RECRUITING

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

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Conditions

Uveal MelanomaPlaque brachytherapyEnucleationNeoadjuvantAdjuvantProtein Kinase COphthalmologyOcular OncologyDarovasertibIDE196Ocular melanomaChoroid melanomaPlaqueBrachytherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-07-03
Study Completion:2029-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05907954

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy
  2. * Able to dose orally
  3. * ECOG Performance status of 0-1
  4. * No other significant underlying ocular disease
  5. * Adequate organ function
  6. * Not pregnant/nursing or planning to become pregnant. Willing to use birth control
  1. * Previous treatment with a Protein Kinase C (PKC) inhibitor
  2. * Concurrent malignant disease
  3. * Active HIV infection or Hep B/C
  4. * Malabsorption disorder
  5. * Unable to discontinue prohibited medication
  6. * Impaired cardiac function or clinically significant cardiac disease
  7. * Any other condition which may interfere with study interpretation or results

Contacts and Locations

Study Contact

IDEAYA Clinical Trials
CONTACT
1 650-534-3616
IDEAYAClinicalTrials@ideayabio.com
Jasgit Sachdev, MD
CONTACT
jsachdev@ideayabio.com

Principal Investigator

Jasgit Sachdev, MD
STUDY_DIRECTOR
IDEAYA Biosciences

Study Locations (Sites)

HonorHealth Research Institute
Scottsdale, Arizona, 85258
United States
Moores Cancer Center
La Jolla, California, 92093
United States
UCLA Medical Center
Los Angeles, California, 90024
United States
Stanford Cancer Institute
Palo Alto, California, 94305
United States
Sarah Cannon Research Institute
Denver, Colorado, 80218
United States
University of Miami
Miami, Florida, 33146
United States
The Cancer and Hematology Centers
Grand Rapids, Michigan, 49546
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Northwell
Manhasset, New York, 11030
United States
Duke University Health System
Durham, North Carolina, 27710
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: IDEAYA Biosciences

  • Jasgit Sachdev, MD, STUDY_DIRECTOR, IDEAYA Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-03
Study Completion Date2029-01-31

Study Record Updates

Study Start Date2023-07-03
Study Completion Date2029-01-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Uveal Melanoma