Treatment for localized ocular melanoma using darovasertib

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• HonorHealth Research Institute
  Scottsdale, Arizona, United States Recruiting
• Moores Cancer Center
  La Jolla, California, United States Recruiting
• UCLA Medical Center
  Los Angeles, California, United States Recruiting
• Stanford Cancer Institute
  Palo Alto, California, United States Recruiting
• Sarah Cannon Research Institute
  Denver, Colorado, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: IDEAYA Clinical Trials
• Email: IDEAYAClinicalTrials@ideayabio.com
• Phone: 1 650-534-3616

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Darovasertib before local treatment for primary uveal melanoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.