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Neoadjuvant Darovasertib in Primary Uveal Melanoma

NCT07015190 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2026-05-06

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Darovasertib

Dosed orally, twice daily (28-day/ cycle

PROCEDURE

Primary Local Therapy

Plaque Brachytherapy or Enucleation

Sponsors & Collaborators

  • IDEAYA Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-25
Primary Completion
2030-10-31
Completion
2031-03-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Slovakia
  • Slovenia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07015190 on ClinicalTrials.gov