Purpose of this Study
This study has three parts called screening, treatment or observation, and follow up. During screening, doctors will do tests and exams to see if a person can join. If they join the study, they will be placed into one of two groups by chance. One group will take two study medicines called darovasertib and crizotinib by mouth for up to about one year. The other group will not take study medicines but will be closely watched by doctors.
Everyone in the study will have regular clinic visits with blood tests, scans, and eye exams. Doctors will continue to follow participants for several years, up to about six years, to see how they are doing and if the cancer comes back.
Who Can Participate?
Eligibility
People can join this study if they are 18 years old or older and have a type of eye cancer called uveal melanoma. Their cancer must have already been treated with surgery or radiation and has not spread to other parts of the body. They must be at high risk for the cancer to come back. They cannot have received other treatments that affect the whole body for this cancer before.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is being done to see if two medicines called darovasertib and crizotinib can help stop a type of eye cancer from coming back. Researchers also want to learn about any side effects from these medicines. They will compare people who take the medicines to people who are only closely watched by their doctors. The goal is to find better ways to treat this eye cancer and help patients stay healthy in the future.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Randomized, Phase 3, Open-Label Study of Adjuvant Darovasertib and Crizotinib in Participants with Primary Non-Metastatic Uveal Melanoma (OptimUM-11)
Principal Investigator
April
Salama
Protocol Number
PRO00120575
NCT ID
NCT07804186
Phase
III
Enrollment Status
Open to Enrollment