Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
IDEAYA Biosciences
Study ID
NCT07804186
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Darovasertib — DRUG
    Oral, selectively targets key proteins
  • Crizotinib (Xalkori) — DRUG
    Oral small molecule

Study Details

This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)

Key Dates

First listed
Sep 4, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Mar 31, 2034
Completion
Apr 30, 2034

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Participant Group/Arm: Treatment combination dose of IDE196 + crizotinib will be tested
  • No Intervention: Observation
    Participant Group/Arm: Observation Standard of care observation \& follow-up (no treatment)

Primary Outcome Measure

Median relapse-free survival [ Time Frame: Approximately 5 years ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Honor Health Research InstituteScottsdaleArizona85258
Justin Moser
[email protected]
1-480-583-7219
UCLA Medical CenterLos AngelesCalifornia90024
Bartosz Chmielowski
[email protected]
1-310-825-7768
Dana Farber Cancer InstituteBostonMassachusetts02215
Rizwan Haq
[email protected]
617-632-5055
Cancer Hematology Centers Western MichiganGrand RapidsMichigan49503
Sreenivasa Chandana
[email protected]
616-594-9800
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Alex Shoushtari
[email protected]
1-212-639-2000
Northwell HealthNew YorkNew York10075
Shaheer Khan
[email protected]
212-434-2000
Duke Cancer CenterRaleighNorth Carolina27710
April Salama
[email protected]
888-275-3853
Cleveland ClinicClevelandOhio44195
Lucy Kennedy
[email protected]
1-216-317-5561
Wills Eye Hospital at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Rino Seedor
[email protected]
1-215-847-7409
Sarah Cannon Research Institute (SCRI)NashvilleTennessee37203
Meredith McKean
[email protected]
1-615-329-7274
University of Wisconsin HealthMadisonWisconsin53792
Vincent Ma
[email protected]
1-608-915-0100

Find similar trials in Scottsdale, AZ

By research site
Honor Health Research Institute· Scottsdale, AZUCLA Medical Center· Los Angeles, CADana Farber Cancer Institute· Boston, MACancer Hematology Centers Western Michigan· Grand Rapids, MIMemorial Sloan Kettering Cancer Center· New York, NYNorthwell Health· New York, NY

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