Home › Uveal Melanoma › NCT07804186
Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
RecruitingPhase 3
A Randomized, Phase 3, Open-label Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)
What is being tested
- Darovasertib (drug)
- Crizotinib (Xalkori) (drug)
Sponsor: IDEAYA Biosciences · Participants: 450 · Started: 2026-09
Contact the study team
- IDEAYA Clinical Trials · Phone: +1-855-433-2246
Official record on ClinicalTrials.gov — NCT07804186
Locations in the U.S.
| Arizona | Honor Health Research Institute, Scottsdale |
| California | UCLA Medical Center, Los Angeles (Not yet recruiting) |
| Massachusetts | Dana Farber Cancer Institute, Boston (Not yet recruiting) |
| Michigan | Cancer Hematology Centers Western Michigan, Grand Rapids (Not yet recruiting) |
| New York | Memorial Sloan Kettering Cancer Center, New York (Not yet recruiting) Northwell Health, New York (Not yet recruiting) |
| North Carolina | Duke Cancer Center, Raleigh (Not yet recruiting) |
| Ohio | Cleveland Clinic, Cleveland (Not yet recruiting) |
| Pennsylvania | Wills Eye Hospital at Thomas Jefferson University, Philadelphia |
| Tennessee | Sarah Cannon Research Institute (SCRI), Nashville |
| Wisconsin | University of Wisconsin Health, Madison (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.