Clinical trial · Interventional
Neoadjuvant Darovasertib in Primary Uveal Melanoma
A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)
NCT07015190CI-TRIAL-00110640recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Darovasertib | Drug | — | UNRESOLVED |
| Primary Local Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- Darovasetib followed by definitive primary local therapy (i.e., PB, proton beam radiation, or enucleation)
- interventionNames
- Drug: Darovasertib
- type
- ACTIVE_COMPARATOR
- label
- Control Arm
- description
- Immediate Primary Local therapy
- interventionNames
- Procedure: Primary Local Therapy
Primary outcomes (2)
- measure
- Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.