IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma
NCT ID: NCT05987332
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2/PHASE3
420 participants
INTERVENTIONAL
2023-10-31
2028-01-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
NCT05907954
Neoadjuvant Darovasertib in Primary Uveal Melanoma
NCT07015190
Neoadjuvant/Adjuvant Trial of Darovasertib in Ocular Melanoma
NCT05187884
Durvalumab (MEDI4736) Plus Cediranib in Patients With Metastatic Uveal Melanoma
NCT04184518
Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal Melanoma in the Liver
NCT03472586
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
IDE196
Dosed orally, twice daily
Crizotinib
Dosed orally, twice daily
Phase 2b / 3 Chosen Combination dose of IDE196 + crizotinib
Chosen combination dose of IDE196 + crizotinib will be tested in additional participants.
IDE196
Dosed orally, twice daily
Crizotinib
Dosed orally, twice daily
Phase 2a / 2b / 3 Comparator Arm
Participants will receive investigator's choice of Pembrolizumab, Ipilimumab + Nivolumab, or Dacarbazine.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Concurrent malignant disease
* AEs from prior anti-cancer therapy that have not resolved to Grade ≤1
* Symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require corticosteroids
* High risk of syncope
* Known AIDS related illness or active Hep B/C
* Active adrenal insufficiency, active colitis, or active inflammatory bowel disease
* History of interstitial lung disease, active pneumonitis, or history of pneumonitis
* Active infection requiring systemic antibiotic therapy
* Use of hematopoietic colony-stimulating factors (CSF) prior to start of study drug
* Females who are pregnant or breastfeeding
* History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies
* Contraindication for treatment with investigator's choice therapies as per applicable labelling
* History of stroke within the last 6 months of the first dose of study drug
* Has any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the opinion of the investigator, would make the participant inappropriate for entry into the study, including institutionalization on the basis of an official or court order
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IDEAYA Biosciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hetal Patel, MD, MSHS, CHCQM
Role: STUDY_DIRECTOR
IDEAYA Biosciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: backup
Role: primary
Role: primary
Lucy Kennedy, MD
Role: primary
SCRI Oncology Partners
Role: primary
Roberts-Thomson, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IDE196-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.