IDE196 in Combination with Crizotinib in Metastatic Uveal Melanoma

What is the Purpose of this Study?

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.


Eligibility

  • * Histological or cytological confirmed Metastatic Uveal Melanoma
  • * HLA-A\*02:01 negative
  • * No prior systemic therapy in the metastatic or advanced setting or regional or liver-directed therapy. Ablations or surgical resection of oligometastatic disease, and neoadjuvant or adjuvant therapy is allowed
  • * Measurable disease per RECIST 1.1
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Where can I participate?

CS Cancer at The Angeles Clinic and Research Institute

More about this Clinical Trial

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

Study Details
Disease Type/Condition

Eye and Orbit, Melanoma

Principal Investigator

Mehmi, Inderjit

Co-Investigators

Cathie T Chung, Kristopher Wentzel, Mark Faries, Navid Hafez, Omid Hamid, Vi K. Chiu

Age Group

Adult

Phase

II/III

IRB Number

STUDY00003074

ClinicalTrials.gov ID

NCT05987332

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Eye and Orbit, Melanoma

Principal Investigator

Mehmi, Inderjit

Age Group

Adult

Phase

II/III

IRB Number

IDE196-002

ClinicalTrials.gov ID

NCT05987332

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org