Uveal MelanomaPhase 2NCT05907954
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
A Phase 2 study testing Darovasertib in people with Uveal Melanoma, run by IDEAYA Biosciences at 18 sites in 7 countries.
Trial summary
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 18 sitesin 7 countries
- Study dates
- 3 Jul 2023to 30 Apr 2030
- Phase
- Phase 2
- 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 localized uveal melanoma requiring either enucleation or plaque brachytherapy
- Cohort 3 (patients with small UM tumors) - clinically diagnosed uveal (not iris) melanoma that is < 4 mm in thickness requiring treatment
- Able to dose orally
- ECOG Performance status of 0-1
- No other significant underlying ocular disease
- Adequate organ function
- Not pregnant/nursing or planning to become pregnant. Willing to use birth control
Who cannot join
- Previous treatment with a Protein Kinase C (PKC) inhibitor
- Concurrent malignant disease
- Active HIV infection or Hep B/C
- Malabsorption disorder
- Unable to discontinue prohibited medication
- Impaired cardiac function or clinically significant cardiac disease
- Any other condition which may interfere with study interpretation or results
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
United States10 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
The Cancer and Hematology Centers
Grand Rapids, Michigan, 49546
Moores Cancer Center
La Jolla, California, 92093
Northwell
Manhasset, New York, 11030
University of Miami
Miami, Florida, 33146
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Stanford Cancer Institute
Palo Alto, California, 94305
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Mayo Clinic Rochester
Rochester, Minnesota, 55905
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Australia2 sites
Alfred Health
Melbourne, Victoria, 3004
St. Vincent's Health Sydney
Sydney, New South Wales, 2010
Italy2 sites
Fondazione IRCCS Istituto Nazionale Tumori
Milan, 20133
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
About this study
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
Read the detailed description
Phase 2 multi-center open-label IDE196 study in patients with primary uveal melanoma (UM) requiring either enucleation or plaque brachytherapy. Patients will be treated in neoadjuvant setting up to 12 months (or maximum benefit) followed by primary local therapy. An additional 6 months of adjuvant treatment may be given to some patients. All patients will have long term follow-up (up to 3 years) to assess visual outcome, disease recurrence, and development of metastatic disease.
- Conditions
- Uveal Melanoma
- Being tested
- Darovasertib
- Keywords
- Uveal Melanoma, Plaque brachytherapy, Enucleation, Neoadjuvant, Adjuvant, Protein Kinase C, Ophthalmology, Ocular Oncology, Darovasertib, IDE196, Ocular melanoma, Choroid melanoma, Plaque, Brachytherapy
- Medical subject headings
- Uveal Melanoma, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarovasertibDrug
Also called IDE196, LXS196
Oral, potent, selective inhibitor of Protein Kinase C
| Study group | Role | What they receive |
|---|---|---|
| darovasertib | Experimental | IDE196 (darovasertib) oral open label Receives: Drug: Darovasertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) and significant laboratory abnormalities
Treatment emergent adverse events will be summarized by all AEs, all Grade 3-4-5 AEs, all treatment related AEs, all AEs leading to study drug modifications or discontinuations, all SAEs. Lab results will be summarized by change from baseline values, frequency of newly occurring on-treatment Grade 3 or 4 events; worst on-treatment value compared to baseline.
Measured: from first dose to 28 days after last dose of therapy, approximately 18 months
Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation
Rate of eye salvage as determined by the ocular oncologist based on tumor response to neoadjuvant therapy
Measured: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months
Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose
Change in modeled radiation dose at critical eye structures before and after neoadjuvant therapy
Measured: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months
Cohort 3 (patients with small UM tumors): Number of patients with clinical benefit per protocol-defined UM response criteria
Proportion of patients with clinical benefit rate (CBR) defined as complete response (CR) + partial response (PR) + stable disease (SD) for ≥ 12 weeks per UM response criteria
Measured: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months
Secondary outcomes (5)
Evaluate tumor response to neoadjuvant IDE196
Measurement of tumor diameter and thickness before and after neoadjuvant therapy with IDE196, specifically as measured by ocular ultrasound, evaluating largest basal diameter and apical thickness of the uveal melanoma (measured in millimeters)
Measured: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months
Assessment of visual acuity loss
Best corrected visual acuity loss over time
Measured: from time of primary local therapy to one year after surgery, approximately 12 months
Rate of local disease recurrence
Evaluate uveal melanoma progression or recurrence
Measured: from date of primary local therapy to end of follow-up, approximately 36 months
Cohort 3 (patients with small UM tumors): Effect of neoadjuvant IDE196 therapy on the natural history of small UM tumors
Time from first dose of neoadjuvant to primary local therapy
Measured: from first dose of neoadjuvant to primary local therapy, approximately 12 months
Cohort 3 (patients with small UM tumors): Efficacy of neoadjuvant IDE196 therapy on small UM tumors
Tumor response (complete response and partial response) as measured by protocol-defined UM response criteria
Measured: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start3 Jul 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2030 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IDEAYA Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jasgit Sachdev, MD, Study director, IDEAYA Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907954
- Sponsor's protocol ID
- IDE196-009
- Status last verified
- Mar 2026
- First submitted
- 6 Jun 2023
- Last updated
- 16 Mar 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
- ClinicalTrials.gov ID
- NCT05907954
- Acronym / sponsor ID
- IDE196-009
- Conditions
- Uveal Melanoma
- Keywords
- Uveal Melanoma, Plaque brachytherapy, Enucleation, Neoadjuvant, Adjuvant, Protein Kinase C, Ophthalmology, Ocular Oncology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- IDEAYA BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 18 Jun 2023 (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.
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
Detailed description
Phase 2 multi-center open-label IDE196 study in patients with primary uveal melanoma (UM) requiring either enucleation or plaque brachytherapy. Patients will be treated in neoadjuvant setting up to 12 months (or maximum benefit) followed by primary local therapy. An additional 6 months of adjuvant treatment may be given to some patients. All patients will have long term follow-up (up to 3 years) to assess visual outcome, disease recurrence, and development of metastatic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| darovasertib | Experimental | Drug: DarovasertibIDE196 (darovasertib) oral open label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy
- Cohort 3 (patients with small UM tumors) - clinically diagnosed uveal (not iris) melanoma that is < 4 mm in thickness requiring treatment
- Able to dose orally
- ECOG Performance status of 0-1
- No other significant underlying ocular disease
Key exclusion criteria (7 listed)
- Previous treatment with a Protein Kinase C (PKC) inhibitor
- Concurrent malignant disease
- Active HIV infection or Hep B/C
- Malabsorption disorder
- Unable to discontinue prohibited medication
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: IDE196, LXS196Oral, potent, selective inhibitor of Protein Kinase C | Drug | darovasertib |
Primary outcome
Incidence of Adverse Events (AEs) and significant laboratory abnormalities
Time frame: from first dose to 28 days after last dose of therapy, approximately 18 months
Treatment emergent adverse events will be summarized by all AEs, all Grade 3-4-5 AEs, all treatment related AEs, all AEs leading to study drug modifications or discontinuations, all SAEs. Lab results will be summarized by change from baseline values, frequency of newly occurring on-treatment Grade 3 or 4 events; worst on-treatment value compared to baseline.
Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation
Time frame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months
Rate of eye salvage as determined by the ocular oncologist based on tumor response to neoadjuvant therapy
Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose
Time frame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months
Change in modeled radiation dose at critical eye structures before and after neoadjuvant therapy
Cohort 3 (patients with small UM tumors): Number of patients with clinical benefit per protocol-defined UM response criteria
Time frame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months
Proportion of patients with clinical benefit rate (CBR) defined as complete response (CR) + partial response (PR) + stable disease (SD) for ≥ 12 weeks per UM response criteria
5 secondary outcomes
Evaluate tumor response to neoadjuvant IDE196
Time frame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months
Assessment of visual acuity loss
Time frame: from time of primary local therapy to one year after surgery, approximately 12 months
Rate of local disease recurrence
Time frame: from date of primary local therapy to end of follow-up, approximately 36 months
Cohort 3 (patients with small UM tumors): Effect of neoadjuvant IDE196 therapy on the natural history of small UM tumors
Time frame: from first dose of neoadjuvant to primary local therapy, approximately 12 months
Cohort 3 (patients with small UM tumors): Efficacy of neoadjuvant IDE196 therapy on small UM tumors
Time frame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months
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 16 Mar 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. This study is not recruiting at the moment.
Jasgit Sachdev, MD study director
IDEAYA Biosciences
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darovasertib in people with Uveal Melanoma, run by IDEAYA Biosciences at 18 sites in 7 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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Australia, Italy, Canada, France and 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) and significant laboratory abnormalities (time frame: from first dose to 28 days after last dose of therapy, approximately 18 months). The study lists 4 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 16 Mar 2026.