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 Italy
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 Italy