(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
NCT ID: NCT05907954
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
160 participants
INTERVENTIONAL
2023-07-03
2030-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma
NCT05987332
Neoadjuvant Darovasertib in Primary Uveal Melanoma
NCT07015190
Neoadjuvant/Adjuvant Trial of Darovasertib in Ocular Melanoma
NCT05187884
A Phase II Study of BVD-523 in Metastatic Uveal Melanoma
NCT03417739
Study of the Activity of PD-1 Inhibitors in Metastatic Uveal Melanoma
NCT03964298
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
darovasertib
IDE196 (darovasertib) oral open label
Darovasertib
Oral, potent, selective inhibitor of Protein Kinase C
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Darovasertib
Oral, potent, selective inhibitor of Protein Kinase C
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IDEAYA Biosciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jasgit Sachdev, MD
Role: STUDY_DIRECTOR
IDEAYA Biosciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
HonorHealth Research Institute
Scottsdale, Arizona, United States
Moores Cancer Center
La Jolla, California, United States
UCLA Medical Center
Los Angeles, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Sarah Cannon Research Institute
Denver, Colorado, 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
Duke University Health System
Durham, North Carolina, 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
Instituto Nazionale Tumori IRCCS - Fondazione Pascale
Napoli, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, , Italy
Leiden University Medical Center
Leiden, , Netherlands
University College London Hospital - NHS Foundation Trust
London, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: primary
Ask Sarah
Role: primary
Role: primary
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IDE196-009
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.