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

a study on Ocular Melanoma Skin Cancer/Melanoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
study ends around

Description

Summary

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

Details

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.

Keywords

Uveal Melanoma, Plaque brachytherapy, Enucleation, Neoadjuvant, Adjuvant, Protein Kinase C, Ophthalmology, Ocular Oncology, Darovasertib, IDE196, Ocular melanoma, Choroid melanoma, Plaque, Brachytherapy, Amyloid Plaque

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

  • UCLA Medical Center accepting new patients
    Los Angeles California 90024 United States
  • Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Stanford Cancer Institute accepting new patients
    Palo Alto California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
IDEAYA Biosciences
ID
NCT05907954
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 160 study participants
Last Updated
Contact us about this trial