NCT07804186
Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
Recruiting · Phase 3 · IDEAYA Biosciences · registry updated 2026-09-15
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)
Inclusion
- Primary Uveal Melanoma, classified as high-risk of relapse (AJCC Stage II or Stage 3)
- Completed primary local therapy (enucleation, proton beam therapy, plaque brachytherapy)
- ECOG performance status of 0 or 1
- Adequate organ function
- Age 18 or older
- Written informed consent and ability to comply
Exclusion
- Previous systemic treatment for Uveal Melanoma
- Clinical or radiological evidence of metastatic UM
- Concurrent malignant disease with the following exceptions: malignancies that were treated curatively and have not recurred within 2 years prior to randomization, completely resected basal cell and squamous cell skin cancers, any malignancy considered to be indolent and never required systemic therapy, and any type of carcinoma in situ receiving curative therapy (resection)
- Known AIDS related illness
- History of interstitial lung disease, active pneumonitis, or history of noninfectious pneumonitis requiring steroids
- History of syncope may be exclusionary, but will be reviewed on a case-by-case basis