Active — Not RecruitingPhase 2

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

United States, Australia, Canada160 participantsStarted 2023-07-03

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Adverse Events (AEs) and significant laboratory abnormalities

Timeframe: from first dose to 28 days after last dose of therapy, approximately 18 months

Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation

Timeframe: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months

Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose

Timeframe: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months

Cohort 3 (patients with small UM tumors): Number of patients with clinical benefit per protocol-defined UM response criteria

Timeframe: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months

Trial details

NCT IDNCT05907954

SponsorIDEAYA Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-30

View on ClinicalTrials.gov More Uveal Melanoma trials