A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)
Status: Recruiting
Location: See all (74) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Mayo Clinic Scottsdale - PPDS
NOT_YET_RECRUITING
Scottsdale
California
UCSD Moores Cancer Center
NOT_YET_RECRUITING
La Jolla
University of California Irvine Medical Center
NOT_YET_RECRUITING
Orange
Stanford Comprehensive Cancer Center
NOT_YET_RECRUITING
Palo Alto
Kaiser Permanente-Riverside Medical Center
NOT_YET_RECRUITING
Riverside
Colorado
University of Colorado Hospital
NOT_YET_RECRUITING
Aurora
The Melanoma and Skin Cancer Institute
NOT_YET_RECRUITING
Englewood
Florida
Mayo Clinic Jacksonville
NOT_YET_RECRUITING
Jacksonville
Massachusetts
Massachusetts Eye and Ear Infirmary
NOT_YET_RECRUITING
Boston
Maryland
Wilmer Eye Institute
NOT_YET_RECRUITING
Baltimore
Michigan
W Kellogg Eye Center
NOT_YET_RECRUITING
Ann Arbor
The Cancer and Hematology Centers of West Michigan (CHCWM)
NOT_YET_RECRUITING
Grand Rapids
Minnesota
Mayo Clinic - PPDS
NOT_YET_RECRUITING
Rochester
Nebraska
TIERING Percentiles
NOT_YET_RECRUITING
Omaha
New York
Herbert Irving Comprehensive Cancer Center
NOT_YET_RECRUITING
New York
Memorial Sloan Kettering Cancer Center - 1275 York Ave
NOT_YET_RECRUITING
New York
Ohio
Cole Eye Institute-9500 Euclid Ave
NOT_YET_RECRUITING
Cleveland
Ohio State Eye and Ear Institute
NOT_YET_RECRUITING
Columbus
Pennsylvania
Jefferson Health Honickman Center
NOT_YET_RECRUITING
Philadelphia
UPMC Hillman Cancer Center
NOT_YET_RECRUITING
Pittsburgh
Tennessee
Southeastern Retina Associates-Hixson
NOT_YET_RECRUITING
Hixson
SCRI Oncology Partners
NOT_YET_RECRUITING
Nashville
Texas
Austin Retina Associates - Central
NOT_YET_RECRUITING
Austin
Texas Retina Associates - Dallas
RECRUITING
Dallas
University of Texas Southwestern Medical Center-5323 Harry Hines Blvd
NOT_YET_RECRUITING
Dallas
Virginia
Augusta Health, Center for Cancer and Blood Disorders
NOT_YET_RECRUITING
Fishersville
Wisconsin
University of Wisconsin Health
NOT_YET_RECRUITING
Madison
Other Locations
Australia
The Alfred Hospital
NOT_YET_RECRUITING
Melbourne
The Queen Elizabeth Hospital
NOT_YET_RECRUITING
Woodville South
Austria
LKH-Universitätsklinikum Graz
NOT_YET_RECRUITING
Graz
Universitätsklinikum Innsbruck
NOT_YET_RECRUITING
Innsbruck
Universitätsklinikum AKH Wien
NOT_YET_RECRUITING
Vienna
Belgium
Cliniques Universitaires Saint-Luc - PPDS
NOT_YET_RECRUITING
Brussels
UZ Leuven - PPDS
NOT_YET_RECRUITING
Leuven
Canada
Princess Margaret Cancer Centre
NOT_YET_RECRUITING
Toronto
Denmark
Aarhus Universitetshospital
NOT_YET_RECRUITING
Aarhus
Rigshospitalet
NOT_YET_RECRUITING
Copenhagen O
Estonia
East Tallinn Central Hospital-Pärnu road 104
NOT_YET_RECRUITING
Tallinn
France
Centre Retine Gallien - Bordeaux
NOT_YET_RECRUITING
Bordeaux
CHU de Nice-Hôpital Pasteur
NOT_YET_RECRUITING
Nice
Institut Curie - Hôpital de Paris
NOT_YET_RECRUITING
Paris
CHU de Rennes - Hôpital Pontchaillou
NOT_YET_RECRUITING
Rennes
Germany
Charité - Universitätsmedizin Berlin
NOT_YET_RECRUITING
Berlin
Universitätsklinikum Bonn
NOT_YET_RECRUITING
Bonn
Städtisches Klinikum Dessau
NOT_YET_RECRUITING
Dessau
Universitätsklinikum Essen
NOT_YET_RECRUITING
Essen
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
NOT_YET_RECRUITING
Lübeck
Universitätsklinikum Giessen und Marburg - Marburg (UKGM)
NOT_YET_RECRUITING
Marburg
Universitätsklinikum Tübingen
NOT_YET_RECRUITING
Tübingen
Universitätsklinikum Ulm
NOT_YET_RECRUITING
Ulm
Universitätsklinikum Würzburg
NOT_YET_RECRUITING
Würzburg
Greece
PAGNI-University General Hospital of Heraklion
NOT_YET_RECRUITING
Heraklion
Israel
Hadassah Medical Center - PPDS
NOT_YET_RECRUITING
Jerusalem
The Chaim Sheba Medical Center - PPDS
NOT_YET_RECRUITING
Ramat Gan
Italy
Azienda Ospedaliera Universitaria Careggi
NOT_YET_RECRUITING
Florence
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
NOT_YET_RECRUITING
Milan
Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
NOT_YET_RECRUITING
Napoli
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
NOT_YET_RECRUITING
Perugia
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
NOT_YET_RECRUITING
Pisa
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
NOT_YET_RECRUITING
Rome
Netherlands
Erasmus MC
NOT_YET_RECRUITING
Rotterdam
Poland
Uniwersyteckie Centrum Kliniczne w Gdansku - Debinki 7
NOT_YET_RECRUITING
Gdansk
Uniwersytecki Szpital Kliniczny w Poznaniu- Dluga 1/2
NOT_YET_RECRUITING
Poznan
WIM-PIB, Centralny Szpital Kliniczny MON
NOT_YET_RECRUITING
Warsaw
Spain
Hospital Universitario de Bellvitge
NOT_YET_RECRUITING
L'hospitalet De Llobregat
Clinica Universidad Navarra
NOT_YET_RECRUITING
Pamplona
Hospital Clinico Universitario de Santiago
NOT_YET_RECRUITING
Santiago De Compostela
Hospital Universitario Virgen Macarena
NOT_YET_RECRUITING
Seville
Hospital Universitari i Politecnic La Fe de Valencia
NOT_YET_RECRUITING
Valencia
Hospital Clinico Universitario de Valladolid
NOT_YET_RECRUITING
Valladolid
Switzerland
Universitätsspital Basel
NOT_YET_RECRUITING
Basel
Universitätsspital Zürich
NOT_YET_RECRUITING
Zurich
United Kingdom
University College Hospital
NOT_YET_RECRUITING
London
Clatterbridge Cancer Centre - Liverpool - NWCRN - PPDS
NOT_YET_RECRUITING
Metropolitan Borough Of Wirral
Contact Information
Primary
IDEAYA Clinical Trials
IDEAYAClinicalTrials@ideayabio.com
+1-855-433-2246
Backup
Mwe Mwe Chao, MD
mchao@ideayabio.com
Time Frame
Start Date: 2025-10
Estimated Completion Date: 2031-03
Participants
Target number of participants: 520
Treatments
Experimental: Treatment Arm
Darovasetib followed by definitive primary local therapy (i.e., PB, proton beam radiation, or enucleation)
Active_comparator: Control Arm
Immediate Primary Local therapy
Related Therapeutic Areas
Sponsors
Leads: IDEAYA Biosciences