NCT05907954

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: IDEAYA Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma

Detailed description

Phase 2 multi-center open-label IDE196 study in patients with primary uveal melanoma (UM) requiring either enucleation or plaque brachytherapy. Patients will be treated in neoadjuvant setting up to 12 months (or maximum benefit) followed by primary local therapy. An additional 6 months of adjuvant treatment may be given to some patients. All patients will have long term follow-up (up to 3 years) to assess visual outcome, disease recurrence, and development of metastatic disease.

Conditions

• Uveal Melanoma

Interventions

Type	Name	Description
DRUG	Darovasertib	Oral, potent, selective inhibitor of Protein Kinase C

Timeline

• Start date: 2023-07-03
• Primary completion: 2027-04-30
• Completion: 2030-04-30
• First posted: 2023-06-18
• Last updated: 2026-03-16

Locations

18 sites across 7 countries: United States, Australia, Canada, France, Germany, Italy, Netherlands

Regulatory

• FDA-regulated drug study