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

Last updated: October 24, 2024
Sponsor: IDEAYA Biosciences
Overall Status: Active - Recruiting

Phase

2

Condition

Melanoma

Treatment

Darovasertib

Clinical Study ID

NCT05907954
IDE196-009
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Primary localized uveal melanoma requiring either enucleation or plaquebrachytherapy

  • 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

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

Study Design

Total Participants: 82
Treatment Group(s): 1
Primary Treatment: Darovasertib
Phase: 2
Study Start date:
July 03, 2023
Estimated Completion Date:
January 31, 2029

Study 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.

Connect with a study center

  • St Vincent's Public Hospital Sydney

    Sydney, New South Wales 2010
    Australia

    Site Not Available

  • St. Vincent's Health Sydney

    Sydney, New South Wales 2010
    Australia

    Active - Recruiting

  • Alfred Health

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Alfred Univ. Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Princess Margaret Cancer Center

    Toronto, Ontario M5G2M9
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G2M9
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre- University Health Network

    Toronto, Ontario M5G2M9
    Canada

    Active - Recruiting

  • Institute Curie

    Paris, 75005
    France

    Active - Recruiting

  • Charite Comprehensive Cancer Center

    Berlin, D-10117
    Germany

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin, 12203
    Germany

    Active - Recruiting

  • University Hospital Essen - West German Cancer Center

    Essen, 45147
    Germany

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale Tumori

    Milan, 20133
    Italy

    Active - Recruiting

  • Instituto Nazionale Tumori di Milano

    Milano, 20133
    Italy

    Site Not Available

  • Instituto Nazionale Tumori IRCCS - Fondazione Pascale

    Naples, 80131
    Italy

    Site Not Available

  • Instituto Nazionale Tumori IRCCS - Fondazione Pascale

    Napoli, 80131
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168
    Italy

    Active - Recruiting

  • Leiden University Medical Center

    Leiden, 2333 ZA
    Netherlands

    Active - Recruiting

  • The Clatterbridge Cancer Centre NHS FT

    Liverpool, L7 8YA
    United Kingdom

    Site Not Available

  • University College London Hospital - NHS Foundation Trust

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Wirral, CH63 4JY
    United Kingdom

    Active - Recruiting

  • HonorHealth Research Institute

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • Moores Cancer Center

    La Jolla, California 92093
    United States

    Active - Recruiting

  • UCLA

    Los Angeles, California 90024
    United States

    Site Not Available

  • UCLA Medical Center

    Los Angeles, California 90024
    United States

    Active - Recruiting

  • Stanford Cancer Institute

    Palo Alto, California 94305
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • University of Miami

    Miami, Florida 33146
    United States

    Active - Recruiting

  • The Cancer and Hematology Centers

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Northwell

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • Northwell

    New York, New York 11030
    United States

    Site Not Available

  • Duke University Health System

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Wills Eye Hospital/Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • UT Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

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