Quisinostat for High-Risk Uveal Melanoma
Phase: Phase 2
Trial ID: NCT06932757
Treatment: Quisinostat
Stage: High-risk uveal melanoma following treatment of the primary eye tumour, with no evidence that the cancer has spread
Location: United States – University of Miami, Florida
What is this trial looking at?
This Phase 2 study is investigating whether a drug called quisinostat can reduce or delay the risk of uveal melanoma spreading to other parts of the body in people considered to have a high risk of developing metastatic disease.
The trial is for people who have already completed treatment for the melanoma in their eye, such as radiotherapy or surgery, and currently have no evidence that the cancer has spread elsewhere in the body.
Treatment given after the primary cancer has been treated, with the aim of reducing the risk of the cancer returning or spreading, is known as adjuvant treatment.
At present, there is no established adjuvant drug treatment proven to prevent uveal melanoma from spreading. This study is therefore investigating whether quisinostat could have a role in this setting.
What is quisinostat?
Quisinostat is an experimental drug known as an HDAC inhibitor.
HDACs are proteins involved in controlling how genes are switched on and off within cells. Blocking these proteins may interfere with the ability of some cancer cells to survive and grow.
Researchers want to find out whether giving quisinostat after treatment of a high-risk primary uveal melanoma can help prevent or delay metastatic disease developing.
Quisinostat is taken by mouth rather than being given through an infusion.
Who may be able to take part?
The study is specifically looking for adults with high-risk uveal melanoma who have already completed treatment of their primary eye tumour and currently have no evidence of metastatic disease.
Participants generally need to:
- be aged over 18;
- have had a primary uveal melanoma measuring at least 12 mm across its largest basal diameter before treatment;
- have a tumour classified as Class 2 using the DecisionDx-UM gene expression profiling test;
- have completed their primary uveal melanoma treatment within approximately six months (183 days) before starting the trial treatment;
- have no evidence that the melanoma has spread elsewhere in the body;
- be well enough to take part in the study; and
- be able to swallow and absorb oral medication.
Previous adjuvant drug treatment for uveal melanoma is generally not permitted.
There are additional medical eligibility requirements, including checks relating to heart function, other medications and general health.
Meeting these general criteria does not necessarily mean somebody will be eligible. Eligibility would need to be confirmed by the clinical trial team.
What does taking part involve?
Everyone taking part in this study receives quisinostat. There is no placebo or comparison treatment group.
Quisinostat is taken by mouth three times each week – on Monday, Wednesday and Friday.
Treatment is organised into three-week cycles and can continue for up to 17 cycles, which is approximately 51 weeks, provided the cancer has not spread and the treatment remains suitable and tolerable.
Participants also have regular monitoring during the study. This includes:
- blood tests;
- MRI and CT scans;
- monitoring for possible side effects; and
- checks of heart function where required.
After completing treatment, participants continue to be followed by the study team. Follow-up takes place approximately 30 days after treatment finishes and then every three months for two years.
What is the study hoping to find out?
The main aim is to determine whether quisinostat can reduce or delay the development of metastatic uveal melanoma in people considered at high risk following treatment of their primary tumour.
Researchers will look at:
- how many participants remain free from metastatic disease;
- how long people remain free from progression of their cancer;
- overall survival;
- where the cancer first returns if metastatic disease does develop;
- the safety and side effects of quisinostat; and
- biological changes that may help researchers better understand how the treatment works.
Why does Class 2 matter for this study?
This trial is specifically selecting people whose tumour has been classified as Class 2 by the DecisionDx-UM gene expression profiling test.
A Class 2 result is associated with a higher risk of uveal melanoma spreading compared with lower-risk gene expression profiles.
This requirement is specific to this particular clinical trial. Other methods of assessing metastatic risk are used within UK clinical practice, and having been described as having “high-risk” uveal melanoma by a UK clinical team does not automatically mean somebody would meet this trial’s Class 2 eligibility requirement.
Trial location
The study is being led by the University of Miami Miller School of Medicine / Sylvester Comprehensive Cancer Center in Florida, USA.
There are currently no UK trial centres listed for this study.
Anyone interested in the trial should first discuss it with their ocular oncology or oncology team. Their treating team can help establish whether the study may be relevant and whether contacting the trial centre would be appropriate.
Quisinostat is an investigational treatment and is not an approved standard adjuvant treatment for uveal melanoma. Eligibility and any decisions about treatment should always be discussed with the treating clinical team.