Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
Start Date
9/1/2026
Completion Date
4/1/2034
Summary
This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)
Detailed Description
This study will enroll participants who are at high-risk for metastatic disease and who have completed primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation) for their UM without evidence of active local or metastatic disease after this treatment. The Treatment Arm will have participants who have completed PLT and will receive darovasertib + crizotinib. The Observation Arm participants will not receive darovasertib + crizotinib but will be observed and followed for disease recurrence and survival (Control Arm) Participants in both arms will be followed for up to five years to assess longer term outcomes such as tumor recurrence and survival.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Darovasertib
Crizotinib (Xalkori)
Conditions
Locations
Honor Health Research Institute
Scottsdale, Arizona 85258
United States
UCLA Medical Center
Los Angeles, California 90024
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Cancer Hematology Centers Western Michigan
Grand Rapids, Michigan 49503
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Northwell Health
New York, New York 10075
United States
Duke Cancer Center
Raleigh, North Carolina 27710
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Wills Eye Hospital at Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee 37203
United States
University of Wisconsin Health
Madison, Wisconsin 53792
United States
Universite de Montreal - Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
Montréal, Ontario H2X0C1
Canada
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
Canada