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(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

NCT05907954•IDEAYA Biosciences

View on ClinicalTrials.gov

Summary

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

Detailed Description

Phase 2 multi-center open-label IDE196 study in patients with primary uveal melanoma (UM) requiring either enucleation or plaque brachytherapy. Patients will be treated in neoadjuvant setting up to 12 months (or maximum benefit) followed by primary local therapy. An additional 6 months of adjuvant treatment may be given to some patients. All patients will have long term follow-up (up to 3 years) to assess visual outcome, disease recurrence, and development of metastatic disease.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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

Locations (18)

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

Key Dates

Start Date

July 3, 2023

Primary Completion Date

April 30, 2027

Completion Date

April 30, 2030

Last Updated

March 16, 2026

Enrollment

160

ESTIMATED participants

Conditions

Uveal Melanoma

Interventions

Darovasertib

DRUG

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

NCT06007690

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RECRUITINGPHASE2/PHASE3

A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma

A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma

Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma

Adding IL-2 to Tebentafusp to Eradicate Cancer Progression

Adjuvant Melatonin for Uveal Melanoma