Neoadjuvant Darovasertib in Primary Uveal Melanoma
Sponsor: IDEAYA Biosciences
ClinicalTrials ID:NCT07015190
This Phase 3 study evaluates neoadjuvant darovasertib in primary uveal melanoma patients requiring plaque brachytherapy or enucleation. Participants are randomized into two cohorts, receiving darovasertib before local therapy or immediate local therapy. Eligibility includes non-metastatic status, ECOG 0-1, and adequate organ function. Darovasertib is administered orally, twice daily.
Patient Parameters
| Parameter | Options |
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Program Overview
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
Description
The study is divided into 2 cohorts of patients with primary uveal melanoma requiring either plaque brachytherapy or enucleation.
In cohort 1, patients in the treatment arm will receive neoadjuvant darovasertib followed by plaque brachytherapy compared to immediate plaque brachytherapy (control arm).
In cohort 2, the treatment arm will receive neoadjuvant darovasertib followed by definitive primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation). Subjects in the control arm will go onto immediate enucleation.
Subjects will then receive primary local therapy following neoadjuvant darovasertib.
All patients will be followed for up to 3 years to assess longer term outcomes such as vision and tumor recurrence.
Eligibility Criteria
Inclusion Criteria
- Primary non-metastatic uveal melanoma
- Able and willing to provide written, informed consent before initiation of any study-related procedures, and in the opinion of the Investigator, to comply with all study requirements
- ECOG 0 or 1
- Adequate organ function
Exclusion Criteria
- Previous treatment for UM
- Evidence of metastatic UM
- Attributes that necessitate enucleation regardless of response to therapy
- Evidence of progressive secondary underlying ocular disease that would confound longitudinal VA assessments
- Presence of a malignant disease other than the one being treated in this study
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Scottsdale - PPDS | 85259 | Scottsdale | Arizona |
| UCSD Moores Cancer Center | 92093 | La Jolla | California |
| University of California Irvine Medical Center | 92868 | Orange | California |
| Stanford Comprehensive Cancer Center | 94304 | Palo Alto | California |
| Kaiser Permanente-Riverside Medical Center | 92505-3043 | Riverside | California |
| University of Colorado Hospital | 80045 | Aurora | Colorado |
| The Melanoma and Skin Cancer Institute | 80113-2791 | Englewood | Colorado |
| Mayo Clinic Jacksonville | 32224 | Jacksonville | Florida |
| Wilmer Eye Institute | 21287-0005 | Baltimore | Maryland |
| Massachusetts Eye and Ear Infirmary | 02114 | Boston | Massachusetts |
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