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IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma
Sponsor: IDEAYA Biosciences
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).
Official title: IDE196 (Darovasertib) in Combination With Crizotinib Versus Investigator's Choice of Treatment as First-line Therapy in HLA-A2 Negative Metastatic Uveal Melanoma (DAR-UM-2)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
420
Start Date
2023-10-31
Completion Date
2028-01-15
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
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
Locations (68)
Honor Health
Scottsdale, Arizona, United States
Moores Cancer Center
La Jolla, California, United States
UCLA Medical Center
Los Angeles, California, United States
The Angeles Clinic and Research Institute
Los Angeles, California, United States
California Pacific Medical Center (CPMC)
San Francisco, California, United States
University of California San Francisco
San Francisco, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
SCRI at HealthONE
Denver, Colorado, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northside Hospital Atlanta
Atlanta, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
The Cancer and Hematology Centers
Grand Rapids, Michigan, United States
Minnesota Oncology Hematology, P.A.
Burnsville, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Northwell Health
Manhasset, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Health System
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Texas Oncology- DFW
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Houston Methodist Cancer Center
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Westmead Hospital
Sydney, New South Wales, Australia
Princess Alexander Hospital
Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Perth, Washington, Australia
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, Canada
BC Cancer Agency
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal- CHUM
Montreal, Quebec, Canada
The Leon Berard Center
Lyon, France
Institut Curie
Paris, France
NCT Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, Germany
Universitätsklinikum Essen (AöR)
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Hadassah Medical Center
Jerusalem, Israel
Sheba Medical Center
Ramat Gan, Israel
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Istituto Nazionale dei Tumori Fondazione Pascale
Naples, Italy
Fondazione Policlinico Gemelli IRCCS
Roma, Italy
AOUS Policlinico Le Scotte
Siena, Italy
LUMC (Leids Universitair Medisch Centrum)
Leiden, Netherlands
Ośrodek Badań Klinicznych Wczesnych Faz, Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy
Warsaw, Poland
Catalan Institute of Oncology
L'Hospitalet de Llobregat, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital General Universitario Valencia
Valencia, Spain
Dermatologische Klinik, USZ Flughafen Geschoss 7 - Klinische Forschung
Zurich, Switzerland
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, United Kingdom
Mount Vernon Cancer Centre East & North Herts NHS Trust
Northwood, United Kingdom