RecruitingPhase 2

Adjuvant Quisinostat in High-Risk Uveal Melanoma

United States63 participantsStarted 2025-05-27

Plain-language summary

The purpose of this study is to see if giving participants quisinostat will prevent participants' uveal melanoma tumor from spreading. The researchers want to find out the effects that quisinostat has on participants' condition.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Primary diagnosis of uveal melanoma (UM) with a lesion of at least 12 mm in largest basal diameter (LBD) as clinically determined by the treating Investigator. Cytologic determination of diagnosis is not required. Size is based on clinical assessment (e.g., by ultrasound or direct ophthalmoscopy) prior to enucleation or radiation therapy.
. Definitive therapy of the primary UM must have been completed within 183 days of initiating protocol therapy.
. High-risk (class 2) UM as determined by gene expression profiling (GEP; DecisionDx-UM, Castle Biosciences Inc., Friendswood, TX).
. No evidence of metastatic disease.
. Patients aged \>18 years.
. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
. Life expectancy of greater than 3 months.
. Ability to swallow and retain orally administered medication and no clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels.

Exclusion criteria

. Additional malignancy that is progressing or requires active treatment. Exceptions include the following cancers: basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer, ductal carcinoma in situ (DCIS), incidentally discovered asymptomatic thyroid cancer, elevated levels of prostate-specific antigen (PSA) stable on hormonal therapy with no otherwise detectable disease, and a previous diagnosis of malignancy that has shown no evidence of disease progression for 2 years or longer.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Distant metastasis-free survival (DMFS) Rate

Timeframe: Up to 36 months

Trial details

NCT IDNCT06932757

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-05-27

Contact for this trial

Christine Estevez

305-243-8376 cme101@med.miami.edu

View on ClinicalTrials.gov More Uveal Melanoma trials