago

Santiago de Compostela, 15706

Maria José Blanco Teijeiro, MD

Principal Investigator

Navarra, Spain

Clinica Universidad Navarra

Pamplona 31008

Alfredo Garcia Layana, MD

Principal Investigator

Valencia, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia 46026

Rafael Martínez-Costa Pérez, MD

Principal Investigator

Basel, Switzerland

Universitätsspital Basel

Basel 4031

Alexandra Steinemann-Inauen, MD

Principal Investigator

Zurich, Switzerland

Universitätsspital Zürich

Zurich 8091

Egle Ramelyte, MD

Principal Investigator

Arizona, United States

Mayo Clinic Scottsdale – PPDS

Scottsdale, AZ 85259

Odette Houghton, MD

Principal Investigator

California, United States

UCSD Moores Cancer Center

La Jolla, CA 92093

Gregory Daniels, MD

Principal Investigator

California, United States

University of California Irvine Medical Center

Orange, CA 92868

Poorva Vaidya, MD

Principal Investigator

California, United States

Stanford Comprehensive Cancer Center

Palo Alto, CA 94304

Pauline Funchain, MD

Principal Investigator

California, United States

Kaiser Permanente-Riverside Medical Center

Riverside, CA 92505-3043

Helen Moon, MD

Principal Investigator

Colorado, United States

University of Colorado Hospital

Aurora, CO 80045

Sapna Patel, MD

Principal Investigator

Colorado, United States

The Melanoma and Skin Cancer Institute

Englewood, CO 80113-2791

Ryan Weight, MD

Principal Investigator

Florida, United States

Mayo Clinic Jacksonville

Jacksonville, FL 32224

Bently Doonan, MD

Principal Investigator

Maryland, United States

Wilmer Eye Institute

Baltimore, MD 21287-0005

James Handa, MD

Principal Investigator

Massachusetts, United States

Massachusetts Eye and Ear Infirmary

Boston, MA 02114

Ivana Kim, MD

Principal Investigator

Michigan, United States

W Kellogg Eye Center

Ann Arbor, MI 48105

Hakan Demirci, MD

Principal Investigator

Michigan, United States

The Cancer and Hematology Centers of West Michigan (CHCWM)

Grand Rapids, MI 49503

Sreenivasa Chandana, MD

Principal Investigator

Minnesota, United States

Mayo Clinic - PPDS

Rochester, MN 55905

Lauren Dalvin, MD

Principal Investigator

Nebraska, United States

TIERING Percentiles

Omaha, NE 68105

Pukhraj Rishi, MD

Principal Investigator

New York, United States

Herbert Irving Comprehensive Cancer Center

New York, NY 10032

Mariam El-Ashmawy, MD

Principal Investigator

New York, United States

Memorial Sloan Kettering Cancer Center

New York, NY 10065-6635

Jasmine Francis, MD

Principal Investigator

Ohio, United States

Cole Eye Institute

Cleveland, OH 44195

Lucy Kennedy, MD

Principal Investigator

Ohio, United States

Ohio State Eye and Ear Institute

Columbus, OH 43212

Colleen Cebulla, MD

Principal Investigator

Pennsylvania, United States

Jefferson Health Honickman Center

Philadelphia, PA 19107

Marlana Orloff, MD

Principal Investigator

Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, PA 15232

Yana Najjar, MD

Principal Investigator

Tennessee, United States

Southeastern Retina Associates-Hixson

Hixson, TN 37343

Asghar Haider, MD

Principal Investigator

Tennessee, United States

SCRI Oncology Partners

Nashville, TN 37203

Meredith McKean, MD

Principal Investigator

Texas, United States

Austin Retina Associates - Central

Austin, TX 78705

Shelley Ghafoori, MD

Principal Investigator

Texas, United States

Texas Retina Associates - Dallas

Dallas, TX 75231

Timothy Fuller, MD

Principal Investigator

Texas, United States

University of Texas Southwestern Medical Center

Dallas, TX 75390-9057

James Harbour, MD

Principal Investigator

Virginia, United States

Augusta Health, Center for Cancer and Blood Disorders

Fishersville, VA, 22939

Kelvin Rayborn, MD

Principal Investigator

Wisconsin, United States

University of Wisconsin Health

Madison, WI 53705-3644

Michael Altaweel, MD

Principal Investigator

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Darovasertib is an investigational product and has not been approved by the U.S. Food and Drug Administration for safety or effectiveness.

References: 1. Neoadjuvant darovasertib in primary uveal melanoma. ClinicalTrials.gov identifier: NCT07015190. Updated October 10, 2025. Accessed January 14, 2026. https://clinicaltrials.gov/study/NCT07015190 2. Data on file. Ideaya Biosciences, 2025.