Back to results(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Primary Purpose
Uveal Melanoma
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Darovasertib
Sponsored by
About this trial
This is an interventional treatment trial for Uveal Melanoma focused on measuring Uveal Melanoma, Plaque brachytherapy, Enucleation, Neoadjuvant, Adjuvant, Protein Kinase C, Ophthalmology, Ocular Oncology, Darovasertib, IDE196, Ocular melanoma, Choroid melanoma, Plaque, Brachytherapy
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
Sites / Locations
- UCLA
- Sarah Cannon Research InstituteRecruiting
- University of MiamiRecruiting
- The Cancer and Hematology CentersRecruiting
- Northwell
- Duke University Medical Center
- Wills Eye Hospital/Thomas Jefferson University
- Sarah Cannon Research InstituteRecruiting
- UT Southwestern
- St Vincent's Public Hospital Sydney
- Alfred Univ. Hospital
- Princess Margaret Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
darovasertib
Arm Description
IDE196 (darovasertib) oral open label
Outcomes
Primary Outcome Measures
Incidence of Adverse Events (AEs) and significant laboratory abnormalities
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.
Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation
Rate of eye salvage as determined by the ocular oncologist based on tumor response to neoadjuvant therapy
Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose
Change in modeled radiation dose at critical eye structures before and after neoadjuvant therapy
Secondary Outcome Measures
Evaluate tumor response to neoadjuvant IDE196
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)
Assessment of visual acuity loss
Best corrected visual acuity loss over time
Rate of local disease recurrence
Evaluate uveal melanoma progression or recurrence
Rate of metastatic disease
Evaluate occurrence of metastatic uveal melanoma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05907954
Brief Title
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Official Title
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2023 (Actual)
Primary Completion Date
January 31, 2026 (Anticipated)
Study Completion Date
January 31, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IDEAYA Biosciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveal Melanoma
Keywords
Uveal Melanoma, Plaque brachytherapy, Enucleation, Neoadjuvant, Adjuvant, Protein Kinase C, Ophthalmology, Ocular Oncology, Darovasertib, IDE196, Ocular melanoma, Choroid melanoma, Plaque, Brachytherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
darovasertib
Arm Type
Experimental
Arm Description
IDE196 (darovasertib) oral open label
Intervention Type
Drug
Intervention Name(s)
Darovasertib
Other Intervention Name(s)
IDE196, LXS196
Intervention Description
Oral, potent, selective inhibitor of Protein Kinase C
Primary Outcome Measure Information:
Title
Incidence of Adverse Events (AEs) and significant laboratory abnormalities
Description
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.
Time Frame
from first dose to last dose of adjuvant therapy, approximately 12 months
Title
Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation
Description
Rate of eye salvage as determined by the ocular oncologist based on tumor response to neoadjuvant therapy
Time Frame
from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Title
Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose
Description
Change in modeled radiation dose at critical eye structures before and after neoadjuvant therapy
Time Frame
from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Secondary Outcome Measure Information:
Title
Evaluate tumor response to neoadjuvant IDE196
Description
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)
Time Frame
from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Title
Assessment of visual acuity loss
Description
Best corrected visual acuity loss over time
Time Frame
from time of primary local therapy to one year after surgery, approximately 12 months
Title
Rate of local disease recurrence
Description
Evaluate uveal melanoma progression or recurrence
Time Frame
from date of primary local therapy to end of follow-up, approximately 36 months
Title
Rate of metastatic disease
Description
Evaluate occurrence of metastatic uveal melanoma
Time Frame
from date of primary local therapy to end of follow-up, approximately 36 months
Other Pre-specified Outcome Measures:
Title
Overall survival
Description
Evaluate patient survival status
Time Frame
from date of first dose to end of follow-up, approximately 44 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
IDEAYA Clinical Trials
Phone
1 650-534-3616
Email
IDEAYAClinicalTrials@ideayabio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Maurer, MD
Email
mmaurer@ideayabio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Maurer, MD
Organizational Affiliation
IDEAYA Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sarah Cannon Research Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Cannon
Phone
720-754-2610
Email
cann.ddudenvergeneral@sarahcannon.com
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Group
Email
CRSCutaneous@miami.edu
Facility Name
The Cancer and Hematology Centers
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
The Cancer and Hematology Centers of Western Michigan
Phone
616-954-5550
Email
ClinicalTrials@chcwm.com
First Name & Middle Initial & Last Name & Degree
Jessica Miller, RN
Phone
616-954-5550
Ext
1651
Email
jmiller@chcwm.com
Facility Name
Northwell
City
New York
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Wills Eye Hospital/Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ask Sarah
Phone
844-482-4812
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
St Vincent's Public Hospital Sydney
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Alfred Univ. Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
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