A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects with PrimaryNon-metastatic Uveal Melanoma (OptimUM-10)

The study drug used in this study is darovasertib. The study drug will be given to you orally (by mouth) if you participate in the study. You should only take the study drug as instructed. Darovasertib is an investigational (experimental) new drug, which means darovasertib has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authorities in the world. Darovasertib blocks a protein in your body called Protein Kinase C (PKC). Approximately 90% of people with uveal melanoma have a genetic mutation in PKC. The tumor may depend on the effects of PKC to survive and grow. By blocking PKC with darovasertib, it is hoped that tumor growth and tumor size may be reduced. You are being asked to participate in this study because you have primary uveal melanoma with no evidence of distant or metastatic disease. The purpose of this study is to test whether your tumor shrinks in size while taking the study drug (a so-called tumor response) and to further assess safety and tolerability or how well your body responds to the study drug. The Sponsor also wants to find out what effects, good and/or bad, the study drug has on participants with uveal melanoma.

Are you Eligible? (Inclusion Criteria)

• Be at least 18 years old - Not pregnant/breastfeeding or planning on becoming pregnant/breastfeeding during the duration of the study trial - Able to safely swallow pill medications - Not allergic to meat products and gelatin