OptimUM-10 – Darovasertib before treatment for primary uveal melanoma
Phase: Phase 3
Trial ID: NCT07015190
Treatment: Darovasertib
Stage: Primary uveal melanoma – the cancer must not have spread to other parts of the body
UK locations: University College London Hospital and The Clatterbridge Cancer Centre, Liverpool
What is this trial looking at?
OptimUM-10 is investigating whether giving a drug called darovasertib before the usual treatment for uveal melanoma can shrink the tumour and help protect the eye and vision.
This type of treatment is known as neoadjuvant treatment, which simply means treatment given before the main treatment.
Darovasertib is a tablet that blocks a protein called PKC, which is involved in the growth of many uveal melanomas.
The study is particularly interested in whether shrinking the tumour before treatment could:
- reduce the risk of significant sight loss for people who need plaque brachytherapy; or
- allow some people who would normally need their eye removed (enucleation) to receive an eye-preserving treatment instead.
Who may be able to take part?
This trial is for adults with a new diagnosis of primary uveal melanoma that has not spread elsewhere in the body.
There are two groups within the study:
Group 1 – Plaque brachytherapy
This group is for people whose tumour would normally be treated with plaque brachytherapy and who are considered at higher risk of losing vision as a result of their tumour or treatment.
Group 2 – Enucleation
This group is for people whose tumour would normally be treated by removing the eye (enucleation).
Participants generally need to:
- be aged 18 or over;
- have primary uveal melanoma with no evidence that it has spread;
- not have previously received treatment for their uveal melanoma;
- be well enough to take part in the study; and
- meet the trial’s other medical and eye-related eligibility requirements.
There are additional eligibility criteria, and meeting the points above does not necessarily mean someone will be able to join the trial. Eligibility must be assessed by the clinical trial team.
What does taking part involve?
Participants are randomly assigned to receive either darovasertib before their normal treatment or to receive their normal treatment without darovasertib.
For people receiving darovasertib, the medication is taken by mouth twice a day for up to approximately six months before their main eye treatment.
For people in the plaque brachytherapy group, the study compares:
- darovasertib followed by plaque brachytherapy; with
- plaque brachytherapy without darovasertib beforehand.
For people in the enucleation group, the study compares:
- darovasertib followed by the most appropriate treatment depending on how the tumour responds, which may include plaque brachytherapy, another form of radiotherapy or enucleation; with
- immediate enucleation without darovasertib beforehand.
Participants will continue to be followed after their treatment so researchers can look at longer-term outcomes, including vision and whether the tumour returns.
What is the study hoping to find out?
For people who would normally receive plaque brachytherapy, researchers primarily want to find out whether giving darovasertib beforehand can help reduce significant loss of vision.
For people who would normally require enucleation, researchers want to determine whether treatment with darovasertib can shrink the tumour enough to allow more people to keep their eye.
The study will also collect information about how well the treatment works, its side effects and longer-term outcomes.
UK trial locations
The trial currently lists two UK centres:
- University College London Hospital (UCLH), London
- The Clatterbridge Cancer Centre, Liverpool
Anyone interested in the trial should speak to their ocular oncology or oncology team. They can discuss whether the study may be appropriate and arrange a referral to a participating trial centre if necessary.
Darovasertib is an investigational treatment and is not currently an approved standard treatment for primary uveal melanoma. Participation in a clinical trial and treatment decisions should always be discussed with the treating clinical team.