Darovasertib and crizotinib after treatment for early uveal melanoma
Tests darovasertib with crizotinib in adults with uveal melanoma that has not spread.
Plain-language title generated from the registry record
Registry title: Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
Key facts
- Where
- Montréal and Toronto, CanadaSee the 2 sites
- Phase
- Phase 3
Where in Canada
- Universite de Montreal - Centre de Recherche du Centre Hospitalier de l'Universite de MontrealMontréal, CanadaNot yet recruiting
- Princess Margaret Cancer CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IDEAYA Biosciences
- Trial code
- NCT07804186
- Record updated
- 15 September 2026
- Original description
This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)Read full original descriptionShow less
A Randomized, Phase 3, Open-label Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
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; Primary local therapy completed within 120 days before C1D1/randomization; Contraception requirements.
Exclusion: Previous systemic treatment for Uveal Melanoma; 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; Active Hepatitis B or C infection; Any gastrointestinal condition (eg, inflammatory bowel disease, major gastric or intestinal surgery) that could affect absorption or ability to swallow; Impaired cardiac function; History of stroke within the last 6 months of randomization; Ongoing use of medication use for infections, other antineoplastic therapies, or other prohibited medications, including medications that interact with the metabolism of darovasertib+crizotinib; allergy to mammalian meat products or gelatin; Clinical or radiological evidence of metastatic UM; Females who are pregnant or breastfeeding.