Home › Trials › NCT05907954

Treatment for localized ocular melanoma using darovasertib

(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

PHASE2 · IDEAYA Biosciences · NCT05907954

This study is testing if a new treatment called darovasertib can help people with localized eye melanoma before and after their main treatment to improve their vision and reduce the chance of the cancer coming back.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment82 (estimated)
Ages18 Years and up
SexAll
SponsorIDEAYA Biosciences (industry)
Locations25 sites (Scottsdale, Arizona and 24 other locations)
Trial IDNCT05907954 on ClinicalTrials.gov

What this trial studies

This Phase 2 multi-center open-label study evaluates the effectiveness of darovasertib in patients with primary uveal melanoma who require either enucleation or plaque brachytherapy. Participants will receive neoadjuvant treatment for up to 6 months, followed by primary local therapy, and an additional 6 months of adjuvant treatment. The study aims to assess visual outcomes, disease recurrence, and the development of metastatic disease over a long-term follow-up period of up to 3 years.

Who should consider this trial

Good fit: Ideal candidates are patients with primary localized uveal melanoma who require enucleation or plaque brachytherapy and meet specific health criteria.

Not a fit: Patients with previous treatment using a Protein Kinase C inhibitor or those with concurrent malignant diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with localized ocular melanoma and potentially reduce the risk of disease recurrence.

How similar studies have performed: While there have been studies on uveal melanoma treatments, the specific use of darovasertib in this context is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy
* Able to dose orally
* ECOG Performance status of 0-1
* No other significant underlying ocular disease
* Adequate organ function
* Not pregnant/nursing or planning to become pregnant. Willing to use birth control

Exclusion Criteria:

* Previous treatment with a Protein Kinase C (PKC) inhibitor
* Concurrent malignant disease
* Active HIV infection or Hep B/C
* Malabsorption disorder
* Unable to discontinue prohibited medication
* Impaired cardiac function or clinically significant cardiac disease
* Any other condition which may interfere with study interpretation or results

Where this trial is running

Scottsdale, Arizona and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Uveal Melanoma, Plaque brachytherapy, Enucleation, Neoadjuvant, Adjuvant, Protein Kinase C, Ophthalmology, Ocular Oncology

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.