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ACTIVE NOT RECRUITING
NCT05987332
PHASE2/PHASE3

IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma

Sponsor: IDEAYA Biosciences

View on ClinicalTrials.gov

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

Interventions

DRUG

IDE196

Dosed orally, twice daily

DRUG

Crizotinib

Dosed orally, twice daily

DRUG

Pembrolizumab

IV administration every 3 weeks

DRUG

Ipilimumab

IV administration every 3 weeks for 4 Cycles

DRUG

Nivolumab

IV administration every 3 Weeks for 4 Cycles, thereafter every 4 Weeks maintenance

DRUG

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