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

• Status: Recruiting
• Trial end date: 2029-01-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IDEAYA Biosciences

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