Status:
RECRUITING
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Lead Sponsor:
IDEAYA Biosciences
Conditions:
Uveal Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy
- Cohort 3 (patients with small UM tumors) - clinically diagnosed uveal (not iris) melanoma that is \< 4 mm in thickness requiring treatment
- 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
- 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
Key Trial Info
Start Date :
July 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2030
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05907954
Start Date
July 3 2023
End Date
April 30 2030
Last Update
October 22 2025
Active Locations (24)
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1
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
2
Moores Cancer Center
La Jolla, California, United States, 92093
3
UCLA Medical Center
Los Angeles, California, United States, 90024
4
Stanford Cancer Institute
Palo Alto, California, United States, 94305