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Taking people in United StatesPhase 3

Darovasertib and crizotinib after treatment for early uveal melanoma

Tests darovasertib with crizotinib in adults with uveal melanoma that has not spread.

Key facts

Who runs it
IDEAYA Biosciences
Where
Boston, Cleveland, Dallas, Grand Rapids, Houston, Los Angeles, Madison, Miami, Nashville, New York, Philadelphia, Raleigh, San Diego, San Francisco, Scottsdale, and Tampa, United StatesSee the 20 sitesAlso in 5 other countries, 9 sites
Trial code
Registry title
Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
Status
Recruiting
Phase
Phase 3
People taking part
450 people, planned
Started
4 Sept 2026
Expected to end
Apr 2034
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Darovasertib
  • Crizotinib (Xalkori)
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with uveal melanoma (an eye cancer) that has not spread and is at high risk of coming back, who have finished local treatment of the eye tumour.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Primary uveal melanoma at high risk of relapse (AJCC Stage II or Stage 3), with no sign of spread to other parts of the body.
Earlier treatment
Must have finished local treatment (enucleation, proton beam therapy or plaque brachytherapy) within 120 days before randomization. Must not have had earlier systemic treatment for uveal melanoma.

Main reasons for not taking part

  • Earlier systemic treatment for uveal melanoma
  • Signs of metastatic uveal melanoma on exam or scans
  • Another active cancer, with some exceptions
  • Interstitial lung disease or pneumonitis needing steroids
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Previous systemic treatment for Uveal Melanoma
  • 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
  • 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
  • Clinical or radiological evidence of metastatic UM
  • Females who are pregnant or breastfeeding

Where in United States

Also in 5 other countries, 9 sites

  • Dana-Farber Cancer InstituteBoston, United StatesContact: Rizwan HaqNot yet recruiting
  • Cleveland ClinicCleveland, United StatesContact: Lucy KennedyTaking people
  • The University of Texas Southwestern Medical CenterDallas, United StatesContact: Sanjay ChandrasekaranNot yet recruiting
  • Cancer Hematology Centers Western MichiganGrand Rapids, United StatesContact: Sreenivasa ChandanaNot yet recruiting
  • UT MD Anderson Cancer CenterHouston, United StatesContact: Mohamed GoudaNot yet recruiting
  • Angeles ClinicLos Angeles, United StatesContact: Inderjit MehmiNot yet recruiting
  • UCLA Medical CenterLos Angeles, United StatesContact: Bartosz ChmielowskiNot yet recruiting
  • University of Wisconsin HealthMadison, United StatesContact: Vincent MaNot yet recruiting
  • University of MiamiMiami, United StatesContact: Jose LutzkyNot yet recruiting
  • Sarah Cannon Research Institute SCRINashville, United StatesContact: Meredith McKeanTaking people
  • Columbia University / Herbert Irving Comprehensive Cancer CenterNew York, United StatesContact: Benjamin IzarNot yet recruiting
  • Memorial Sloan-Kettering Cancer CenterNew York, United StatesContact: Alex ShoushtariNot yet recruiting
  • Northwell HealthNew York, United StatesContact: Shaheer KhanNot yet recruiting
  • Wills Eye Hospital at Thomas Jefferson UniversityPhiladelphia, United StatesContact: Rino SeedorTaking people
  • Duke Cancer CenterRaleigh, United StatesContact: April SalamaTaking people
  • University of California San DiegoSan Diego, United StatesContact: Gregory DanielsNot yet recruiting
  • Sutter Health CPMCSan Francisco, United StatesContact: Kevin KimNot yet recruiting
  • University of California San FranciscoSan Francisco, United StatesContact: Katy TsaiNot yet recruiting
  • Honor Health Research InstituteScottsdale, United StatesContact: Justin MoserTaking people
  • USF Health Eye InstituteTampa, United StatesContact: Jorge AgiNot yet recruiting

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • TreatmentTreatment being tested

    Participant Group/Arm: Treatment combination dose of IDE196 + crizotinib will be tested

    Treatment: Darovasertib and Crizotinib (Xalkori)

  • ObservationNo study treatment, for comparison

    Participant Group/Arm: Observation Standard of care observation \& follow-up (no treatment)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomized, Phase 3, Open-label Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
Plain-language title
Darovasertib and crizotinib after treatment for early uveal melanomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
12 November 2026