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Neoadjuvant Darovasertib in Primary Uveal Melanoma

RECRUITINGPhase 3Sponsored by IDEAYA Biosciences
Actively Recruiting
PhasePhase 3
SponsorIDEAYA Biosciences
Started2026-01-25
Est. completion2030-10
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations35 sites
View on ClinicalTrials.gov →

NCT07015190

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerUveal Melanoma

Interventions1

Darovasertib

Locations35 sites

Mayo Clinic Scottsdale - PPDS
Scottsdale, Arizona, 85259
Odette Houghton, MD Principal Investigator
UCSD Moores Cancer Center
La Jolla, California, 92093
Gregory Daniels, MD Principal Investigator
Jules Stein Eye Institute
Los Angeles, California, 90024
Tara McCannel, MD Principal Investigator
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Gino In, MD, Principal Investigator
University of California Irvine Medical Center
Orange, California, 92868
Poorva Vaidya, MD Principal Investigator

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