Recruiting
Phase 3

Darovasertib

Sponsor:

IDEAYA Biosciences

Code:

NCT07804186

Conditions

Uveal Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Darovasertib

Crizotinib (Xalkori)

Study Details

Brief summary:

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

Conditions

Uveal Melanoma

Study ID

NCT07804186

Start date

Sep, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2034

Anticipated

Primary completion date

Mar, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Primary Uveal Melanoma, classified as high-risk of relapse (AJCC Stage II or Stage 3)
  • Completed primary local therapy (enucleation, proton beam therapy, plaque brachytherapy)
  • ECOG performance status of 0 or 1
  • Adequate organ function
  • Age 18 or older
  • Written informed consent and ability to comply
  • Primary local therapy completed within 120 days before C1D1/randomization.
  • Contraception requirements

Exclusion Criteria:

  • Previous systemic treatment for Uveal Melanoma
  • Clinical or radiological evidence of metastatic UM
  • Concurrent malignant disease with the following exceptions: malignancies that were treated curatively and have not recurred within 2 years prior to randomization, completely resected basal cell and squamous cell skin cancers, any malignancy considered to be indolent and never required systemic therapy, and any type of carcinoma in situ receiving curative therapy (resection)
  • Known AIDS related illness
  • History of interstitial lung disease, active pneumonitis, or history of noninfectious pneumonitis requiring steroids
  • History of syncope may be exclusionary, but will be reviewed on a case-by-case basis
  • Active Hepatitis B or C infection
  • Any gastrointestinal condition (eg, inflammatory bowel disease, major gastric or intestinal surgery) that could affect absorption or ability to swallow
  • Females who are pregnant or breastfeeding
  • Impaired cardiac function
  • History of stroke within the last 6 months of randomization
  • Ongoing use of medication use for infections, other antineoplastic therapies, or other prohibited medications, including medications that interact with the metabolism of darovasertib+crizotinib
  • allergy to mammalian meat products or gelatin

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

Darovasertib

Oral, selectively targets key proteins

Crizotinib (Xalkori)

Oral small molecule

Primary outcome measure

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

Central Contacts and Locations

Central contacts

IDEAYA Clinical Trials

+1-855-433-2246IDEAYAClinicalTrials@ideayabio.com

Holger Thurm

hthurm@ideayabio.com

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

More Information

Sponsor

IDEAYA Biosciences

Last update posted

Sep 4, 2026

Last verified

Aug, 2026

Keywords

  • Uveal Melanoma
  • plaque brachytherapy
  • enucleation
  • proton beam
  • Adjuvant
  • Darovasertib
  • IDE 196
  • Ocular Melanoma
  • Choroidal Melanoma
  • Ocular Oncology
  • Protein Kinase C
  • GNAQ
  • GNA11
  • Crizotinib

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by IDEAYA Biosciences on 2026-09-04.