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)
1 other identifier
interventional
520
18 countries
83
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2026
Longer than P75 for phase_3
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2025
CompletedFirst Posted
Study publicly available on registry
June 11, 2025
CompletedStudy Start
First participant enrolled
January 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2031
May 6, 2026
September 1, 2025
4.7 years
June 3, 2025
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm
Loss of Best Corrected Visual Acuity (BCVA) of ≥ 15 letters using Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA
Approximately 3 years
Cohort 2: To demonstrate the ability to salvage the eye and prevent enucleation in the Treatment Arm
Eye preservation rate
Approximately 2 years
Study Arms (2)
Treatment Arm
EXPERIMENTALDarovasetib followed by definitive primary local therapy (i.e., PB, proton beam radiation, or enucleation)
Control Arm
ACTIVE COMPARATORImmediate Primary Local therapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (94)
Mayo Clinic Scottsdale - PPDS
Scottsdale, Arizona, 85259, United States
UCSD Moores Cancer Center
La Jolla, California, 92093, United States
Jules Stein Eye Institute
Los Angeles, California, 90024, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
Stanford Comprehensive Cancer Center
Palo Alto, California, 94304, United States
Kaiser Permanente-Riverside Medical Center
Riverside, California, 92505-3043, United States
UCSF Wayne and Gladys Valley Center for Vision
San Francisco, California, 94143, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113-2791, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
USF Health Eye Institute
Tampa, Florida, 33612-6601, United States
Moffit Cancer Center
Tampa, Florida, 33612, United States
Wilmer Eye Institute
Baltimore, Maryland, 21287-0005, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
W Kellogg Eye Center
Ann Arbor, Michigan, 48105, United States
The Cancer and Hematology Centers of West Michigan (CHCWM)
Grand Rapids, Michigan, 49503, United States
Mayo Clinic - PPDS
Rochester, Minnesota, 55905, United States
TIERING Percentiles
Omaha, Nebraska, 68105, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center - 1275 York Ave
New York, New York, 10065-6635, United States
Northwell Health Cancer Institute
New York, New York, 11042, United States
Cole Eye Institute-9500 Euclid Ave
Cleveland, Ohio, 44195, United States
Ohio State Eye and Ear Institute
Columbus, Ohio, 43212, United States
Retina Consultants of Oklahoma
Oklahoma City, Oklahoma, 73112, United States
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, 19107, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Vanderbilt Eye Institute
Nashville, Tennessee, 37232, United States
Austin Retina Associates - Central
Austin, Texas, 78705, United States
Texas Retina Associates - Dallas
Dallas, Texas, 75231, United States
University of Texas Southwestern Medical Center-5323 Harry Hines Blvd
Dallas, Texas, 75390-9057, United States
Retina Consultants of Texas - (Houston)
Houston, Texas, 77030-2727, United States
Augusta Health, Center for Cancer and Blood Disorders
Fishersville, Virginia, 22939, United States
University of Wisconsin Health
Madison, Wisconsin, 53705-3644, United States
Gallipoli Medical Research Foundation
Greenslopes, Queensland, QLD 4120, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
The Crown Princess Mary Cancer Centre (Westmead Hospital), NSW 214
Westmead, NSW 2145, Australia
LKH-Universitätsklinikum Graz
Graz, 8036, Austria
Universitätsklinikum Innsbruck
Innsbruck, 6020, Austria
Universitätsklinikum AKH Wien
Vienna, 1090, Austria
Cliniques Universitaires Saint-Luc - PPDS
Brussels, 1200, Belgium
UZ Leuven - PPDS
Leuven, 3000, Belgium
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha
Prague, Prague, 169 02, Czechia
Rigshospitalet
Copenhagen O, Capital, 2100, Denmark
Aarhus Universitetshospital
Aarhus, Central Jutland, 8200, Denmark
East Tallinn Central Hospital-Pärnu road 104
Tallinn, Harju, 11312, Estonia
CHU de Nice-Hôpital Pasteur
Nice, Alpes-Maritimes, 6000, France
Centre Retine Gallien - Bordeaux
Bordeaux, Gironde, 33000, France
CHU de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, 35000, France
Institut Curie - Hôpital de Paris
Paris, Paris, 75248, France
Centre Hospitalier National D'ophtalmologie Des Quinze Vingts
Paris, 75571, France
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89075, Germany
Hautklinik Erlangen
Erlangen, Bavaria, 91054, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147, Germany
Städtisches Klinikum Dessau
Dessau, Saxony-Anhalt, 6847, Germany
Charité - Universitätsmedizin Berlin
Berlin, 12203, Germany
Universitätsklinikum Bonn
Bonn, 53127, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, 23562, Germany
Universitätsklinikum Giessen und Marburg - Marburg (UKGM)
Marburg, 35043, Germany
Universitätsklinikum Würzburg
Würzburg, 97080, Germany
PAGNI-University General Hospital of Heraklion
Heraklion, Irakleio, 715 00, Greece
University General Hospital of Larissa
Larissa, Larissa, 41 110, Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, Thessaloníki, 546 36, Greece
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Central District, 5262100, Israel
Hadassah Medical Center - PPDS
Jerusalem, Jerusalem, 91120, Israel
Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
Naples, Campania, 80131, Italy
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
Milan, Milan, 20157, Italy
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Perugia, Perugia, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134, Italy
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Pisa, 56124, Italy
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome, 168, Italy
Erasmus MC
Rotterdam, South Holland, 3015 GD, Netherlands
Auckland Eye
Auckland, Auckland, 1050, New Zealand
Uniwersytecki Szpital Kliniczny w Poznaniu- Dluga 1/2
Poznan, Greater Poland Voivodeship, 61-848, Poland
WIM-PIB, Centralny Szpital Kliniczny MON
Warsaw, Masovian Voivodeship, 04-141, Poland
Uniwersyteckie Centrum Kliniczne w Gdansku - Debinki 7
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Fakultna nemocnica s poliklinikou F. D. Roosevelta
Banská Bystrica, 975 17, Slovakia
Institute of Oncology Ljubljana
Ljubljana, Ljubljana, 1000, Slovenia
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 8907, Spain
Clinica Universidad Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Valencia, 46026, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Valladolid, 47003, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Universitätsspital Basel
Basel, 4031, Switzerland
Universitätsspital Zürich
Zurich, 8091, Switzerland
Clatterbridge Cancer Centre - Liverpool - NWCRN - PPDS
Metropolitan Borough of Wirral, Merseyside, CH63 4JY, United Kingdom
University College Hospital
London, NW1 2BU, United Kingdom
Weston Park Cancer Centre - PPDS
Sheffield, S10 2TF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2025
First Posted
June 11, 2025
Study Start
January 25, 2026
Primary Completion (Estimated)
October 1, 2030
Study Completion (Estimated)
March 1, 2031
Last Updated
May 6, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share