Spots Global Cancer Trial Database for IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma
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Trial Identification
Brief Title: IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma
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)
Study ID: NCT05987332
Conditions
Study Description
Brief 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).
Detailed Description: This study is designed as a multi-stage Phase 2 study within a Phase 3 study to evaluate the safety, tolerability, pharmacokinetics, dose-exposure relationship, and anti-tumor activity of IDE196 in combination with crizotinib compared to the comparator arm of investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine). The Phase 2a dose optimization stage will evaluate two doses of IDE196 in combination with crizotinib compared to the comparator arm. Participants will be randomized to the three treatment arms. At the point of optimal IDE196 + crizotinib dose selection, the other dose arm will be dropped with discontinuation of enrollment to that arm. Participants receiving the IDE196 dose (in combination with crizotinib) that is not selected, will be offered the choice to remain on the same dose or change to the chosen optimal dose. The optimal dose will be chosen to complete the Phase 2b portion. The Phase 2b part of the study will continue to enroll the chosen combination dose of IDE196 + crizotinib compared with the comparator arm. Participants will be randomized to the two treatment arms. The Phase 3 part of the study will continue to enroll the chosen combination dose of IDE196 + crizotinib compared with the comparator arm. Participants will be randomized to the two treatment arms.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Mayo Clinic, Rochester, Minnesota, United States
Washington University School of Medicine, Saint 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- Tennessee Oncology, Nashville, Tennessee, 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
Alfred Health, Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital, Perth, Western Australia, Australia
Queen Elizabeth Hospital, Adelaide, , Australia
Cliniques Universitaires Saint Luc, Brussels, , Belgium
Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal- CHUM, Montréal, Quebec, Canada
The Leon Berard Center, Lyon, , France
Institut Curie, Paris, , France
NCT Heidelberg, Heidelberg, Baden- Württemberg, Germany
Universitätsklinikum Essen (AöR), Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Köln, Köln, 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, Milano, , Italy
Istituto Nazionale dei Tumori Fondazione Pascale, Napoli, , 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, Gdańsk, , 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, Sevilla, , Spain
Hospital General Universitario Valencia, Valencia, , Spain
Dermatologische Klinik, USZ Flughafen Geschoss 7 - Klinische Forschung, Zuerich, , Switzerland
The Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Mount Vernon Cancer Centre East & North Herts NHS Trust, Northwood, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust, Wirral, , United Kingdom
Contact Details
Name: Darrin Beaupre, MD, Ph.D
Affiliation: IDEAYA Biosciences
Role: STUDY_DIRECTOR
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