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

Launched by IDEAYA BIOSCIENCES · Jun 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called IDE196 (darovasertib) for patients with localized uveal melanoma, a type of eye cancer. The goal is to see how effective this treatment is when given before or after surgery, either enucleation (removal of the eye) or plaque brachytherapy (a type of radiation treatment). The trial is currently looking for participants aged 65 to 74 who can take the medication by mouth and have no other serious eye diseases or significant health issues.

To be eligible, participants should be diagnosed with primary localized uveal melanoma and be in good overall health, as measured by a performance status scale. They should not be pregnant or nursing and must agree to use birth control during the study. Participants will receive the study medication and will be monitored closely throughout the trial. This is an important opportunity for patients who are looking for new treatment options for this condition.

Gender

ALL

Eligibility 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