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Neoadjuvant Darovasertib in Primary Uveal Melanoma

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 87 → 94 locationsv6
  2. Minor Study sites: 75 to 87 Start date changed from estimate of Oct 2025 to Jan 25, 2026v5 Show 1 more changeShow less
    • Start date changed from estimate of Oct 2025 to Jan 25, 2026
  3. Minor Study sites: 60 to 75v4
  4. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date: May 7, 2027 to Oct 2030 · Study sites: 0 to 60 · Completion date: Dec 7, 2027 to Mar 2031 · 1 morev3 Show 4 more changesShow less
    • Primary completion date: May 7, 2027 to Oct 2030
    • Study sites: 0 to 60
    • Completion date: Dec 7, 2027 to Mar 2031
    • Start date: Sep 30, 2025 to Oct 2025
  5. Minor Re-verified, no change to tracked fieldsv2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
1,026 trials monitored
See 48 trials at risk
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
Trial Details
NCT Number NCT07015190
Lead Sponsor IDEAYA Biosciences
Conditions Uveal Melanoma
Enrollment 520 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov