NCT07804186 · IDEAYA Biosciences
Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
What this study is about
This is a randomly assigned, multi-center, where both patients and doctors know the treatment given study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)
View original scientific description
This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)
Interventions
DRUG
Darovasertib
Oral, selectively targets key proteins
DRUG
Crizotinib (Xalkori)
Oral small molecule
Primary outcome measures
Median relapse-free survival
Time frame: Approximately 5 years
Time to local recurrence or metastatic disease per Blinded Independent Central Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Scottsdale, Arizona
- Los Angeles, California
- Boston, Massachusetts
- Grand Rapids, Michigan
- New York, New York
- Raleigh, North Carolina
- Cleveland, Ohio
- Philadelphia, Pennsylvania
- Nashville, Tennessee
- Madison, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 15, 2026 · Source of record for eligibility and locations