RECRUITING

Neoadjuvant Darovasertib in Primary Uveal Melanoma

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Conditions

Uveal MelanomaPlaque BrachytherapyEnucleationNeoadjuvantDarovasertibIDE 196Ocular MelanomaChoroidal MelanomaOphthalmologyOcular OncologyMelanomaProtein Kinase CGNAQGNA11

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)

Quick Facts

Study Start:2025-10
Study Completion:2031-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07015190

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Primary non-metastatic uveal melanoma
  2. * 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
  3. * ECOG 0 or 1
  4. * Adequate organ function
  1. * Previous treatment for UM
  2. * Evidence of metastatic UM
  3. * Attributes that necessitate enucleation regardless of response to therapy
  4. * Evidence of progressive secondary underlying ocular disease that would confound longitudinal VA assessments
  5. * Presence of a malignant disease other than the one being treated in this study

Contacts and Locations

Study Contact

IDEAYA Clinical Trials
CONTACT
1 650-534-3616
IDEAYAClinicalTrials@ideayabio.com
Mwe Mwe Chao, MD
CONTACT
mchao@ideayabio.com

Study Locations (Sites)

UCSD Moores Cancer Center
La Jolla, California, 92093
United States
University of California Irvine Medical Center
Orange, California, 92868
United States
Stanford Comprehensive Cancer Center
Palo Alto, California, 94304
United States
Wilmer Eye Institute
Baltimore, Maryland, 21287-0005
United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
United States
W Kellogg Eye Center
Ann Arbor, Michigan, 48105
United States
The Cancer and Hematology Centers of West Michigan (CHCWM)
Grand Rapids, Michigan, 49503
United States
Mayo Clinic - PPDS
Rochester, Minnesota, 55905
United States
Memorial Sloan Kettering Cancer Center - 1275 York Ave
New York, New York, 10065-6635
United States
Cole Eye Institute-9500 Euclid Ave
Cleveland, Ohio, 44195
United States
Ohio State Eye and Ear Institute
Columbus, Ohio, 43212
United States
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, 19107
United States
Southeastern Retina Associates-Hixson
Hixson, Tennessee, 37343
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
Austin Retina Associates - Central
Austin, Texas, 78705
United States
Texas Retina Associates - Dallas
Dallas, Texas, 75231
United States
University of Texas Southwestern Medical Center-5323 Harry Hines Blvd
Dallas, Texas, 75390-9057
United States
RetinaCare of Virginia Charlottesville
Charlottesville, Virginia, 22901
United States

Collaborators and Investigators

Sponsor: IDEAYA Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-10
Study Completion Date2031-03

Study Record Updates

Study Start Date2025-10
Study Completion Date2031-03

Terms related to this study

Keywords Provided by Researchers

  • Uveal Melanoma
  • Plaque Brachytherapy
  • Enucleation
  • Neoadjuvant
  • Darovasertib
  • IDE 196
  • Ocular Melanoma
  • Choroidal Melanoma
  • Ophthalmology
  • Ocular Oncology
  • Melanoma
  • Protein Kinase C
  • GNAQ
  • GNA11

Additional Relevant MeSH Terms

  • Uveal Melanoma