Ireland
--:--IST
Recruiting Phase 3

Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma

NCT07804186 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2026-09
Last updated
2026-09-15

Condition(s) studied

Uveal Melanoma

Investigational drug(s) / intervention(s)

Darovasertib →Crizotinib (Xalkori) →

Darovasertib: Oral, selectively targets key proteins

Crizotinib (Xalkori): Oral small molecule

Study summary

This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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 * 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 * Females who are pregnant or breastfeeding * 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

Primary outcome measure(s)

  • Median relapse-free survival — Approximately 5 years
    Time to local recurrence or metastatic disease per Blinded Independent Central Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

Trial sites (13)

FacilityCityRegionStatus
Honor Health Research Institute Scottsdale Arizona Recruiting
UCLA Medical Center Los Angeles California Not Yet Recruiting
Dana Farber Cancer Institute Boston Massachusetts Not Yet Recruiting
Cancer Hematology Centers Western Michigan Grand Rapids Michigan Not Yet Recruiting
Memorial Sloan Kettering Cancer Center New York New York Not Yet Recruiting
Northwell Health New York New York Not Yet Recruiting
Duke Cancer Center Raleigh North Carolina Not Yet Recruiting
Cleveland Clinic Cleveland Ohio Not Yet Recruiting
Wills Eye Hospital at Thomas Jefferson University Philadelphia Pennsylvania Recruiting
Sarah Cannon Research Institute (SCRI) Nashville Tennessee Recruiting
University of Wisconsin Health Madison Wisconsin Not Yet Recruiting
Universite de Montreal - Centre de Recherche du Centre Hospitalier de l'Universite de Montreal Montréal Ontario Not Yet Recruiting
Princess Margaret Cancer Centre Toronto Ontario Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07804186 on ClinicalTrials.gov ↗ ← All trials in Canada