NCT07804186
Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
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Record History
All 3 versions: 3 with changes below.
- Minor Trial sites expanded: 13 → 29 locations
- Start date changed from estimate of Sep 2026 to Sep 4, 2026
- Minor Trial sites expanded: 1 → 13 locations
- Study First Submitted
- Minor: routine updates
Endpoints
Primary
Median relapse-free survival
Timeframe: Approximately 5 years
Secondary (10)
Median metastasis-free survival
Overall survival
Median UM specific survival
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
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)
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Recurrence-free suvival
Metastasis-Free Survival
Median Local Recurrence-Free Survival
Change from baseline over time and across Treatment Arms as measured by European Quality of Life Questionnaire EQ-5D-5L.
Change from baseline over time and across Treatment Arms as measured by EORTC Oncology Quality of Life Questionnaire Ophthalmic-30 (EORTC QLQ-OPT30)
Arms and interventions
TreatmentExperimental
Participant Group/Arm: Treatment combination dose of IDE196 + crizotinib will be tested
ObservationNo intervention
Participant Group/Arm: Observation Standard of care observation \& follow-up (no treatment)
Drugs: Darovasertib, Crizotinib (Xalkori)
Sites
29 sites in 6 countries
United States 20, Australia 2, Canada 2, Israel 2, United Kingdom 2, Switzerland 1