Neoadjuvant Darovasertib in Primary Uveal Melanoma
Recruiting · NCT07015190 · Interventional (participants receive a specific treatment) · Lead sponsor: IDEAYA Biosciences
View the official record on ClinicalTrials.gov →Interventions studied
DarovasertibPrimary Local Therapy
What this trial is about
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
60 locations listed across 17 US states.
- 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
- USC Norris Comprehensive Cancer Center - 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
- UCSF Wayne and Gladys Valley Center for Vision - San Francisco, 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
- Moffit Cancer Center - 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
- Retina Consultants of Oklahoma - Oklahoma City, Oklahoma, United States
- Jefferson Health Honickman Center - Philadelphia, Pennsylvania, United States
- UPMC Hillman Cancer Center - Pittsburgh, Pennsylvania, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- Vanderbilt Eye Institute - 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
- Fakultna nemocnica s poliklinikou F. D. Roosevelta - Banská Bystrica, Slovakia
- Universitätsspital Basel - Basel, Switzerland
- Charité - Universitätsmedizin Berlin - Berlin, Germany
- Universitätsklinikum Bonn - Bonn, Germany
- Cliniques Universitaires Saint-Luc - PPDS - Brussels, Belgium
- LKH-Universitätsklinikum Graz - Graz, Austria
- Universitätsklinikum Innsbruck - Innsbruck, Austria
- UZ Leuven - PPDS - Leuven, Belgium
- University College Hospital - London, United Kingdom
- Universitätsklinikum Schleswig-Holstein - Campus Lübeck - Lübeck, Germany
- Universitätsklinikum Giessen und Marburg - Marburg (UKGM) - Marburg, Germany
- Centre Hospitalier National D'ophtalmologie Des Quinze Vingts - Paris, France
- Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia - Pisa, Italy
- Fondazione Policlinico Universitario A Gemelli - Rome - PPDS - Rome, Italy
- Hospital Universitario Virgen Macarena - Seville, Spain
- Weston Park Cancer Centre - PPDS - Sheffield, United Kingdom
- Universitätsklinikum AKH Wien - Vienna, Austria
- The Crown Princess Mary Cancer Centre (Westmead Hospital), NSW 214 - Westmead, Australia
- Universitätsklinikum Würzburg - Würzburg, Germany
- Universitätsspital Zürich - Zurich, Switzerland
- Hospital Clinico Universitario de Santiago - Santiago de Compostela, A Coruña, Spain
- Cross Cancer Institute - Edmonton, Alberta, Canada
- CHU de Nice-Hôpital Pasteur - Nice, Alpes-Maritimes, France
- Auckland Eye - Auckland, Auckland, New Zealand
- Universitätsklinikum Tübingen - Tübingen, Baden-Wurttemberg, Germany
Showing 60 of 94 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →