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
PHASE3
520 participants
INTERVENTIONAL
2025-10-31
2031-03-31
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
IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma
NCT05987332
Neoadjuvant/Adjuvant Trial of Darovasertib in Ocular Melanoma
NCT05187884
Adjuvant Tebentafusp in High Risk Ocular Melanoma
NCT06246149
Durvalumab (MEDI4736) Plus Cediranib in Patients With Metastatic Uveal Melanoma
NCT04184518
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In cohort 1, patients in the treatment arm will receive neoadjuvant darovasertib followed by plaque brachytherapy compared to immediate plaque brachytherapy (control arm).
In cohort 2, the treatment arm will receive neoadjuvant darovasertib followed by definitive primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation). Subjects in the control arm will go onto immediate enucleation.
Subjects will then receive primary local therapy following neoadjuvant darovasertib.
All patients will be followed for up to 3 years to assess longer term outcomes such as vision and tumor recurrence.
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
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment Arm
Darovasetib followed by definitive primary local therapy (i.e., PB, proton beam radiation, or enucleation)
Darovasertib
Dosed orally, twice daily (28-day/ cycle
Control Arm
Immediate Primary Local therapy
Primary Local Therapy
Plaque Brachytherapy or Enucleation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Darovasertib
Dosed orally, twice daily (28-day/ cycle
Primary Local Therapy
Plaque Brachytherapy or Enucleation
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
* Able and willing to provide written, informed consent before initiation of any study-related procedures, and in the opinion of the Investigator, to comply with all study requirements
* ECOG 0 or 1
* Adequate organ function
Exclusion Criteria
* Evidence of metastatic UM
* Attributes that necessitate enucleation regardless of response to therapy
* Evidence of progressive secondary underlying ocular disease that would confound longitudinal VA assessments
* Presence of a malignant disease other than the one being treated in this study
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.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic Scottsdale - PPDS
Scottsdale, Arizona, United States
UCSD Moores Cancer Center
La Jolla, California, United States
University of California Irvine Medical Center
Orange, California, United States
Stanford Comprehensive Cancer Center
Palo Alto, California, United States
Kaiser Permanente-Riverside Medical Center
Riverside, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Wilmer Eye Institute
Baltimore, Maryland, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
W Kellogg Eye Center
Ann Arbor, Michigan, United States
The Cancer and Hematology Centers of West Michigan (CHCWM)
Grand Rapids, Michigan, United States
Mayo Clinic - PPDS
Rochester, Minnesota, United States
TIERING Percentiles
Omaha, Nebraska, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center - 1275 York Ave
New York, New York, United States
Cole Eye Institute-9500 Euclid Ave
Cleveland, Ohio, United States
Ohio State Eye and Ear Institute
Columbus, Ohio, United States
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Southeastern Retina Associates-Hixson
Hixson, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Austin Retina Associates - Central
Austin, Texas, United States
Texas Retina Associates - Dallas
Dallas, Texas, United States
University of Texas Southwestern Medical Center-5323 Harry Hines Blvd
Dallas, Texas, United States
Augusta Health, Center for Cancer and Blood Disorders
Fishersville, Virginia, United States
University of Wisconsin Health
Madison, Wisconsin, United States
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
LKH-Universitätsklinikum Graz
Graz, , Austria
Universitätsklinikum Innsbruck
Innsbruck, , Austria
Universitätsklinikum AKH Wien
Vienna, , Austria
Cliniques Universitaires Saint-Luc - PPDS
Brussels, , Belgium
UZ Leuven - PPDS
Leuven, , Belgium
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha
Prague, Prague, Czechia
Rigshospitalet
Copenhagen O, Capital, Denmark
Aarhus Universitetshospital
Aarhus, Central Jutland, Denmark
East Tallinn Central Hospital-Pärnu road 104
Tallinn, Harju, Estonia
CHU de Nice-Hôpital Pasteur
Nice, Alpes-Maritimes, France
Centre Retine Gallien - Bordeaux
Bordeaux, Gironde, France
CHU de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, France
Institut Curie - Hôpital de Paris
Paris, Paris, France
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Städtisches Klinikum Dessau
Dessau, Saxony-Anhalt, Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, , Germany
Universitätsklinikum Giessen und Marburg - Marburg (UKGM)
Marburg, , Germany
Universitätsklinikum Würzburg
Würzburg, , Germany
PAGNI-University General Hospital of Heraklion
Heraklion, Irakleio, Greece
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Central District, Israel
Hadassah Medical Center - PPDS
Jerusalem, Jerusalem, Israel
Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
Napoli, Campania, Italy
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
Milan, Milan, Italy
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Perugia, Perugia, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Pisa, , Italy
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome, , Italy
Erasmus MC
Rotterdam, South Holland, Netherlands
Uniwersytecki Szpital Kliniczny w Poznaniu- Dluga 1/2
Poznan, Greater Poland Voivodeship, Poland
WIM-PIB, Centralny Szpital Kliniczny MON
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne w Gdansku - Debinki 7
Gdansk, Pomeranian Voivodeship, Poland
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Clinica Universidad Navarra
Pamplona, Navarre, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Valencia, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Valladolid, Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Universitätsspital Basel
Basel, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
Clatterbridge Cancer Centre - Liverpool - NWCRN - PPDS
Metropolitan Borough of Wirral, Merseyside, United Kingdom
University College Hospital
London, , 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.
Odette Houghton, MD Principal Investigator
Role: primary
Gregory Daniels, MD Principal Investigator
Role: primary
Poorva Vaidya, MD Principal Investigator
Role: primary
Pauline Funchain, MD Principal Investigator
Role: primary
Helen Moon, MD Principal Investigator
Role: primary
Sapna Patel, MD Principal Investigator
Role: primary
Ryan Weight, MD Principal Investigator
Role: primary
Bently Doonan, MD Principal Investigator
Role: primary
James Handa, MD Principal Investigator
Role: primary
Ivana Kim, MD Principal Investigator
Role: primary
Hakan Demirci, MD Principal Investigator
Role: primary
Sreenivasa Chandana, MD Principal Investigator
Role: primary
Lauren Dalvin, MD Principal Investigator
Role: primary
Pukhraj Rishi, MD Principal Investigator
Role: primary
Mariam El-Ashmawy, MD Principal Investigator
Role: primary
Jasmine Francis, MD Principal Investigator
Role: primary
Lucy Kennedy, MD Principal Investigator
Role: primary
Colleen Cebulla, MD Principal Investigator
Role: primary
Marlana Orloff, MD Principal Investigator
Role: primary
Yana Najjar, MD Principal Investigator
Role: primary
Asghar Haider, MD Principal Investigator
Role: primary
Meredith McKean, MD Principal Investigator
Role: primary
Shelley Ghafoori, MD Principal Investigator
Role: primary
Timothy Fuller, MD Principal Investigator
Role: primary
James Harbour, MD Principal Investigator
Role: primary
Kelvin Rayborn, MD Principal Investigator
Role: primary
Michael Altaweel, MD Principal Investigator
Role: primary
Rachel Roberts-Thomson, MD Principal Investigator
Role: primary
Mark Shackleton, MD Principal Investigator
Role: primary
Thomas Georgi, MD Principal Investigator
Role: primary
Matus Rehak, MD Principal Investigator
Role: primary
Roman Dunavölgyi, MD Principal Investigator
Role: primary
Jean-Francois Baurain, MD Principal Investigator
Role: primary
Joachim Van Calster, MD Principal Investigator
Role: primary
Marcus Butler, MD Principal Investigator
Role: primary
Zuzana Hradcova, MD Principal Investigator
Role: primary
Jens Kiilgaard, MD Principal Investigator
Role: primary
Peter Skov Jensen, MD Principal Investigator
Role: primary
Elen Vettus, MD Principal Investigator
Role: primary
Sacha Nahon-Estève, MD Principal Investigator
Role: primary
Laurence Rosier, MD Principal Investigator
Role: primary
Frederic Mouriaux, MD Principal Investigator
Role: primary
Alexandre Matet, MD Principal Investigator
Role: primary
Daniela Süsskind, MD Principal Investigator
Role: primary
Armin Wolf, MD Principal Investigator
Role: primary
Halime Kalkavan, MD Principal Investigator
Role: primary
Lothar Krause, MD Principal Investigator
Role: primary
Antonia Joussen, MD Principal Investigator
Role: primary
Thomas Ach, MD Principal Investigator
Role: primary
Svenja Sonntag, Principal Investigator, MD
Role: primary
Walter Sekundo, MD Principal Investigator
Role: primary
Andreas Berlin, MD Principal Investigator
Role: primary
Efstathios Detorakis, MD Principal Investigator
Role: primary
Vicktoria Vishnevskia-Dai, MD Principal Investigator
Role: primary
Shahar Frenkel, MD Principal Investigator
Role: primary
Paolo Ascierto, MD Principal Investigator
Role: primary
Marco Pellegrini, MD Principal Investigator
Role: primary
Mario Mandalà, MD Principal Investigator
Role: primary
Cinzia Mazzini, MD Principal Investigator
Role: primary
Federica Genovesi Ebert, MD Principal Investigator
Role: primary
Ernesto Rossi, MD Principal Investigator
Role: primary
Emine Kiliç-Ciğirci, MD Principal Investigator
Role: primary
Iwona Rospond-Kubiak, MD Principal Investigator
Role: primary
Izabela Nowak-Gospodarowicz, MD Principal Investigator
Role: primary
Kamil Drucis, MD Principal Investigator
Role: primary
Maria José Blanco Teijeiro, MD Principal Investigator
Role: primary
Jose Maria Caminal Mitjana, MD Principal Investigator
Role: primary
Alfredo Garcia Layana, MD Principal Investigator
Role: primary
Rafael Martínez-Costa Pérez, MD Principal Investigator
Role: primary
Ciro Garcia-Alvarez, MD Principal Investigator
Role: primary
Francisco Espejo-Arjona, MD Principal Investigator
Role: primary
Alexandra Steinemann-Inauen, MD Principal Investigator
Role: primary
Egle Ramelyte, MD Principal Investigator
Role: primary
Joseph Sacco, MD Principal Investigator
Role: primary
Heather Shaw, MD Principal Investigator
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IDE196-010
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.