Adjuvant darovasertib and crizotinib in high-risk non-metastatic uveal melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3, randomized, multi-center trial examining adjuvant therapy with darovasertib plus crizotinib versus observation in patients who completed primary local treatment for high-risk uveal melanoma. Participants are adults with non-metastatic disease and good performance status who have had plaque brachytherapy, proton beam therapy, or enucleation and show no active disease. Participants in the treatment arm receive the combination for a defined period, while the control arm is followed to monitor for recurrence and survival over up to five years. The study aims to determine if the adjuvant regimen can reduce tumor recurrence and improve longer-term outcomes compared with observation alone.

Why it matters

Who can join: the full rules

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 it's running

• Honor Health Research Institute
  Scottsdale, Arizona, United States Recruiting
• Wills Eye Hospital at Thomas Jefferson University
  Philadelphia, Pennsylvania, United States Recruiting
• Sarah Cannon Research Institute (SCRI)
  Nashville, Tennessee, United States Recruiting
• Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting
• UCLA Medical Center
  Los Angeles, California, United States Not yet recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Not yet recruiting

Study contacts

• Study coordinator: IDEAYA Clinical Trials
• Email: IDEAYAClinicalTrials@ideayabio.com
• Phone: +1-855-433-2246

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.