Uveal MelanomaPhase 3NCT07804186
Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
A Phase 3 study testing Darovasertib and Crizotinib (Xalkori) in people with Uveal Melanoma, run by IDEAYA Biosciences at 13 sites in 2 countries.
Trial summary
This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- Darovasertib and Crizotinib (Xalkori)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Sep 2026to Apr 2034
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Holger Thurm contact
13 sites in 2 countries
United States11 sites, 11 recruiting
- Not yet recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Rizwan Haq, 617-632-5055, rizwan_haq@dfci.harvard.edu
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Lucy Kennedy, 1-216-317-5561, kennedl5@ccf.org
- Not yet recruiting
Cancer Hematology Centers Western Michigan
Grand Rapids, Michigan, 49503
Sreenivasa Chandana, 616-594-9800, schandana@thechc.com
- Not yet recruiting
UCLA Medical Center
Los Angeles, California, 90024
Bartosz Chmielowski, 1-310-825-7768, bchmielowski@mednet.ucla.edu
- Not yet recruiting
University of Wisconsin Health
Madison, Wisconsin, 53792
Vincent Ma, 1-608-915-0100, vtma@medicine.wisc.edu
- Recruiting
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, 37203
Meredith McKean, 1-615-329-7274, meredith.mckean@scri.com
- Not yet recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Alex Shoushtari, 1-212-639-2000, shoushta@mskcc.org
- Not yet recruiting
Northwell Health
New York, New York, 10075
Shaheer Khan, 212-434-2000, skhan137@northwell.edu
- Recruiting
Wills Eye Hospital at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Rino Seedor, 1-215-847-7409, rino.seedor@jefferson.edu
- Not yet recruiting
Duke Cancer Center
Raleigh, North Carolina, 27710
April Salama, 888-275-3853, april.salama@duke.edu
- Recruiting
Honor Health Research Institute
Scottsdale, Arizona, 85258
Justin Moser, 1-480-583-7219, jmoser@honorhealth.com
Canada2 sites, 2 recruiting
- Not yet recruiting
Universite de Montreal - Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
Montréal, Ontario, H2X0C1
Rahima Jamal, 1-514-890-8444, rahima.jamal.med@ssss.gouv.qc.ca
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Marcus Butler, MD
About this study
Official title: A Randomized, Phase 3, Open-label Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)
Read the detailed description
This study will enroll participants who are at high-risk for metastatic disease and who have completed primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation) for their UM without evidence of active local or metastatic disease after this treatment.
The Treatment Arm will have participants who have completed PLT and will receive darovasertib + crizotinib.
The Observation Arm participants will not receive darovasertib + crizotinib but will be observed and followed for disease recurrence and survival (Control Arm)
Participants in both arms will be followed for up to five years to assess longer term outcomes such as tumor recurrence and survival.
- Conditions
- Uveal Melanoma
- Being tested
- Darovasertib, Crizotinib (Xalkori)
- Keywords
- Uveal Melanoma, plaque brachytherapy, enucleation, proton beam, Adjuvant, Darovasertib, IDE 196, Ocular Melanoma, Choroidal Melanoma, Ocular Oncology, Protein Kinase C, GNAQ, GNA11, Crizotinib
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarovasertibDrug
Oral, selectively targets key proteins
Crizotinib (Xalkori)Drug
Oral small molecule
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participant Group/Arm: Treatment combination dose of IDE196 + crizotinib will be tested Receives: Drug: Darovasertib; Drug: Crizotinib (Xalkori) |
| Observation | No intervention | Participant Group/Arm: Observation Standard of care observation \& follow-up (no treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median relapse-free survival
Time to local recurrence or metastatic disease per Blinded Independent Central Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Measured: Approximately 5 years
Secondary outcomes (11)
Median metastasis-free survival
Median MFS, defined as the time from randomization to the date of metastatic disease (outside of the eye or orbit) by BICR per RECIST v 1.1
Measured: Approximately 5 years
Overall survival
Overall survival with darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease who are at high-risk for recurrence
Measured: Approximately 5 years
Median UM specific survival
Median UM specific survival defined as the time from randomization to the date of death due to UM
Measured: Approximately 5 years
Median metastasis-free survival
Median MFS, defined as the time from randomization to the date of metastatic disease (outside of the eye or orbit) as assessed by investigator
Measured: Approximately 5 years
Safety, and severity of occurrence of adverse events (AEs) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) V6.0 or later
To assess safety and tolerability of darovasertib + crizotinib in participants who have completed PLT for primary UM
Measured: Approximately 3 years
Change from baseline over time and across Treatment Arms as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30)
Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM
Measured: Approximately 5 years
Recurrence-free suvival
Compare RFS of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence
Measured: Approximately 5 years
Metastasis-Free Survival
Compare MFS of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence
Measured: Approximately 5 years
Median Local Recurrence-Free Survival
Compare local RFS (LRFS) of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence
Measured: Approximately 5 years
Change from baseline over time and across Treatment Arms as measured by European Quality of Life Questionnaire EQ-5D-5L.
Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM
Measured: [Time Frame: Approximately 5 years]
Change from baseline over time and across Treatment Arms as measured by EORTC Oncology Quality of Life Questionnaire Ophthalmic-30 (EORTC QLQ-OPT30)
Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM
Measured: [Time Frame: Approximately 5 years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2034 (estimated)
- Study completionApr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IDEAYA Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804186
- Sponsor's protocol ID
- IDE196-011
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No