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โ† Trials
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Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma

RecruitingPhase 3Ages 18 Years - anyAllIDEAYA Biosciences
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Darovasertib
  • Crizotinib (Xalkori)
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Where

13 sites
Honor Health Research Institute
Scottsdale, United States
UCLA Medical Center
Los Angeles, United States
Dana Farber Cancer Institute
Boston, United States
Cancer Hematology Centers Western Michigan
Grand Rapids, United States
Memorial Sloan Kettering Cancer Center
New York, United States
Northwell Health
New York, United States
Duke Cancer Center
Raleigh, United States
Cleveland Clinic
Cleveland, United States

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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