A Phase 2/3 Study of IDE196 (Darovasertib) and Crizotinib Compared to Standard Treatment in Uveal Melanoma


Full Title

IDE196 (Darovasertib) In Combination With Crizotinib Versus Investigator’s Choice Of Treatment As First-Line Therapy In HLA-A2 Negative Metastatic Uveal Melanoma


Researchers want to compare IDE196 (darovasertib) and crizotinib with standard treatments in people with uveal (eye) melanoma. The people in this study have uveal melanoma that has metastasized (spread). The standard treatments are types of immunotherapy.

IDE196 blocks a protein called PKC, which uveal melanoma depends on for growth. Crizotinib blocks a protein called MET which may be found in high amounts on uveal melanoma cells. If you join this study, you will be randomly assigned to receive either IDE196/crizotinib or standard immunotherapy.

If you are in part 1 of the study and receive IDE196/crizotinib, you will get either a higher dose or lower dose of IDE196. The best dose of IDE196 identified in part 1 will be used in part 2 of the study. IDE196 and crizotinib are taken orally, and the other medications are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have metastatic uveal melanoma and have not yet received treatment for advanced disease.
  • Have recovered from the serious side effects of prior therapies before getting the study treatment.
  • Be negative for the HLA-A*02:01 protein.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.


For more information and to see if you can join this study, please call Dr. Alexander Shoushtari’s office at 646-888-4161.




Phase II/III (phases 2 and 3 combined)

Disease Status

Newly Diagnosed


ClinicalTrials.gov ID