Clinical Trials in the USA / NCT07804186
Recruiting
Phase 3
Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
NCT07804186 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Uveal Melanoma
Investigational drug(s) / intervention(s)
Darovasertib: Oral, selectively targets key proteins
Crizotinib (Xalkori): Oral small molecule
Study summary
This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)
Eligibility
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
Primary outcome measure(s)
- Median relapse-free survival — 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)
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| Honor Health Research Institute | Scottsdale | Arizona | Recruiting |
| UCLA Medical Center | Los Angeles | California | Not Yet Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Not Yet Recruiting |
| Cancer Hematology Centers Western Michigan | Grand Rapids | Michigan | Not Yet Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Not Yet Recruiting |
| Northwell Health | New York | New York | Not Yet Recruiting |
| Duke Cancer Center | Raleigh | North Carolina | Not Yet Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Not Yet Recruiting |
| Wills Eye Hospital at Thomas Jefferson University | Philadelphia | Pennsylvania | Recruiting |
| Sarah Cannon Research Institute (SCRI) | Nashville | Tennessee | Recruiting |
| University of Wisconsin Health | Madison | Wisconsin | Not Yet Recruiting |
| Universite de Montreal - Centre de Recherche du Centre Hospitalier de l'Universite de Montreal | Montréal | Ontario | Not Yet Recruiting |
| Princess Margaret Cancer Centre | Toronto | Ontario | Recruiting |
More IDEAYA Biosciences trials in the USA
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Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
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Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
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Other trials for the same condition
A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors
Active, not recruiting
Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma
Active, not recruiting
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07804186 on ClinicalTrials.gov ↗ ← All trials in the USA