NCT07015190RecruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 520 (estimated)
- First submitted
- 3 Jun 2025
- Start date
- 25 Jan 2026
- Primary completion date
- 31 Oct 2030
- Lead sponsor
- IDEAYA Biosciences
- Diseases
- Melanoma
- NCT number
- NCT07015190
- EU CT number
- 2025-522387-32-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 520
- From 25 Jan 2026 to the primary completion date, 31 Oct 2030
- 91 sites in 21 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment for UM
- Attributes that necessitate enucleation regardless of response to therapy
Other illness
- 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
Other
- Evidence of metastatic UM
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (91)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Gallipoli Medical Research Foundation Coordinator of this site? Confirm its status | Greenslopes | Australia | Not yet recruiting |
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Not yet recruiting |
| The Crown Princess Mary Cancer Centre (Westmead Hospital), NSW 214 Coordinator of this site? Confirm its status | Westmead | Australia | Not yet recruiting |
| The Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Woodville South | Australia | Not yet recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Not yet recruiting |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Universitätsspital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Universitätsspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha Coordinator of this site? Confirm its status | Prague 6 | Czechia | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Staedtisches Klinikum Dessau Coordinator of this site? Confirm its status | Dessau-Rosslau | Germany | Recruiting |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Recruiting |
| Philipps-Universitaet Marburg Coordinator of this site? Confirm its status | Marburg | Germany | Recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| East Tallinn Central Hospital-Pärnu road 104 Coordinator of this site? Confirm its status | Tallinn | Estonia | Not yet recruiting |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Provincial de Conxo Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Centre Hospitalier National d'Ophtalmologie des Quize-Vingts Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| University College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Clatterbridge Cancer Centre - Liverpool - NWCRN - PPDS Coordinator of this site? Confirm its status | Metropolitan Borough of Wirral | United Kingdom | Not yet recruiting |
| Weston Park Cancer Centre - PPDS Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Not yet recruiting |
| PAGNI-University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Not yet recruiting |
| University General Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Not yet recruiting |
| AHEPA University General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Not yet recruiting |
| Hadassah Medical Center PPDS - Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| The Chaim Sheba Medical Center - PPDS Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
| Auckland Eye Coordinator of this site? Confirm its status | Auckland | New Zealand | Not yet recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Not yet recruiting |
| Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Institute of Oncology Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Not yet recruiting |
| Fakultna nemocnica s poliklinikou F.D.Roosevelta Coordinator of this site? Confirm its status | Banská Bystrica | Slovakia | Not yet recruiting |
| W Kellogg Eye Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Not yet recruiting |
| University of Colorado Hospital Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Austin Retina Associates - Central Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Wilmer Eye Institute Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Not yet recruiting |
| Cole Eye Institute-9500 Euclid Ave Coordinator of this site? Confirm its status | Cleveland | United States | Not yet recruiting |
| Ohio State Eye and Ear Institute Coordinator of this site? Confirm its status | Columbus | United States | Not yet recruiting |
| Texas Retina Associates - Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| University of Texas Southwestern Medical Center-5323 Harry Hines Blvd Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| The Melanoma and Skin Cancer Institute Coordinator of this site? Confirm its status | Englewood | United States | Not yet recruiting |
| Augusta Health Center for Cancer and Blood Disorders Coordinator of this site? Confirm its status | Fishersville | United States | Not yet recruiting |
| The Cancer and Hematology Centers of West Michigan (CHCWM) Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| Retina Consultants of Texas - (Houston) Coordinator of this site? Confirm its status | Houston | United States | Not yet recruiting |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| UCSD Moores Cancer Center Coordinator of this site? Confirm its status | La Jolla | United States | Not yet recruiting |
| Jules Stein Eye Institute Coordinator of this site? Confirm its status | Los Angeles | United States | Not yet recruiting |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Not yet recruiting |
| University of Wisconsin Health Coordinator of this site? Confirm its status | Madison | United States | Not yet recruiting |
| Vanderbilt Eye Institute Coordinator of this site? Confirm its status | Nashville | United States | Not yet recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Herbert Irving Comprehensive Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center - 1275 York Ave Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| Northwell Health Cancer Institute Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| Retina Consultants of Oklahoma Coordinator of this site? Confirm its status | Oklahoma City | United States | Not yet recruiting |
| TIERING Percentiles Coordinator of this site? Confirm its status | Omaha | United States | Not yet recruiting |
| University of California Irvine Medical Center Coordinator of this site? Confirm its status | Orange | United States | Not yet recruiting |
| Stanford Comprehensive Cancer Center Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Jefferson Health Honickman Center Coordinator of this site? Confirm its status | Philadelphia | United States | Not yet recruiting |
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Not yet recruiting |
| Kaiser Permanente Riverside Medical Center Coordinator of this site? Confirm its status | Riverside | United States | Recruiting |
| Mayo Clinic - PPDS Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| UCSF Wayne and Gladys Valley Center for Vision Coordinator of this site? Confirm its status | San Francisco | United States | Not yet recruiting |
| Mayo Clinic Scottsdale - PPDS Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| Moffit Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Not yet recruiting |
| USF Health Eye Institute Coordinator of this site? Confirm its status | Tampa | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.