Active — Not RecruitingPhase 2

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

United States160 participantsStarted 2023-07-03

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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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

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