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NCT05987332 · ClinicalTrials.gov registry record · Phase 2
IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma
A Phase 2 study of Metastatic Uveal Melanoma, sponsored by IDEAYA Biosciences.
- Active
- Registry status
- Phase 2
- Development phase
- 420
- Enrollment target
- 20
- Study locations
NCT05987332: Active Phase 2 study of Metastatic Uveal Melanoma, sponsored by IDEAYA Biosciences.
NCT05987332 is a Phase 2 study of Metastatic Uveal Melanoma that is active but no longer recruiting, run by IDEAYA Biosciences. The registered enrollment target is 420 participants, above the 103-participant average among 14 other Metastatic Uveal Melanoma trials with a reported enrollment target (308% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05987332, a Phase 2 study of Metastatic Uveal Melanoma, is active but no longer recruiting, sponsored by IDEAYA Biosciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 420 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen (HLA)-A\*02:01 negative participants with metastatic uveal melanoma (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).
Primary Outcome
dose exposure response (safety and efficacy) relationship, plasma concentration profiles and pharmacokinetic (PK) parameters, treatment-emergent Adverse Events (TEAEs), laboratory abnormalities, electrocardiogram (ECG), and vital sign changes and study treatment discontinuation due to AEs.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG IDE196
- DRUG Crizotinib
Study Locations (20)
California
- Moores Cancer Center - La Jolla
- UCLA Medical Center - Los Angeles
- The Angeles Clinic and Research Institute - Los Angeles
- California Pacific Medical Center (CPMC) - San Francisco
- University of California San Francisco - San Francisco
Colorado
- University of Colorado Cancer Center - Aurora
- SCRI at HealthONE - Denver
Florida
- University of Miami Sylvester Comprehensive Cancer Center - Miami
- Moffitt Cancer Center - Tampa
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
Minnesota
- Minnesota Oncology Hematology, P.A. - Burnsville
- Mayo Clinic - Rochester
New York
- Roswell Park Cancer Institute - Buffalo
- Northwell Health - Manhasset
Arizona
- Honor Health - Scottsdale
Georgia
- Northside Hospital Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2023-10-31 |
| Est. Completion | 2028-01-15 |
| Phase | Phase 2 |
What the registry record for NCT05987332 still lists
NCT05987332 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, above the 103-participant average among 14 other Metastatic Uveal Melanoma trials with a reported enrollment target (308% higher).
The record links to 1 condition, with Metastatic Uveal Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT05987332 names 20 study sites across 11 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT05987332 about?
NCT05987332 is a clinical study titled "IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma". This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen (HLA)-A\*02:01 negative participants with metastatic uveal melanoma (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab...
What is the current status of trial NCT05987332?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 420 participants. The study started on 2023-10-31. Estimated completion is 2028-01-15.
What conditions does trial NCT05987332 study?
This clinical trial studies the following conditions: Metastatic Uveal Melanoma.
What interventions are being tested in trial NCT05987332?
The interventions under investigation include: Pembrolizumab (DRUG), Nivolumab (DRUG), Ipilimumab (DRUG), IDE196 (DRUG), Crizotinib (DRUG).
Who is sponsoring clinical trial NCT05987332?
This trial is sponsored by IDEAYA Biosciences, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05987332 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05987332's enrollment target sits among peer trials
420 1st of 14 higher than 14 of 14 other Metastatic Uveal Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Uveal Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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