Uveal MelanomaPhase 3NCT07015190
Neoadjuvant Darovasertib in Primary Uveal Melanoma
A Phase 3 study testing Darovasertib and Primary Local Therapy in people with Uveal Melanoma, run by IDEAYA Biosciences at 94 sites in 21 countries.
Trial summary
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- Darovasertib and Primary Local Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 94 sitesin 21 countries
- Study dates
- 25 Jan 2026to Mar 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary non-metastatic uveal melanoma
- 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
Who cannot join
- Previous treatment for UM
- 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
Trial locations and contacts
94 sites in 21 countries. Contact the study team or a site near you to ask about taking part.
Mwe Mwe Chao, MD contact
94 sites in 21 countries
United States35 sites, 35 recruiting
- Not yet recruiting
W Kellogg Eye Center
Ann Arbor, Michigan, 48105
Hakan Demirci, MD Principal Investigator
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Sapna Patel, MD Principal Investigator
- Recruiting
Austin Retina Associates - Central
Austin, Texas, 78705
Shelley Ghafoori, MD Principal Investigator
- Recruiting
Wilmer Eye Institute
Baltimore, Maryland, 21287-0005
James Handa, MD Principal Investigator
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kamaneh Montazeri, MD Principal Investigator
- Not yet recruiting
Cole Eye Institute-9500 Euclid Ave
Cleveland, Ohio, 44195
Lucy Kennedy, MD Principal Investigator
- Not yet recruiting
Ohio State Eye and Ear Institute
Columbus, Ohio, 43212
Colleen Cebulla, MD Principal Investigator
- Recruiting
Texas Retina Associates - Dallas
Dallas, Texas, 75231
Timothy Fuller, MD Principal Investigator
- Recruiting
University of Texas Southwestern Medical Center-5323 Harry Hines Blvd
Dallas, Texas, 75390-9057
Sanjay Chandrasekaran, MD Principal Investigator
- Not yet recruiting
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113-2791
Ryan Weight, MD Principal Investigator
- Not yet recruiting
Augusta Health, Center for Cancer and Blood Disorders
Fishersville, Virginia, 22939
Kelvin Rayborn, MD Principal Investigator
- Recruiting
The Cancer and Hematology Centers of West Michigan (CHCWM)
Grand Rapids, Michigan, 49503
Sreenivasa Chandana, MD Principal Investigator
- Not yet recruiting
Retina Consultants of Texas - (Houston)
Houston, Texas, 77030-2727
Amy Schefler, MD Principal Investigator
- Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Bently Doonan, MD Principal Investigator
- Not yet recruiting
UCSD Moores Cancer Center
La Jolla, California, 92093
Gregory Daniels, MD Principal Investigator
- Not yet recruiting
Jules Stein Eye Institute
Los Angeles, California, 90024
Tara McCannel, MD Principal Investigator
- Not yet recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Gino In, MD, Principal Investigator
- Not yet recruiting
University of Wisconsin Health
Madison, Wisconsin, 53705-3644
Michael Altaweel, MD Principal Investigator
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Meredith McKean, MD Principal Investigator
- Not yet recruiting
Vanderbilt Eye Institute
Nashville, Tennessee, 37232
Paul Sternberg, MD, Principal Investigator
- Recruiting
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Benjamin Izar, MD Principal Investigator
- Not yet recruiting
Memorial Sloan Kettering Cancer Center - 1275 York Ave
New York, New York, 10065-6635
Jasmine Francis, MD Principal Investigator
- Not yet recruiting
Northwell Health Cancer Institute
New York, New York, 11042
Shaheer Khan, MD Principal Investigator
- Not yet recruiting
Retina Consultants of Oklahoma
Oklahoma City, Oklahoma, 73112
Brian Firestone, MD, Principal Investigator
- Not yet recruiting
TIERING Percentiles
Omaha, Nebraska, 68105
Pukhraj Rishi, MD Principal Investigator
- Not yet recruiting
University of California Irvine Medical Center
Orange, California, 92868
Poorva Vaidya, MD Principal Investigator
- Recruiting
Stanford Comprehensive Cancer Center
Palo Alto, California, 94304
Pauline Funchain, MD Principal Investigator
- Not yet recruiting
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, 19107
Marlana Orloff, MD Principal Investigator
- Not yet recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Yana Najjar, MD Principal Investigator
- Recruiting
Kaiser Permanente-Riverside Medical Center
Riverside, California, 92505-3043
Helen Moon, MD Principal Investigator
- Recruiting
Mayo Clinic - PPDS
Rochester, Minnesota, 55905
Lauren Dalvin, MD Principal Investigator
- Not yet recruiting
UCSF Wayne and Gladys Valley Center for Vision
San Francisco, California, 94143
Armin Afshar, MD, Principal Investigator
- Recruiting
Mayo Clinic Scottsdale - PPDS
Scottsdale, Arizona, 85259
Odette Houghton, MD Principal Investigator
- Not yet recruiting
USF Health Eye Institute
Tampa, Florida, 33612-6601
Jorge Agi, MD Principal Investigator
- Not yet recruiting
Moffit Cancer Center
Tampa, Florida, 33612
Nikhil Khushalani, MD, Principal Investigator
Germany10 sites, 10 recruiting
- Not yet recruiting
Charité - Universitätsmedizin Berlin
Berlin, 12203
Antonia Joussen, MD Principal Investigator
- Not yet recruiting
Universitätsklinikum Bonn
Bonn, 53127
Thomas Ach, MD Principal Investigator
- Not yet recruiting
Städtisches Klinikum Dessau
Dessau, Saxony-Anhalt, 6847
Lothar Krause, MD Principal Investigator
- Not yet recruiting
Hautklinik Erlangen
Erlangen, Bavaria, 91054
Carola Berking, MD Principal Investigator
- Not yet recruiting
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147
Halime Kalkavan, MD Principal Investigator
- Not yet recruiting
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, 23562
Svenja Sonntag, Principal Investigator, MD
- Not yet recruiting
Universitätsklinikum Giessen und Marburg - Marburg (UKGM)
Marburg, 35043
Walter Sekundo, MD Principal Investigator
- Not yet recruiting
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076
Daniela Süsskind, MD Principal Investigator
- Not yet recruiting
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89075
Armin Wolf, MD Principal Investigator
- Not yet recruiting
Universitätsklinikum Würzburg
Würzburg, 97080
Andreas Berlin, MD Principal Investigator
Italy6 sites, 6 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134
Cinzia Mazzini, MD Principal Investigator
- Not yet recruiting
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
Milan, Milan, 20157
Marco Pellegrini, MD Principal Investigator
- Not yet recruiting
Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
Naples, Campania, 80131
Paolo Ascierto, MD Principal Investigator
- Not yet recruiting
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Perugia, Perugia
Mario Mandalà, MD Principal Investigator
- Not yet recruiting
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Pisa, 56124
Federica Genovesi Ebert, MD Principal Investigator
- Not yet recruiting
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome, 168
Ernesto Rossi, MD Principal Investigator
Spain6 sites, 6 recruiting
- Not yet recruiting
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 8907
Jose Maria Caminal Mitjana, MD Principal Investigator
- Recruiting
Clinica Universidad Navarra
Pamplona, Navarre, 31008
Alfredo Garcia Layana, MD Principal Investigator
- Recruiting
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
Maria José Blanco Teijeiro, MD Principal Investigator
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Francisco Espejo-Arjona, MD Principal Investigator
- Not yet recruiting
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Valencia, 46026
Rafael Martínez-Costa Pérez, MD Principal Investigator
- Recruiting
Hospital Clinico Universitario de Valladolid
Valladolid, Valladolid, 47003
Ciro Garcia-Alvarez, MD Principal Investigator
France5 sites, 5 recruiting
- Not yet recruiting
Centre Retine Gallien - Bordeaux
Bordeaux, Gironde, 33000
Laurence Rosier, MD Principal Investigator
- Not yet recruiting
CHU de Nice-Hôpital Pasteur
Nice, Alpes-Maritimes, 6000
Sacha Nahon-Estève, MD Principal Investigator
- Not yet recruiting
Institut Curie - Hôpital de Paris
Paris, Paris, 75248
Alexandre Matet, MD Principal Investigator
- Not yet recruiting
Centre Hospitalier National D'ophtalmologie Des Quinze Vingts
Paris, 75571
Sarah Tick, MD Principal Investigator
- Not yet recruiting
CHU de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, 35000
Frederic Mouriaux, MD Principal Investigator
Australia4 sites, 4 recruiting
- Not yet recruiting
Gallipoli Medical Research Foundation
Greenslopes, Queensland, QLD 4120
Victoria Atkinson, MD, Principal Investigator
- Not yet recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Mark Shackleton, MD Principal Investigator
- Not yet recruiting
The Crown Princess Mary Cancer Centre (Westmead Hospital), NSW 214
Westmead, NSW 2145
Matteo Carlino, MD, Principal Investigator
- Not yet recruiting
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Rachel Roberts-Thomson, MD Principal Investigator
Austria3 sites, 3 recruiting
- Not yet recruiting
LKH-Universitätsklinikum Graz
Graz, 8036
Thomas Georgi, MD Principal Investigator
- Not yet recruiting
Universitätsklinikum Innsbruck
Innsbruck, 6020
Matus Rehak, MD Principal Investigator
- Not yet recruiting
Universitätsklinikum AKH Wien
Vienna, 1090
Roman Dunavölgyi, MD Principal Investigator
Greece3 sites, 3 recruiting
- Not yet recruiting
PAGNI-University General Hospital of Heraklion
Heraklion, Irakleio, 715 00
Efstathios Detorakis, MD Principal Investigator
- Not yet recruiting
University General Hospital of Larissa
Larissa, Larissa, 41 110
Sofia Androudi, MD Principal Investigator
- Not yet recruiting
AHEPA University General Hospital of Thessaloniki
Thessaloniki, Thessaloníki, 546 36
Konstantinos Boboridis, MD Principal Investigator
Poland3 sites, 3 recruiting
- Not yet recruiting
Uniwersyteckie Centrum Kliniczne w Gdansku - Debinki 7
Gdansk, Pomeranian Voivodeship, 80-214
Kamil Drucis, MD Principal Investigator
- Not yet recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu- Dluga 1/2
Poznan, Greater Poland Voivodeship, 61-848
Iwona Rospond-Kubiak, MD Principal Investigator
- Not yet recruiting
WIM-PIB, Centralny Szpital Kliniczny MON
Warsaw, Masovian Voivodeship, 04-141
Izabela Nowak-Gospodarowicz, MD Principal Investigator
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
University College Hospital
London, NW1 2BU
Heather Shaw, MD Principal Investigator
- Not yet recruiting
Clatterbridge Cancer Centre - Liverpool - NWCRN - PPDS
Metropolitan Borough of Wirral, Merseyside, CH63 4JY
Joseph Sacco, MD Principal Investigator
- Not yet recruiting
Weston Park Cancer Centre - PPDS
Sheffield, S10 2TF
Krishnakumar Garadi, MD Principal Investigator
Belgium2 sites, 2 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc - PPDS
Brussels, 1200
Jean-Francois Baurain, MD Principal Investigator
- Not yet recruiting
UZ Leuven - PPDS
Leuven, 3000
Joachim Van Calster, MD Principal Investigator
Canada2 sites, 2 recruiting
- Not yet recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
John Walker, MD, Principal Investigator
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Marcus Butler, MD Principal Investigator
Denmark2 sites, 2 recruiting
- Not yet recruiting
Aarhus Universitetshospital
Aarhus, Central Jutland, 8200
Peter Skov Jensen, MD Principal Investigator
- Not yet recruiting
Rigshospitalet
Copenhagen O, Capital, 2100
Jens Kiilgaard, MD Principal Investigator
Israel2 sites, 2 recruiting
- Recruiting
Hadassah Medical Center - PPDS
Jerusalem, Jerusalem, 91120
Shahar Frenkel, MD Principal Investigator
- Recruiting
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Central District, 5262100
Vicktoria Vishnevskia-Dai, MD Principal Investigator
Switzerland2 sites, 2 recruiting
- Recruiting
Universitätsspital Basel
Basel, 4031
Andreas Schmitt, MD Principal Investigator
- Recruiting
Universitätsspital Zürich
Zurich, 8091
Egle Ramelyte, MD Principal Investigator
Czechia1 site, 1 recruiting
- Recruiting
Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha
Prague, Prague, 169 02
Zuzana Hradcova, MD Principal Investigator
Estonia1 site, 1 recruiting
- Not yet recruiting
East Tallinn Central Hospital-Pärnu road 104
Tallinn, Harju, 11312
Elen Vettus, MD Principal Investigator
Netherlands1 site, 1 recruiting
- Not yet recruiting
Erasmus MC
Rotterdam, South Holland, 3015 GD
Emine Kiliç-Ciğirci, MD Principal Investigator
New Zealand1 site, 1 recruiting
- Not yet recruiting
Auckland Eye
Auckland, Auckland, 1050
Riyaz Bhikoo, MD Principal Investigator
Slovakia1 site, 1 recruiting
- Not yet recruiting
Fakultna nemocnica s poliklinikou F. D. Roosevelta
Banská Bystrica, 975 17
Ladislav Janco, MD Principal Investigator
Slovenia1 site, 1 recruiting
- Not yet recruiting
Institute of Oncology Ljubljana
Ljubljana, Ljubljana, 1000
Janja Ocvirk, MD Principal Investiagtor
About this study
Official title: A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
Read the detailed description
The study is divided into 2 cohorts of patients with primary uveal melanoma requiring either plaque brachytherapy or enucleation.
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
- Uveal Melanoma
- Being tested
- Darovasertib, Primary Local Therapy
- Keywords
- Uveal Melanoma, Plaque Brachytherapy, Enucleation, Neoadjuvant, Darovasertib, IDE 196, Ocular Melanoma, Choroidal Melanoma, Ophthalmology, Ocular Oncology, Melanoma, Protein Kinase C, GNAQ, GNA11
- Medical subject headings
- Uveal Melanoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarovasertibDrug
Also called IDE 196
Dosed orally, twice daily (28-day/ cycle
Primary Local TherapyProcedure or surgery
Plaque Brachytherapy or Enucleation
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Darovasetib followed by definitive primary local therapy (i.e., PB, proton beam radiation, or enucleation) Receives: Drug: Darovasertib |
| Control Arm | Active comparator | Immediate Primary Local therapy Receives: Procedure: Primary Local Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm
Loss of Best Corrected Visual Acuity (BCVA) of ≥ 15 letters using Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA
Measured: Approximately 3 years
Cohort 2: To demonstrate the ability to salvage the eye and prevent enucleation in the Treatment Arm
Eye preservation rate
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start25 Jan 2026
- Primary completionOct 2030 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- More trials run by IDEAYA BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IDEAYA Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015190
- Sponsor's protocol ID
- IDE196-010
- Status last verified
- Sep 2025
- First submitted
- 3 Jun 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)
- ClinicalTrials.gov ID
- NCT07015190
- Acronym / sponsor ID
- IDE196-010
- Conditions
- Uveal Melanoma
- Keywords
- Uveal Melanoma, Plaque Brachytherapy, Enucleation, Neoadjuvant, Darovasertib, IDE 196, Ocular Melanoma, Choroidal Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- IDEAYA BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2026 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
Detailed description
The study is divided into 2 cohorts of patients with primary uveal melanoma requiring either plaque brachytherapy or enucleation.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: DarovasertibDarovasetib followed by definitive primary local therapy (i.e., PB, proton beam radiation, or enucleation) |
| Control Arm | Active comparator | Procedure: Primary Local TherapyImmediate Primary Local therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary non-metastatic uveal melanoma
- 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
Key exclusion criteria (5 listed)
- Previous treatment for UM
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DarovasertibAlso: IDE 196Dosed orally, twice daily (28-day/ cycle | Drug | Treatment Arm |
| Primary Local TherapyPlaque Brachytherapy or Enucleation | Procedure or surgery | Control Arm |
Primary outcome
Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm
Time frame: Approximately 3 years
Loss of Best Corrected Visual Acuity (BCVA) of ≥ 15 letters using Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA
Cohort 2: To demonstrate the ability to salvage the eye and prevent enucleation in the Treatment Arm
Time frame: Approximately 2 years
Eye preservation rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mwe Mwe Chao, MD contact
94 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Darovasertib and Primary Local Therapy in people with Uveal Melanoma, run by IDEAYA Biosciences at 94 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in United States, Germany, Italy, Spain, France and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IDEAYA Clinical Trials (+1-855-433-2246, IDEAYAClinicalTrials@ideayabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm (time frame: Approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.