The purpose of this study is to determine whether an experimental medication, IDE196 (also called darovasertib), in combination with another drug, crizotinib, is safe and effective in people who have cancer in their eye (uveal melanoma/ocular melanoma/choroidal melanoma) which has spread (metastasized) to another part of the body (metastatic uveal melanoma). IDE196 blocks a protein in the body called protein kinase C (PKC). The tumor may depend on the effects of PKC to survive and grow. By blocking PKC with IDE196, it is hoped that tumor growth and size may be reduced. Crizotinib is approved by the U.S. Food and Drug Administration (FDA) for other conditions, but its use in this study is experimental. Participants will be randomly assigned to receive either the study treatment or standard-of-care treatment (the usual treatment given for metastatic uveal melanoma). Researchers aim to determine the effectiveness of the combination of IDE196 and crizotinib compared to standard-of-care therapy.
What is the full name of this clinical trial?
IDE196-002: IDE196 in Combination with Crizotinib Versus Investigator s Choice of Treatment as First-line Therapy in HLA-A2 Negative Metastatic Uveal Melanoma