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

March 26, 2024 updated by: IDEAYA Biosciences
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
    • Victoria
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
  • France
      • Paris, France
        • Not yet recruiting
        • Institute Curie
  • Germany
      • Berlin, Germany, D-10117
        • Not yet recruiting
        • Charite Comprehensive Cancer Center
      • Essen, Germany, 45147
        • Not yet recruiting
        • University Hospital Essen - West German Cancer Center
  • Italy
      • Milano, Italy, 20133
        • Not yet recruiting
        • Instituto Nazionale Tumori di Milano
      • Naples, Italy, 80131
        • Not yet recruiting
        • Instituto Nazionale Tumori IRCCS - Fondazione Pascale
      • Rome, Italy, 00168
        • Not yet recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
        • Not yet recruiting
        • Leiden University Medical Center
  • United Kingdom
      • Liverpool, United Kingdom, L7 8YA
        • Not yet recruiting
        • The Clatterbridge Cancer Centre NHS FT
      • London, United Kingdom, NW1 2PG
        • Not yet recruiting
        • University College London Hospital - NHS Foundation Trust
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
    • California
      • Los Angeles, California, United States, 90024
    • Colorado
    • Florida
      • Miami, Florida, United States, 33146
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • The Cancer and Hematology Centers
        • Contact:
        • Contact:
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Not yet recruiting
        • Wills Eye Hospital/Thomas Jefferson University
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute
        • Contact:
          • Ask Sarah
          • Phone Number: 844-482-4812
    • Texas

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: darovasertib
IDE196 (darovasertib) oral open label
Drug: Darovasertib
Oral, potent, selective inhibitor of Protein Kinase C
Other Names:
  • IDE196
  • LXS196

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AEs) and significant laboratory abnormalities
Time Frame: from first dose to last dose of adjuvant therapy, approximately 12 months
Treatment emergent adverse events will be summarized by all AEs, all Grade 3-4-5 AEs, all treatment related AEs, all AEs leading to study drug modifications or discontinuations, all SAEs. Lab results will be summarized by change from baseline values, frequency of newly occurring on-treatment Grade 3 or 4 events; worst on-treatment value compared to baseline.
from first dose to last dose of adjuvant therapy, approximately 12 months
Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation
Time Frame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Rate of eye salvage as determined by the ocular oncologist based on tumor response to neoadjuvant therapy
from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose
Time Frame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Change in modeled radiation dose at critical eye structures before and after neoadjuvant therapy
from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate tumor response to neoadjuvant IDE196
Time Frame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Measurement of tumor diameter and thickness before and after neoadjuvant therapy with IDE196, specifically as measured by ocular ultrasound, evaluating largest basal diameter and apical thickness of the uveal melanoma (measured in millimeters)
from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Assessment of visual acuity loss
Time Frame: from time of primary local therapy to one year after surgery, approximately 12 months
Best corrected visual acuity loss over time
from time of primary local therapy to one year after surgery, approximately 12 months
Rate of local disease recurrence
Time Frame: from date of primary local therapy to end of follow-up, approximately 36 months
Evaluate uveal melanoma progression or recurrence
from date of primary local therapy to end of follow-up, approximately 36 months
Rate of metastatic disease
Time Frame: from date of primary local therapy to end of follow-up, approximately 36 months
Evaluate occurrence of metastatic uveal melanoma
from date of primary local therapy to end of follow-up, approximately 36 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: from date of first dose to end of follow-up, approximately 44 months
Evaluate patient survival status
from date of first dose to end of follow-up, approximately 44 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IDEAYA Biosciences

Investigators

  • Study Director: Jasgit Sachdev, MD, 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 Major Dates

Study Start (Actual)

July 3, 2023

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 14, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDE196-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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