NCT07015190Recruiting
Neoadjuvant Darovasertib in Primary Uveal Melanoma
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)
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Australia, Belgium, Canada, Czechia, Denmark, Estonia, Greece, Israel, Netherlands, New Zealand, Poland, Slovakia, Slovenia, Spain, United Kingdom
- Sponsor
- IDEAYA Biosciences(Industry)
- Protocol no.
- IDE196-010
- Conditions
- Uveal Melanoma
- Interventions
- Drug, Procedure
Treatments studied
- Darovasertib
- Primary Local Therapy
Locations · 25
- Basel, SwitzerlandUniversitätsspital BaselRecruiting at this site
- Zurich, SwitzerlandUniversitätsspital ZürichRecruiting at this site
- Florence, ItalyAzienda Ospedaliera Universitaria CareggiRecruiting at this site
- Scottsdale, United StatesMayo Clinic Scottsdale - PPDSRecruiting at this site
- Palo Alto, United StatesStanford Comprehensive Cancer CenterRecruiting at this site
- Riverside, United StatesKaiser Permanente-Riverside Medical CenterRecruiting at this site
- Aurora, United StatesUniversity of Colorado HospitalRecruiting at this site
- Jacksonville, United StatesMayo Clinic JacksonvilleRecruiting at this site
- Baltimore, United StatesWilmer Eye InstituteRecruiting at this site
- Grand Rapids, United StatesThe Cancer and Hematology Centers of West Michigan (CHCWM)Recruiting at this site
- Rochester, United StatesMayo Clinic - PPDSRecruiting at this site
- New York, United StatesHerbert Irving Comprehensive Cancer CenterRecruiting at this site
- Nashville, United StatesSCRI Oncology PartnersRecruiting at this site
- Austin, United StatesAustin Retina Associates - CentralRecruiting at this site
- Dallas, United StatesTexas Retina Associates - DallasRecruiting at this site
- Dallas, United StatesUniversity of Texas Southwestern Medical Center-5323 Harry Hines BlvdRecruiting at this site
- Brussels, BelgiumCliniques Universitaires Saint-Luc - PPDSRecruiting at this site
- Toronto, CanadaPrincess Margaret Cancer CentreRecruiting at this site
- Prague, CzechiaUstredni vojenska nemocnice - Vojenska fakultni nemocnice PrahaRecruiting at this site
- Ramat Gan, IsraelThe Chaim Sheba Medical Center - PPDSRecruiting at this site
- Jerusalem, IsraelHadassah Medical Center - PPDSRecruiting at this site
- Santiago de Compostela, SpainHospital Clinico Universitario de SantiagoRecruiting at this site
- Pamplona, SpainClinica Universidad NavarraRecruiting at this site
- Valladolid, SpainHospital Clinico Universitario de ValladolidRecruiting at this site
- Seville, SpainHospital Universitario Virgen MacarenaRecruiting at this site
In total, worldwide, 25 of the 94 sites listed in the registry are recruiting; the other 69 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: May 6, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.