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)
Status: Recruiting
Location: See all (67) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histological or cytological confirmed Metastatic Uveal Melanoma
• HLA-A\*02:01 negative
• No prior systemic therapy in the metastatic or advanced setting or regional or liver-directed therapy. Ablations or surgical resection of oligometastatic disease, and neoadjuvant or adjuvant therapy is allowed
• Measurable disease per RECIST 1.1
• Able to be safely administered and absorb study therapy
• ECOG performance status 0 or 1
• Life expectancy of ≥3 months
• Adequate organ function
Locations
United States
Arizona
Honor Health
RECRUITING
Scottsdale
California
Moores Cancer Center
RECRUITING
La Jolla
The Angeles Clinic and Research Institute
RECRUITING
Los Angeles
UCLA Medical Center
RECRUITING
Los Angeles
California Pacific Medical Center (CPMC)
RECRUITING
San Francisco
University of California San Francisco
RECRUITING
San Francisco
Colorado
University of Colorado Cancer Center
RECRUITING
Aurora
SCRI at HealthONE
RECRUITING
Denver
Florida
University of Miami Sylvester Comprehensive Cancer Center
RECRUITING
Miami
Moffitt Cancer Center
RECRUITING
Tampa
Georgia
Northside Hospital Atlanta
RECRUITING
Atlanta
Iowa
University of Iowa
RECRUITING
Iowa City
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Michigan
The Cancer and Hematology Centers
RECRUITING
Grand Rapids
Minnesota
Minnesota Oncology Hematology, P.A.
RECRUITING
Burnsville
Mayo Clinic
RECRUITING
Rochester
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
Duke University Health System
RECRUITING
Durham
New York
Roswell Park Cancer Institute
RECRUITING
Buffalo
Northwell Health
RECRUITING
Manhasset
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
University of Cincinnati
RECRUITING
Cincinnati
The Cleveland Clinic Foundation
RECRUITING
Cleveland
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
Texas Oncology- DFW
RECRUITING
Dallas
UT Southwestern Medical Center
RECRUITING
Dallas
Houston Methodist Cancer Center
RECRUITING
Houston
MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
Australia
Queen Elizabeth Hospital
RECRUITING
Adelaide
Princess Alexander Hospital
RECRUITING
Brisbane
Alfred Health
RECRUITING
Melbourne
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Sir Charles Gairdner Hospital
RECRUITING
Perth
Westmead Hospital
RECRUITING
Sydney
Belgium
Cliniques Universitaires Saint Luc
RECRUITING
Brussels
Canada
Cross Cancer Institute, University of Alberta
RECRUITING
Edmonton
Centre Hospitalier de l'Universite de Montreal- CHUM
RECRUITING
Montreal
Princess Margaret Cancer Centre
RECRUITING
Toronto
BC Cancer Agency
RECRUITING
Vancouver
France
The Leon Berard Center
RECRUITING
Lyon
Institut Curie
RECRUITING
Paris
Germany
Charité - Universitätsmedizin Berlin
RECRUITING
Berlin
Universitätsklinikum Köln
RECRUITING
Cologne
Universitätsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Universitätsklinikum Essen (AöR)
RECRUITING
Essen
NCT Heidelberg
RECRUITING
Heidelberg
Israel
Hadassah Medical Center
RECRUITING
Jerusalem
Sheba Medical Center
RECRUITING
Ramat Gan
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
Istituto Nazionale dei Tumori Fondazione Pascale
RECRUITING
Napoli
Fondazione Policlinico Gemelli IRCCS
RECRUITING
Roma
AOUS Policlinico Le Scotte
RECRUITING
Siena
Netherlands
LUMC (Leids Universitair Medisch Centrum)
RECRUITING
Leiden
Poland
Ośrodek Badań Klinicznych Wczesnych Faz, Uniwersyteckie Centrum Kliniczne w Gdańsku
RECRUITING
Gdansk
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy
RECRUITING
Warsaw
Spain
Catalan Institute of Oncology
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Clínico Universitario de Santiago de Compostela
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital General Universitario Valencia
RECRUITING
Valencia
Switzerland
Dermatologische Klinik, USZ Flughafen Geschoss 7 - Klinische Forschung
RECRUITING
Zurich
United Kingdom
The Beatson West of Scotland Cancer Centre
RECRUITING
Glasgow
The Clatterbridge Cancer Centre NHS Foundation Trust
RECRUITING
Metropolitan Borough Of Wirral
Mount Vernon Cancer Centre East & North Herts NHS Trust
RECRUITING
Northwood
Contact Information
Primary
IDEAYA Clinical Trials
IDEAYAClinicalTrials@ideayabio.com
1 650-534-3616
Backup
Hetal Patel, MD, MSHS, CHCQM
hpatel@ideayabio.com
650-741-3856
Time Frame
Start Date: 2023-10-31
Estimated Completion Date: 2028-01-15
Participants
Target number of participants: 420
Treatments
Experimental: Phase 2a Dose Optimization of IDE196 + crizotinib
Multiple doses of IDE196 will be tested in combination with fixed dose of crizotinib to identify the optimal combination dose.
Experimental: Phase 2b / 3 Chosen Combination dose of IDE196 + crizotinib
Chosen combination dose of IDE196 + crizotinib will be tested in additional participants.
Active_comparator: Phase 2a / 2b / 3 Comparator Arm
Participants will receive investigator's choice of Pembrolizumab, Ipilimumab + Nivolumab, or Dacarbazine.
Related Therapeutic Areas
Sponsors
Leads: IDEAYA Biosciences