IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma
Condition(s) studied
Investigational drug(s) / intervention(s)
IDE196: Dosed orally, twice daily
Crizotinib: Dosed orally, twice daily
Pembrolizumab: IV administration every 3 weeks
Ipilimumab: IV administration every 3 weeks for 4 Cycles
Nivolumab: IV administration every 3 Weeks for 4 Cycles, thereafter every 4 Weeks maintenance
Dacarbazine: IV administration every 3 Weeks
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).
Eligibility
Primary outcome measure(s)
- Phase 2a: To determine the optimal dose of IDE196 + Crizotinib combination for Phase 2B and Phase 3 by evaluating the following: — Approximately 5 months
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. - Phase 2 Progression-Free Survival (PFS) — Approximately 2 years
by blinded independent central review (BICR) of IDE196 + Crizotinib compared to investigator's choice of treatment per RECIST v1.1 - Phase 3 Overall Survival (OS) of IDE196 + Crizotinib compared to investigator's choice of treatment. — Approximately 4 years
OS from randomization to date of death due to any cause
Trial sites (68)
| Facility | City | Region | Status |
|---|---|---|---|
| Honor Health | Scottsdale | Arizona | |
| Moores Cancer Center | La Jolla | California | |
| UCLA Medical Center | Los Angeles | California | |
| The Angeles Clinic and Research Institute | Los Angeles | California | |
| California Pacific Medical Center (CPMC) | San Francisco | California | |
| University of California San Francisco | San Francisco | California | |
| University of Colorado Cancer Center | Aurora | Colorado | |
| SCRI at HealthONE | Denver | Colorado | |
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | |
| Moffitt Cancer Center | Tampa | Florida | |
| Northside Hospital Atlanta | Atlanta | Georgia | |
| University of Iowa | Iowa City | Iowa | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| The Cancer and Hematology Centers | Grand Rapids | Michigan | |
| Minnesota Oncology Hematology, P.A. | Burnsville | Minnesota | |
| Mayo Clinic | Rochester | Minnesota | |
| Washington University School of Medicine | St Louis | Missouri | |
| Roswell Park Cancer Institute | Buffalo | New York | |
| Northwell Health | Manhasset | New York | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| Duke University Health System | Durham | North Carolina | |
| University of Cincinnati | Cincinnati | Ohio | |
| The Cleveland Clinic Foundation | Cleveland | Ohio | |
| Thomas Jefferson University | Philadelphia | Pennsylvania | |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | |
| SCRI Oncology Partners | Nashville | Tennessee | |
| Texas Oncology- DFW | Dallas | Texas | |
| UT Southwestern Medical Center | Dallas | Texas | |
| Houston Methodist Cancer Center | Houston | Texas | |
| MD Anderson Cancer Center | Houston | Texas | |
| Westmead Hospital | Sydney | New South Wales | |
| Princess Alexander Hospital | Brisbane | Queensland | |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | |
| Alfred Health | Melbourne | Victoria | |
| Sir Charles Gairdner Hospital | Perth | Washington | |
| Queen Elizabeth Hospital | Adelaide | Australia | |
| Cliniques Universitaires Saint Luc | Brussels | Belgium | |
| Algemene Medische Oncologie UZ | Leuven | Belgium | |
| Cross Cancer Institute, University of Alberta | Edmonton | Alberta |
+ 28 more sites — see the full list on the official registry below.
More IDEAYA Biosciences trials in Spain
Other trials for the same condition
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 NCT05987332 on ClinicalTrials.gov ↗ ← All trials in Spain