(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Sponsor: IDEAYA Biosciences
ClinicalTrials ID:NCT05907954
This Phase 2 open-label study evaluates neoadjuvant/adjuvant darovasertib in patients with primary uveal melanoma needing enucleation or plaque brachytherapy. Participants receive up to 6 months of neoadjuvant treatment, followed by local therapy and 6 months of adjuvant treatment. Eligibility includes ECOG 0-1, oral dosing capability, and adequate organ function. Darovasertib is a selective Protein Kinase C inhibitor.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
Description
Phase 2 multi-center open-label IDE196 study in patients with primary uveal melanoma requiring either enucleation or plaque brachytherapy. Patients will be treated in neoadjuvant setting up to 6 months (or maximum benefit) followed by primary local therapy. An additional 6 months of adjuvant treatment to follow with long term follow-up (up to 3 years) to assess visual outcome, disease recurrence, and development of metastatic disease.
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| HonorHealth Research Institute | 85258 | Scottsdale | Arizona |
| Moores Cancer Center | 92093 | La Jolla | California |
| UCLA Medical Center | 90024 | Los Angeles | California |
| Stanford Cancer Institute | 94305 | Palo Alto | California |
| Sarah Cannon Research Institute | 80218 | Denver | Colorado |
| University of Miami | 33146 | Miami | Florida |
| The Cancer and Hematology Centers | 49546 | Grand Rapids | Michigan |
| Mayo Clinic Rochester | 55905 | Rochester | Minnesota |
| Northwell | 11030 | Manhasset | New York |
| Duke University Health System | 27710 | Durham | North Carolina |
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