(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

Running, not enrolling · Phase 2

Conditions studied: Uveal Melanoma

In brief

Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma

Key facts

Study ID

NCT05907954

Run by

IDEAYA Biosciences

People needed

160

Starts

2023-07-03

Expected to finish

2030-04-30

Last updated by the study team

2026-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy
• Cohort 3 (patients with small UM tumors) - clinically diagnosed uveal (not iris) melanoma that is < 4 mm in thickness requiring treatment
• Able to dose orally
• ECOG Performance status of 0-1
• No other significant underlying ocular disease
• Adequate organ function
• Not pregnant/nursing or planning to become pregnant. Willing to use birth control

You may not qualify if…

• Previous treatment with a Protein Kinase C (PKC) inhibitor
• Concurrent malignant disease
• Active HIV infection or Hep B/C
• Malabsorption disorder
• Unable to discontinue prohibited medication
• Impaired cardiac function or clinically significant cardiac disease
• Any other condition which may interfere with study interpretation or results

Where it is running

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy
• HonorHealth Research Institute — Scottsdale, Arizona, United States
• Moores Cancer Center — La Jolla, California, United States
• Stanford Cancer Institute — Palo Alto, California, United States
• University of Miami — Miami, Florida, United States
• The Cancer and Hematology Centers — Grand Rapids, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Northwell — Manhasset, New York, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• St. Vincent's Health Sydney — Sydney, New South Wales, Australia
• Alfred Health — Melbourne, Victoria, Australia
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• Institute Curie — Paris, France
• Charité - Universitätsmedizin Berlin — Berlin, Germany
• Fondazione IRCCS Istituto Nazionale Tumori — Milan, Italy
• Leiden University Medical Center — Leiden, Netherlands

Full record on ClinicalTrials.gov

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