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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07015190




Registration number
NCT07015190
Ethics application status
Date submitted
3/06/2025
Date registered
11/06/2025
Date last updated
15/09/2025

Titles & IDs
Public title
Neoadjuvant Darovasertib in Primary Uveal Melanoma
Scientific title
A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)
Secondary ID [1] 0 0
IDE196-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uveal Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Darovasertib
Treatment: Surgery - Primary Local Therapy

Experimental: Treatment Arm - Darovasetib followed by definitive primary local therapy (i.e., PB, proton beam radiation, or enucleation)

Active comparator: Control Arm - Immediate Primary Local therapy


Treatment: Drugs: Darovasertib
Dosed orally, twice daily (28-day/ cycle

Treatment: Surgery: Primary Local Therapy
Plaque Brachytherapy or Enucleation
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm
Timepoint [1] 0 0
Approximately 3 years
Primary outcome [2] 0 0
Cohort 2: To demonstrate the ability to salvage the eye and prevent enucleation in the Treatment Arm
Timepoint [2] 0 0
Approximately 2 years

Eligibility
Key inclusion criteria
* Primary non-metastatic uveal melanoma
* Able and willing to provide written, informed consent before initiation of any study-related procedures, and in the opinion of the Investigator, to comply with all study requirements
* ECOG 0 or 1
* Adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous treatment for UM
* Evidence of metastatic UM
* Attributes that necessitate enucleation regardless of response to therapy
* Evidence of progressive secondary underlying ocular disease that would confound longitudinal VA assessments
* Presence of a malignant disease other than the one being treated in this study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2031
Actual
Sample size
Target
520
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
5011 - Woodville South
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
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United States of America
State/province [3] 0 0
Massachusetts
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United States of America
State/province [4] 0 0
Michigan
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United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
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Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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Austria
State/province [12] 0 0
Graz
Country [13] 0 0
Austria
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Innsbruck
Country [14] 0 0
Austria
State/province [14] 0 0
Vienna
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Belgium
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Brussels
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Belgium
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Leuven
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
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Czechia
State/province [18] 0 0
Prague
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Denmark
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Capital
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Denmark
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Central Jutland
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France
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Alpes-Maritimes
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France
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Gironde
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France
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Ille-et-Vilaine
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France
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Paris
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Germany
State/province [25] 0 0
Baden-Wurttemberg
Country [26] 0 0
Germany
State/province [26] 0 0
North Rhine-Westphalia
Country [27] 0 0
Germany
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Berlin
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Germany
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Bonn
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Germany
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Lübeck
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Germany
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Marburg
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Greece
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Irakleio
Country [32] 0 0
Israel
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Central District
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Israel
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Jerusalem
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Italy
State/province [34] 0 0
Campania
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Italy
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Milan
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Italy
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Perugia
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Italy
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Tuscany
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Italy
State/province [38] 0 0
Pisa
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Italy
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Rome
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Netherlands
State/province [40] 0 0
South Holland
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Poland
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Greater Poland Voivodeship
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Spain
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A Coruña
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Spain
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Barcelona
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Spain
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Valencia
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Spain
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Valladolid
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Spain
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Seville
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Switzerland
State/province [47] 0 0
Basel
Country [48] 0 0
Switzerland
State/province [48] 0 0
Zurich
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Merseyside
Country [50] 0 0
United Kingdom
State/province [50] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
IDEAYA Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
IDEAYA Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
1 650-534-3616
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07015190