Not currently recruiting at UC Irvine

Neoadjuvant Darovasertib in Primary Uveal Melanoma

a study on Ocular Melanoma Skin Cancer/Melanoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange 5379513, California 5332921 and other locations
Dates
study started
study ends around

Description

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)

Official Title

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

Details

The study is divided into 2 cohorts of patients with primary uveal melanoma requiring either plaque brachytherapy or enucleation.

In cohort 1, patients in the treatment arm will receive neoadjuvant darovasertib followed by plaque brachytherapy compared to immediate plaque brachytherapy (control arm).

In cohort 2, the treatment arm will receive neoadjuvant darovasertib followed by definitive primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation). Subjects in the control arm will go onto immediate enucleation.

Subjects will then receive primary local therapy following neoadjuvant darovasertib.

All patients will be followed for up to 3 years to assess longer term outcomes such as vision and tumor recurrence.

Keywords

Uveal Melanoma, Plaque Brachytherapy, Enucleation, Neoadjuvant, Darovasertib, IDE 196, Ocular Melanoma, Choroidal Melanoma, Ophthalmology, Ocular Oncology, Melanoma, Protein Kinase C, GNAQ, GNA11, Primary Local Therapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • University of California Irvine Medical Center not yet accepting patients
    Orange 5379513 California 5332921 92868 United States
  • UCSD Moores Cancer Center not yet accepting patients
    La Jolla 5363943 California 5332921 92093 United States
  • Texas Retina Associates - Dallas accepting new patients
    Dallas 4684888 Texas 4736286 75231 United States
  • University of Texas Southwestern Medical Center-5323 Harry Hines Blvd not yet accepting patients
    Dallas 4684888 Texas 4736286 75390-9057 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
IDEAYA Biosciences
ID
NCT07015190
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 520 study participants
Last Updated