At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Darovasertib (drug), Primary Local Therapy (procedure)
- How long the study runs
- Study runs about 62 months (dates as stated)
- About the drug or intervention
- Darovasertib — drug: Dosed orally, twice daily (28-day/ cycle · Primary Local Therapy — procedure: Plaque Brachytherapy or Enucleation
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is looking at darovasertib for people with uveal melanoma, a rare cancer of the eye. Darovasertib is given before the main treatment (this is called neoadjuvant treatment). The study is paid for by IDEAYA Biosciences.
Who can take part
- You have uveal melanoma that has not spread to other parts of the body
- You are able and willing to give written informed consent and follow the study requirements
- You are well enough to look after yourself (performance status of 0 or 1 — ask the trial team what this means)
- Your organs, such as the liver and kidneys, are working well enough
Who may not be able to
- You have already had treatment for uveal melanoma
- Your cancer has spread to other parts of the body
- You need your eye removed regardless of how well the treatment works
- You have another eye condition getting worse that would make it hard to track changes in your vision
- You have another type of cancer besides uveal melanoma
What taking part involves
- • Taking a study drug called darovasertib before your main treatment for uveal melanoma — further details of what this involves: Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 520
- Started
- 2026-01-25
- Last checked
- 2025-09
Plain English Summary
What is this study?
- • Testing a new treatment for uveal melanoma
- • Phase3 - 520 participants
- • This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with uveal melanoma
Where?
- • Metropolitan Borough of Wirral - Clatterbridge Cancer Centre - Liverpool - NWCRN - PPDS
- • London - University College Hospital
- • Sheffield - Weston Park Cancer Centre - PPDS
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
What the study is looking for
- ✓Primary non-that has spread uveal melanoma
- ✓Able and willing to provide written, agreement to take part before initiation of any study-related procedures, and in the...
- ✓ECOG 0 or 1
- ✓healthy organ
Who cannot take part
- ✗Previous treatment for UM
- ✗Evidence of that has spread 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
See the full criteria
Where Is This Study? (3 UK sites)
Clatterbridge Cancer Centre - Liverpool - NWCRN - PPDS
Metropolitan Borough of Wirral CH63 4JY, United Kingdom
University College Hospital
London NW1 2BU, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Weston Park Cancer Centre - PPDS
Sheffield S10 2TF, United Kingdom
How to Get in Touch
IDEAYA Clinical Trials
Sponsor contactCONTACT
Mwe Mwe Chao, MD
Sponsor contactCONTACT