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

Sponsor: IDEAYA Biosciences

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05907954

Patient View

This Phase 2 open-label study evaluates neoadjuvant/adjuvant darovasertib in patients with primary uveal melanoma needing enucleation or plaque brachytherapy. Participants receive up to 6 months of neoadjuvant treatment, followed by local therapy and 6 months of adjuvant treatment. Eligibility includes ECOG 0-1, oral dosing capability, and adequate organ function. Darovasertib is a selective Protein Kinase C inhibitor.

Patient Parameters

Program Overview

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

Description

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

Eligibility Criteria

Inclusion Criteria

  • Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy
  • 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

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