Neoadjuvant Darovasertib in Primary Uveal Melanoma

Recruiting now · Phase 3

Conditions studied: Uveal Melanoma

In brief

This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)

Key facts

Study ID

NCT07015190

Run by

IDEAYA Biosciences

People needed

520

Starts

2026-01-25

Expected to finish

2031-03-01

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Hadassah Medical Center - PPDS — Jerusalem, Jerusalem, Israel (enrolling)
• Universitätsspital Basel — Basel, Switzerland (enrolling)
• Texas Retina Associates - Dallas — Dallas, Texas, United States (enrolling)
• The Chaim Sheba Medical Center - PPDS — Ramat Gan, Central District, Israel (enrolling)
• Hospital Clinico Universitario de Valladolid — Valladolid, Valladolid, Spain (enrolling)
• Hospital Universitario Virgen Macarena — Seville, Spain (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Austin Retina Associates - Central — Austin, Texas, United States (enrolling)
• Cliniques Universitaires Saint-Luc - PPDS — Brussels, Belgium (enrolling)
• Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha — Prague, Prague, Czechia (enrolling)
• Hospital Clinico Universitario de Santiago — Santiago de Compostela, A Coruña, Spain (enrolling)
• Clinica Universidad Navarra — Pamplona, Navarre, Spain (enrolling)
• Wilmer Eye Institute — Baltimore, Maryland, United States (enrolling)
• Kaiser Permanente-Riverside Medical Center — Riverside, California, United States (enrolling)
• Mayo Clinic Scottsdale - PPDS — Scottsdale, Arizona, United States (enrolling)
• The Cancer and Hematology Centers of West Michigan (CHCWM) — Grand Rapids, Michigan, United States (enrolling)
• Mayo Clinic - PPDS — Rochester, Minnesota, United States (enrolling)
• University of Colorado Hospital — Aurora, Colorado, United States (enrolling)
• Herbert Irving Comprehensive Cancer Center — New York, New York, United States (enrolling)
• University of Texas Southwestern Medical Center-5323 Harry Hines Blvd — Dallas, Texas, United States (enrolling)
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States (enrolling)
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
• Stanford Comprehensive Cancer Center — Palo Alto, California, United States (enrolling)
• Azienda Ospedaliera Universitaria Careggi — Florence, Tuscany, Italy (enrolling)
• Universitätsspital Zürich — Zurich, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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